Clinical Research Coordinator II – Oncology

Summary

This position is for someone interested in joining a research coordination team within the Clinical Trials Office (CTO) at the MaineHealth Institute for Research, based in Scarborough, ME. This position provides research coordination support for a dynamic and fast-paced team within the CTO. The research coordination team contributes to research by facilitating gynecological oncology clinical research – ensuring research is conducted in a manner to protect research participant safety and promote the ethical conduct of research throughout the MaineHealth network. Under the supervision of the Clinical Trials – Oncology Manager, the Clinical Research Coordinator II will assist with the regulatory management of clinical research projects, such as IRB submissions, research personnel credentialing, provisioning of access for external monitors and study file maintenance. The Clinical Research Coordinator II is expected to effectively collaborate with study Principal Investigators, Clinical Coordinators, and external and internal regulatory bodies. Strong organizational and communication skills as well as attention to detail are necessary for success. This role requires general knowledge of clinical research coordination, initiative, independent judgment, and discretion. 

A hybrid work schedule is available from our Scarborough, Maine location for this position.

The MaineHealth application, a cover letter and a resume or CV are all required elements for application.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education:  Bachelor’s degree or equivalent combination of education and experience required.
2. License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
3. Experience: Two years of clinical experience in a healthcare setting required. Meets all requirements of a Research Coordinator I.

#90920

Director of Research Compliance

Summary

The MaineHealth Institute for Research is seeking an experienced Director of Research Compliance to join our executive leadership team. Under the direction of the Vice President for Research, this Director is responsible for managing an effective research compliance program in pursuit of MaineHealth’s research programs. MaineHealth’s compliance with pertinent regulations and policies is essential to engendering public trust. This Director will actively manage research compliance; research compliance education; and function as a compliance information clearinghouse. The Director will implement and manage a compliance education program that provides support for scientific research of faculty members, staff, and students. Certification as a Certified IRB Professional (CIP) is expected.

Experience with at least several of the following will be required: IRB, IACUC, IBC, SRC, Research Misconduct, Conflict of interest, and HIPAA research issues.

The MaineHealth application, a cover letter and a resume or CV are all required elements for application to this position.

This position is a hybrid role, based at our Scarborough, ME offices.

#73949

Laboratory Animal Tech I

Summary

This Lab Animal Tech I position is designed for someone interested in participating in the day-to-day operation of the MaineHealth Institute for Research (MHIR) Animal Facility, under general supervision of the Animal Facility Manager. The MHIR Animal Facility supports research projects from over 20 Principal Investigator-driven research labs. We have world-class scientists working on the most advanced biomedical problems. The Lab Animal Tech in this position works on a team to help ensure proper care and humane treatment of approximately 10,000 mice during their use in our research. The MHIR Animal Facility is proudly and fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

This position is a full-time, onsite, benefitted role at our Scarborough, ME research facility.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Associate degree in an Animal Science or Veterinary program preferred.
2. License/Certifications: N/A
3. Experience: N/A
4. Additional Skills/Requirements Required: Ability to follow written and oral instructions and maintain accurate, legible records. Interpersonal skills necessary to maintain effective communication.

 #86951

Laboratory Animal Technician I (Per Diem)

Summary

If you’re interested in supporting research in a part-time way (which may lead to a full-time role) and maintaining your work/life flexibility, we welcome your application!

This Lab Animal Tech I position is designed for someone interested in supporting the operation of the MaineHealth Institute for Research (MHIR) Animal Facility, under general supervision of the Animal Facility Manager. The MHIR Animal Facility supports research projects from over 20 Principal Investigator-driven research labs. We have world-class scientists working on the most advanced biomedical problems. The Lab Animal Tech in this position will work on a team to help ensure proper care and humane treatment of approximately 10,000 mice for their use in research. The MHIR Animal Facility is proudly and fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC). This is a per diem position as needed to cover absences/extra workload.

This position is an onsite, per diem, and non-benefited role at our Scarborough, ME research facility. There is the possibility of this role converting to a full-time, benefited role over time and only if the candidate is interested.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Associate degree in an Animal Science or Veterinary program preferred.
2. License/Certifications: Assistant Laboratory Animal Technician (ALAT) Certification preferred.
3. Experience: Two (2) years of experience working with animals.
4. Additional Skills/Requirements Required: Ability to follow written and oral instructions and maintain accurate, legible records. Interpersonal skills necessary to maintain effective communication.

