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

Lead Regulatory Clinical  Research Coordinator

Summary

This position leads a dynamic and fast-paced regulatory team within the Clinical Trials Office at the MaineHealth Institute for Research, Scarborough, ME. The Regulatory Team manages the regulatory requirements of 100+ projects, from study startup through closeout. Under the supervision of the Manager – Regulatory Affairs and Quality, the Lead Regulatory Research Coordinator will plan, coordinate and implement initial orientation and ongoing training of Regulatory staff, lead team meetings, conduct quality assurance on regulatory documents, and establish efficient, effective processes to ensure regulatory compliance. They are 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. Sample responsibilities include:

• Study Coordination

• • Create and maintain regulatory documents, including the Institutional Review Board (IRB) application, research plan and the informed consent.
  • Coordinate and track submissions to IRB(s) and other entities as required during study startup and throughout the lifecycle of the project
• Compliance and Audit Coordination
  • Comply with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.
  • Prepare for inspections, audits, and monitoring visits from industry personnel and regulatory agencies including internal reviews.
  • Complete quality assurance activities on regulatory documents created by other members of the regulatory team
  • Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates expected within two years of hire.
• Collaboration
  • Develop workflows and integrated standard operating procedures.
  • Assess the feasibility of research projects in conjunction with other departments
  • Lead team and inter-team meetings as appropriate
• Communication
  • Interact with industry personnel involved with potential and ongoing scientific research. This may include obtaining and screening protocols.
  • Communicate clinical trial updates to research team.
  • Participate in inter-office and multi-department meetings and work groups. Present and communicate outcomes & guidance to research team when appropriate.
• Professional Development and Trainings
  • Adhere to MH/MHIR values, policies and procedures when providing orientation, ongoing trainings and professional development initiatives
  • Keep abreast of policy, regulatory, and Good Clinical Practice standards to support compliance through ongoing education of employees and support the organization in audit readiness
  • Participate in MHIR and CTO initiatives and teams as assigned

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

Required Minimum Knowledge, Skills, and Abilities

1. Education: Bachelor’s Degree in a Health Science or related field required.
2. License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred and required within two years of start date.
3. Experience: Two years of clinical experience in a healthcare setting required.

#66221

Research Coordinator I or II – Regulatory

Summary

This position works in a dynamic and fast-paced regulatory team within the Clinical Trials Office at the MaineHealth Institute for Research, Scarborough, ME. The Regulatory Team manages the regulatory requirements of 100+ projects, from clinical trial study startup through closeout. This Clinical Research Coordinator:

• 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 MHIR resources.
• Communicate clinical trial updates to research teams
• Assists with facilitating inspections and audits from industry personnel and regulatory agencies, including internal reviews.
• Complies with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.
• Participate in MHIR and CTO initiatives and teams as assigned

A fully onsite (in Scarborough, ME), hybrid, or remote work schedule is available for this position.

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

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.
4. Additional Skills/Requirements Required: N/A
5. Additional Skills/Requirements Preferred: N/A

#71045

Research Coordinator II – Community Engaged Research

Summary

This Research Coordinator II will work on a variety of projects in the Center for Interdisciplinary & Population Health Research (CIPHR), a division of the MaineHealth Institute for Research. This position is responsible for coordinating population health and clinical research. The successful candidate will be part of a research support team and work on projects for multiple research investigators, which can include community or clinical trials, program evaluation, and observational studies. Work includes study coordination, compliance and audit coordination, collaboration, and communication. The coordinator will design and facilitate meaningful opportunities for community engagement and will coordinate the logistics and processes that enable community members to participate fully in the research process, including outreach, scheduling, compensation, communication, and collaborative dissemination of findings. Additional functions may include contributing to aspects of research projects, such as quantitative or qualitative study design and implementation, including conception and planning, participant recruitment, data acquisition, data processing and analysis, and dissemination. Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates, or other equivalent certification, is expected within two years of hire.

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 Westbrook, ME research offices. A hybrid work schedule may be available. Time may be spent in community and 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.

#74760

Research Coordinator II – Program Evaluation

Summary

This Research Coordinator II will work on a variety of projects in the Center for Interdisciplinary & Population Health Research (CIPHR), a division of the MaineHealth Institute for Research. This position is responsible for coordinating population health, clinical research, and evaluation. The successful candidate will be part of a research and evaluation support team and work on projects for multiple research investigators, which can include community or clinical trials, program evaluation, and observational studies. Work includes study coordination, collaboration, and communication. Functions may include contributing to all aspects of quantitative or qualitative study design and implementation, including conception and planning, participant recruitment, data acquisition, data processing and analysis, and dissemination. Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates, or other equivalent certification, is expected within two years of hire.

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 Westbrook, ME research offices. A hybrid work schedule may be available. Time may be spent in community and 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.

#74893

Scientific Manager I/II

Summary

This position is for applicants interested in joining the MaineHealth Institute for Research (MHIR) to conduct and support of community engaged research as part of MHIR’s Center for Interdisciplinary Population & Health Research (CIPHR).

