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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
Program Coordinator
Summary
This position is for someone interested in becoming a member of the MaineHealth Institute for Research (MHIR) Staff Services team, based in Scarborough, ME. This position will report to the team’s Operations Manager and will contribute to the MHIR research mission by providing excellent and proactive administrative support for internal and external constituents.
A sample of the essential duties planned for this position are:
- As the primary point of contact for reception at the 81 Research Drive facility, demonstrate professionalism in welcoming guests and visitors to MHIR
- Reconcile, answer questions, and develop expertise in the policies and mechanics of the MaineHealth timekeeping system for research institute employees
- Maintain responsibility for deliveries at the front desk of our research headquarters
- Manage a portfolio of tasks related to personnel changes and employee/non-employee onboarding & offboarding, with MS Office and task management tools
- Demonstrate critical thinking and continuous learning to create systems and to apply modern technologies for greater efficiency in the team’s body of work
The person in this position will perform both administrative and professional duties in support of MHIR leaders. They will independently prioritize assigned tasks, work in close alliance with Staff Services team members and other teams at MHIR and apply continuous process improvement in executing assigned projects. This person will assure all program-related activities are conducted successfully and on time, will function as a liaison with all levels of staff, and be a liaison to the greater MaineHealth community.
This position is based at 81 Research Drive, Scarborough, ME. A flexible work schedule may be available.
A MaineHealth application is required for this position, a cover letter and a resume or CV are also requested by the hiring manager.
Minimum Knowledge, Skills, and Abilities (KSAs)
- Education: Associate or bachelor’s degree preferred.
- License/Certifications: Driver’s license may be required based on department business need.
- Experience: One year of experience in healthcare or related work experience required. Some roles may require experience in a specific program area.
- Additional Skills/Requirements Required: Strong computer skills.
#83750
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)
- Education: Bachelor’s degree in a related field required. Master’s degree preferred.
- License/Certifications: N/A
- 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 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)
- Education: Associate degree preferred.
- 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)
- Education: Bachelor’s Degree or equivalent combination of education and experience required.
- License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
- 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)
- Education: Bachelor’s Degree or equivalent combination of education and experience required.
- License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
- 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)
- Education: Bachelor’s degree required; master’s degree preferred.
- License/Certifications: N/A
- 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
Staff Scientist I
Summary
This position is for applicants interested in joining the Yanming Li Lab of the MaineHealth Institute for Research (MHIR). Dr. Li’s laboratory is at the forefront of vascular biology and cardiovascular disease research, through innovative studies on the molecular and cellular mechanisms of aortic aneurysms and dissections. Our focus lies in uncovering the genetic, epigenetic and metabolic switches that govern aortic disease initiation and progression. By leveraging single-cell and multi-omics methodologies, we aim to understand how genomic alterations influence epigenetic regulation, drive dynamic cellular responses, and reveal novel therapeutic targets for aortic diseases.
The Role:
The Staff Scientist I is expected to investigate the molecular mechanisms of aortic aneurysms and dissection-associated genetic variants underlying the initiation and development of TAAD, ultimately paving the way for the development of treatments. The successful candidate will perform integrative analyses of GWAS, scATAC-seq, Cut&Run-seq, chromatin conformation (Hi-C), and scRNA-seq data to pave the way for the development of new treatments.
Successful candidates will have:
- PhD in Bioinformatics or Genomics
- At least five years of postdoctoral training
- Demonstrated experience in population genetics and epigenetics
- Proven proficiency in single-cell and multi-omics integration analysis
The Staff Scientist I role assists in conducting a variety of research activities:
- Managing grants or projects
- Writing grants and obtaining funding for major research projects assigned by the Principal Investigator
- Writing project reports
- Monitoring project budgets
- Mentoring Learners, as assigned
- Ensuring compliance with all state and federal regulations pertaining to safety, ethical conduct of research, and financial reporting to funding agencies.
This position is a fully onsite role at our Scarborough, ME research facility.
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)
Education: Doctoral Degree in relevant biomedical discipline required. Completion of post-doctoral training required.
#82590
Supervisor – Animal Facility
Summary
This Supervisor – Animal Facilities – MaineHealth Institute for Research supervises daily tasks, guides workflow, and mentors Lab Animal Technologists. The Supervisor leads in the Manager’s absence and ensures regulatory compliance. They perform animal procedures and manage the health monitoring program for lab animals.
Minimum Knowledge, Skills, and Abilities (KSAs)
- Education: Bachelor’s or Associate Degree in an Animal Science or Veterinary program preferred.
- License/Certifications: Laboratory Animal Technician (LAT) certification required.
- Experience: Six (6) years of animal experience required.
- Additional Skills/Requirements Required: Knowledge of laboratory techniques and terminology, laboratory policies and procedures, and proper handling and care of animals. Excellent working knowledge of acceptable standards of care, use, handling and treatment of animals in research.
#77978