 #86016

Post-Doctoral Research Fellow – Hernandez Lab

Summary

The Hernandez Laboratory at the MaineHealth Institute for Research, Scarborough, ME is seeking a Postdoctoral Research Fellow to work on a project to study the effects of developmental excess of thyroid hormones on the sexual differentiation of the brain and sexually dimorphic neurological phenotypes of relevance to neurological conditions.

The Hernandez Lab mostly uses mouse models and its focus lies in elucidating the mechanisms by which thyroid hormone disruptions during development program adult endocrine and brain pathophysiology, as well as the susceptibility of future generations to endocrine conditions (obesity, infertility) and neurobehavioral disorders (autism, schizophrenia, depression, ADHD) via mechanisms of inter- and transgenerational epigenetics.

The Research Fellow will conduct research under the guidance of the Principal Investigator, Arturo Hernandez. The Research Fellow is encouraged to develop and pursue their own scientific ideas and research directions as they may arise from the project. The Fellow is also encouraged to apply for postdoctoral fellowships and career development grants with the guidance, support and mentorship of the Principal Investigator and other Faculty. The Fellow will have the opportunity to publish in high-impact journals, attend and present at national and international top-tier scientific conferences and contribute to fitting ongoing or new collaborative projects.

Research Directions within the overall project defined above may include -but are not limited to-:

· Role of thyroid and sex hormones cross-talk in the developing brain and relevant gene targets

· Impact on sexually dimorphic brain regions and behavioral phenotypes

· Influence of epigenetic dysregulation of thyroid hormone developmental exposure

· Mediatory effects of thyroid hormone receptors and transporters

· Mediatory effects of developmental sex hormones

· Mediatory effects on behavior of particular brain regions, cell types, systems or nuclei

 

Expectations for this Research Fellow:

· Perform, with the assistance and support of other lab personnel and the Principal Investigator, a Specific Aim in a recently funded grant concerning the role of developmental thyroid hormones in the sexual differentiation of the brain, as outlined above.

· Publish scientific contributions in journals and present at conferences.

· Mentor junior lab members and undergraduate trainees, providing mentoring in their field of expertise and training in relevant technical approaches

· Work with PI to develop new emerging research directions that may translate into grant applications competitive for grant funding.

Special consideration will be given to candidates with research background or experience in the following areas:

· Physiology and action of thyroid hormones or sex hormones

· Neuroendocrinology

· Neurobiology of sexually dimorphic brain regions

· Brain development

· Mouse behavioral tests

· Mouse models of neurological conditions

· Epigenetics

· Technical approaches used in the areas above

To apply:

Interested candidates please submit 1) the MaineHealth employment application with 2) your cover letter, 3) resume, 4) list of 3 references, and 4) a statement (<=1 page) of your research interests, experience and career goals.

More:

MaineHealth Institute for Research (MHIR) is committed to providing postdoctoral Research Fellows a robust research training experience within an engaged and inclusive community of scientists. We support the continued research training of postdoctoral fellows who have earned a PhD, MD, or MD/PhD degrees. The goal of our program is to provide a rigorous, mentored research experience that focuses on the design, implementation, and completion of novel research projects.

Research Fellows at MHIR are compensated based on years of experience and are eligible for the generous benefits package provided to MaineHealth employees.

Research Fellows participate in a robust training program that includes a seminar series with networking with local and national speakers, and presentation of their own research progress. Responsible Conduct of Research programming is run throughout the year to ensure that Research Fellows are adequately trained. We expect our postdoctoral fellows to present research findings at annual meetings and publish in peer-reviewed journals. Research Fellows are also encouraged and supported to submit applications for fellowship support or early career grants.

MHIR has an active and engaged Student and Postdoc Association that promotes professional development and a sense of community for students and postdocs. The MHIR Research Training and Education Office supports research trainees in all aspects of their training throughout their time at MHIR, including facilitation of Individual Development Plans, and annual reviews and meetings with MHIR scientific leadership. MHIR is a sustaining member of the National Postdoc Association, providing all of our students and Research Fellows the opportunity to have a free Affiliate Membership, and Research Training and Education Office Staff are members of the Graduate Career Consortium and the American Association of Medical Colleges Group on Research Education and Training (GREAT Group), connecting us with the larger national conversations about student and postdoctoral affairs.