Responsibilities will include working with research investigators and community partners to identify health and research priorities; promoting multi-directional engagement for clinicians, researchers, and communities; developing investigator and staff skills in community engagement; coordinating logistical support for research activities; and, disseminating academic and non-academic products of community-engaged research. It is expected the Scientific Manager will be an excellent communicator and foster positive relationships among stakeholders. The Scientific Manager will be responsible for the supervision and oversight of other research staff supporting community engagement initiatives. The Scientific Manager will also be expected to be able to serve as key or non-key personnel on community engagement funding proposals, will contribute to obtaining external funding, and contribute to the strategic direction of community-engaged research within the Center for Interdisciplinary & Population Health. Experience with community health needs in the state of Maine or other rural areas is preferred. This is a career-track research staff position that offers opportunities to conduct research in collaboration with faculty scientists, clinical faculty, and community partners.

This is hybrid position located in our Westbrook, Maine location. There may be travel throughout Maine for on-site meetings with community partners and stakeholders.

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: Master’s Degree in related field required. PhD preferred.
2. License/Certifications: N/A
3. Experience: Four years of relevant experience with PhD or six years of relevant experience with Master’s Degree required.

#71086

Senior Director – Clinical Research

Summary

The Senior Director – Clinical Research will oversee the clinical arm of the research enterprise and act as a strategic liaison between MHIR and all of MaineHealth’s clinical departments. This individual will be instrumental in driving the growth and transformation of our clinical research programs, working closely with service line leaders to expand clinical trial activity across all departments, and fostering new partnerships with industry sponsors.

The Senior Director of Clinical Research will serve as the Principal Investigator for the Northern New England Clinical and Translational Research Network (NNE-CTR) grant, providing strategic oversight of its infrastructure and scientific direction. This role involves close collaboration with existing NNE-CTR administrative staff to manage grant deliverables, pilot programs, and support for junior investigators. In partnership with the Director of the Center for Clinical and Translational Science (CCTS), the Senior Director will lead the planning and submission of the next NNE-CTR renewal. Acting as the primary clinical liaison between the MaineHealth Institute for Research (MHIR) and MaineHealth clinical departments, the Senior Director will ensure alignment of research initiatives with clinical priorities. They will spearhead efforts to expand clinical trial activity across all departments and service lines, aiming for broad participation in trials. Additionally, the role supports the integration of Biobank resources, sample testing, and trial partnerships in collaboration with CAST, the Clinical Trials Office (CTO), and NorDx. The Senior Director will also contribute to research data governance, policy development, and long-term strategic planning for MHIR.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: MD or DO required; additional PhD and/or MBA or administrative training preferred.
2. License/Certifications: See Education.
3. Experience: Experience as a clinical investigator required. A history of NIH funding and clinical trial experience is preferred.
4. Additional Skills/Requirements Required: Knowledge of clinical trial regulations, operations, and infrastructure. Demonstrated success working across clinical and translational research environments. Strong relationship-building skills with physicians, researchers, and sponsors. Strategic thinker with leadership and team-building experience. Ability to communicate complex ideas clearly to diverse audiences. Familiarity with NIH grants and infrastructure programs (e.g., IDeA-CTR, COBRE, INBRE). Commitment to research integrity, mentorship, and equity in access to research. Experience with service line transformation or academic-clinical integration. Knowledge of all regulations governing the protection of human subjects in research. Experience with the development of industry partnerships and IP contracts. Experience with clinical service line transformation and academic integration.
5. Additional Skills/Requirements Preferred: N/A

#56619

Supervisor – Research Program Manager

Summary

This position is for someone interested in joining a hands-on team at the MaineHealth Institute for Research, which, under the direction of the Manager – Clinical Trials Office, will oversee staff compliance, policy, quality assurance operations, budget management, and personnel and staff coordination and contributing to the planning and implementation of the strategic vision for the Clinical Trials Office.

This Supervisor will play a key role in expanding research initiatives and ensuring quality and compliance. This position will collaborate closely with the Manager- as well as investigators across MaineHealth hospitals and clinics – to strengthen clinical research infrastructure, foster multidisciplinary engagement, and advance the growth and impact of the Clinical Trials Office.

The MaineHealth application, cover letter and a resume/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 throughout the MaineHealth network.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor’s degree and three years’ experience; master’s degree preferred
2. License/Certifications: Appropriate licensure is required
3. Experience: Demonstrated experience in administration and the management of staff
4. Visual acuity, manual dexterity, math skills and research acumen required
5. Skills should include ability to troubleshoot issues with regard to the program or office.
6. Must have good organizational and personnel management skills, communication skills, both personal and written, business planning acumen.
7. Must have a working knowledge of administrative policy and/or federal regulations e.g. DOL, USCIS, Health care, Research or other applicable field
8. Current best practice with associated technologies

#74134