The work location for this position is from our Scarborough, Maine research headquarters.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Doctoral Degree (e.g. PhD, MD, DO, DVM, PharmD) required.

#89636

Research Assistant I or II – Hernandez Lab

Summary

As a Research Assistant I or II (depending on the finalist’s education and experience), you will perform a broad range of laboratory procedures under the general supervision of Principal Investigator Arturo Hernandez, or his designee. The primary focus of this position will be to contribute to our currently funded project that uses mouse models to define the molecular and physiological mechanisms underlying the intergenerational epigenetic effects of paternal thyroid hormone abnormalities on energy balance and obesity, fertility, neuroendocrine function and thyroid hormone sensitivity.

 The Research Assistant will set up, operate, and maintain laboratory instruments and equipment; closely monitor experiments; make detailed observations; and accurately record and organize experimental results. Recognizing and reporting technical issues or deviations in experimental conditions is essential. Proficiency in routine laboratory techniques and strong organizational skills are expected. The successful candidate is primarily expected to work with mice (colony maintenance and genotyping, euthanasia and tissue dissection) and utilize some basic molecular techniques including qPCR and hormone ELISAs. Position availability is contingent upon grant funding. Highly qualified candidates may be considered for a higher level position provided that their experience and background are well aligned with the research project.

Dr. Hernandez’s Laboratory at MaineHealth Institute for Research is at the forefront of the physiology, metabolism and action of thyroid hormones and their roles in endocrine and neurodevelopmental conditions.  Our lab mostly uses mouse models and its focus lies in elucidating the mechanisms by which thyroid hormone disruptions during development program adult endocrine and brain pathophysiology, as well as the susceptibility of future generations to endocrine conditions (obesity, infertility) and neurobehavioral disorders (autism, schizophrenia, depression, ADHD) via mechanisms of inter- and transgenerational epigenetics.

This position is a fully onsite role at our Scarborough, ME research facility.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor’s degree required.
2. License/Certifications: N/A
3. Experience: Minimum of one year of relevant experience required. Demonstrates competency in all essential functions of a Research Assistant I – Bench role.

#89635

Research Associate I – Clinical Trials Office

Summary

We are hiring a Research Associate I to the Clinical Trials Office, a division of the MaineHealth Institute for Research. This associate will work on the Gynecology/Oncology clinical trials research team. Our Research Associate I will conduct a variety of research activities related to the collection, organization and analysis of data. They will demonstrate experience in subject recruitment and retention, study design and methods of data collection, creation and use of databases and analytic software packages and analytic techniques.

Other responsibilities will include:

• Follows all procedures and protocols as defined by the project and completes required training and follows training expectations.
• Communicates effectively to ensure the highest quality of data and the successful completion of the research.
• Develops, maintains and cleans databases and develops and maintains code books.
• Uses computers, equipment, and high technology applications to perform work duties.
• Collaborates with internal and external investigators to assist in the preparation of materials for grants and manuscripts.
• Confers with researchers, clinicians or information technology staff to determine data needs, programming requirements, design modifications, power analyses and to provide assistance with analytic activities.

This position will report to the Gynecology/Oncology Clinical Trials Manager.

This position is based at our Scarborough, ME research offices. A hybrid work schedule may be available for this position. Time may be spent in clinical settings throughout the MH network.

The MaineHealth application, cover letter and a resume/CV are all required elements for application to this position.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor’s degree in a related field required. Master’s degree preferred.
2. License/Certifications: N/A
3. Experience: One year of relevant experience with a master’s degree required. Two years of relevant experience with a bachelor’s degree required.

#78641

Research Compliance Coordinator I 

Summary

The Research Compliance Coordinator I role coordinates all aspects of the process by which research involving human subjects is reviewed to ensure compliance with institutional and federal policies and regulations.

This is a part-time position.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor’s Degree with six months of relevant experience or three years of relevant experience required.
2. License/Certifications: Certified IRB Professional preferred.
3. Experience: See “Education” 

#90637

Research Coordinator I or II – Clinical Trials Office

Summary

This Research Coordinator I or II (depending on experience) will coordinate clinical research studies for the Barbara Bush Children’s Hospital Scholars Academy – MaineHealth, via the Clinical Trials Office, a division of the MaineHealth Institute for Research. This Research Coordinator supports MaineHealth pediatric healthcare professionals with the resources needed to conduct research, quality improvement, educational and advocacy projects to address pediatric healthcare gaps and advance knowledge.

This role collaborates with principal investigators, research navigators, the MaineHealth Office of Research Ethics and Compliance, pediatric program staff and research leaders, MaineHealth member and affiliate institutions, and community partners to support project goals. The position may include direct interaction with research participants including obtaining informed consent, conducting interviews, and facilitating focus groups.

Primary duties and responsibilities for this role include:

• Support of The Barbara Bush Children’s Hospital Scholarship Academy (BBCH SA) members and their scholarly projects
• Assist in the development and writing of study protocols and other study specific documents including but not limited to: consent forms, case report forms, investigator’s brochure, recruitment materials, training slides, visit checklists, Standard Operating Procedures (SOPs), guidance documents, study manuals, etc.
• Facilitation of submissions to the MaineHealth Institutional Review Board for new studies, study amendments, reportable events and continuing review
• Study coordination including data entry, data management, regulatory oversight, and project management to assist investigators with meeting project timelines.
• Grant-writing support, the facilitation/presentation of educational activities for BBCH members and pediatric providers, support with data analysis, and BBCH SA administrative tasks.
• Teaching new investigators how to use available resources to conduct their studies, therefore a successful applicant will be comfortable quickly learning new online platforms (e.g. EDC and IRB systems)

Preferred skills for this role include:

• Excellent communication, organization, and coordination skills in order to manage many projects simultaneously and support multiple investigators
• Knowledge of the research process from study design to dissemination
• High degree of computer literacy including competency in Microsoft Office Suite, electronic data capture systems (e.g. RedCap), IRB submission platforms (e.g. Huron), and electronic health record systems (e.g. EPIC)
• Self-motivated
• Strong critical thinking skills and ability to independently resolve problems
• Working knowledge of data management software and procedures
• Strong understanding of Good Clinical Practice and Human Subjects Protection
• Ability to work independently under minimal supervision. 3+ year commitment preferred.

Coordination of studies includes:

• Identifies, screens and interviews potential study subjects.
• Explains the project and all associated benefits/risks and obtains necessary signatures.
• Ensures the safety and protection of subjects enrolled in a research study and schedules subject assessments/visits as necessary.
• Ensures all study tests, visits, and assessments are done at appropriate time intervals.
• Assesses subjects for signs of potential adverse events and reports all suspected adverse events to the appropriate personnel/regulatory agencies.
• Completes case report forms by obtaining, compiling, and maintaining necessary documentation.
• Assists with facilitating inspections and audits from industry personnel and regulatory agencies, including internal reviews.
• Collaborates with other members of the Clinical Trials team to conduct study related tasks.
• Coordinates and maintains regulatory documents, including the Institutional Review Board (IRB) application, research plan, and writing the informed consent under the direction of the appropriate MHRI resources.
• Complies with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.

This position will report to the Clinical Trials Office CTO Manager, Jamie Saunders.

Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates is preferred, or required within four years of start date.

This position is based at Maine Medical Center-Portland and will travel to our research offices in Scarborough. A hybrid work schedule may be available. Time may be spent in clinical settings throughout the MH network requiring travel to our MaineHealth community hospitals.

The MaineHealth application, cover letter and a resume/CV are all required elements for application to this position.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Associate degree preferred.
2. License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred or required within four years of start date.

#79617

Research Coordinator II 

Summary

This Research Coordinator II will work on a variety of projects in the Clinical Trials Office, a division of the MaineHealth Institute for Research. The successful candidate will be part of a research team and work on research projects for multiple investigators in various therapeutic areas across the MH network.

Responsibilities of the role include:

• Identifies, screens, and interviews potential study subjects.
• Explains the project and all associated benefits/risks and obtains necessary signatures.
• Ensures the safety and protection of subjects enrolled in a research study and schedules subject assessments/visits as necessary.
• Ensures all study tests, visits, and assessments are done at appropriate time intervals.
• Assesses subjects for signs of potential adverse events and reports all suspected adverse events to the appropriate personnel/regulatory agencies.
• Completes case report forms by obtaining, compiling, and maintaining necessary documentation.
• Facilitates inspections and audits from industry personnel and regulatory agencies including internal reviews.
• Collaborates with project management team to build budgets for research activities.
• Collaborates on the design of departmental research projects and in the development of research-related data collection methods.
• Coordinates and maintains regulatory documents, including the Institutional Review Board (IRB) application, research plan, and writing the informed consent.
• Complies with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.

The MaineHealth application, cover letter and a resume or CV are all required elements for application to this position. This position is based at our Scarborough, ME research offices. A hybrid work schedule may be available. Time may be spent in clinical settings. 

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education:  Bachelor’s Degree or equivalent combination of education and experience required.
2. License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
3. Experience: Two years of clinical experience in a healthcare setting required. Meets all requirements of a Research Coordinator I.

#82190

Research Coordinator II 

Summary

This Research Coordinator II will work on a variety of projects in the Clinical Trials Office, a division of the MaineHealth Institute for Research. The successful candidate will be part of a research team and work on research projects for multiple investigators in various therapeutic areas across the MH network.

Responsibilities of the role include:

• Identifies, screens, and interviews potential study subjects.
• Explains the project and all associated benefits/risks and obtains necessary signatures.
• Ensures the safety and protection of subjects enrolled in a research study and schedules subject assessments/visits as necessary.
• Ensures all study tests, visits, and assessments are done at appropriate time intervals.
• Assesses subjects for signs of potential adverse events and reports all suspected adverse events to the appropriate personnel/regulatory agencies.
• Completes case report forms by obtaining, compiling, and maintaining necessary documentation.
• Facilitates inspections and audits from industry personnel and regulatory agencies including internal reviews.
• Collaborates with project management team to build budgets for research activities.
• Collaborates on the design of departmental research projects and in the development of research-related data collection methods.
• Coordinates and maintains regulatory documents, including the Institutional Review Board (IRB) application, research plan, and writing the informed consent.
• Complies with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.

The MaineHealth application, cover letter and a resume or CV are all required elements for application to this position. This position is based at our Scarborough, ME research offices. A hybrid work schedule may be available. Time may be spent in clinical settings. 

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education:  Bachelor’s Degree or equivalent combination of education and experience required.
2. License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
3. Experience: Two years of clinical experience in a healthcare setting required. Meets all requirements of a Research Coordinator I.

#83566

Research Data Analyst II

Summary

This position is for applicants interested in joining an analytics team who are working with investigators in the MaineHealth Institute for Research’s Center for Interdisciplinary Population & Health Research (CIPHR), which is contributing to research in the areas of clinical and population health. The Research Data Analyst II will provide qualitative, quantitative, and/or mixed-methods analytic support to faculty scientists and clinical investigators across MaineHealth. This position supports a diverse portfolio of research and evaluation projects, including clinical trials, observational studies, community-engaged research, and program evaluation. The Research Data Analyst II will be responsible for data management, data cleaning, descriptive and inferential statistical analyses, and preparation of analytic results for investigators and research teams. The analyst will work directly with investigators to understand project goals, develop analytic approaches, interpret findings, and communicate results in written and verbal formats. Successful candidates will possess a strong understanding of the research process, excellent communication skills, and a commitment to collaborative team science. Following onboarding and training, the Research Data Analyst II will independently perform analyses using methodologies consistent with established policies, procedures, regulatory requirements, and best practices in research. Applicants should be comfortable working across a variety of clinical and population health topics and managing multiple projects simultaneously. Proficiency in R/Posit statistical software is preferred, as most analyses within the department are conducted using R/Posit. Opportunities for continued professional growth and development of advanced analytic skills are available.

A fully remote (except from Alaska, California, Colorado, Nevada, Puerto Rico, or Washington D.C.) or flexible on-site/off-site work schedule from our Scarborough, ME offices is available for this position. There is an expectation of availability for meetings that can occur between 8:30 am and 4:30 pm Eastern time.

The MaineHealth application, a cover letter, and a resume or CV are all required elements for application to this position.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor’s degree required; master’s degree preferred.
2. License/Certifications: N/A
3. Experience: Three years of experience analyzing data required, preferably in a healthcare setting. Demonstrates competency in all essential functions of a Research Data Analyst I role.

#82600