Director – Clinical Trials Office

Summary

The MaineHealth Institute for Research (MHIR), established in 1991, has experienced remarkable growth, driven by successful grant funding and the recruitment of world-class scientists. The institute’s full service scientific facilities foster innovative research with a particular focus on basic, translational science, population health, and clinical trials. As a part of MaineHealth, the state’s largest integrated healthcare system, MHIR collaborates with the network of nine hospitals to enable a seamless connection between scientific discoveries and their real-world application in patient care and community engagement. MHIR has state-of-the-art resources to support basic, translational. clinical research, and clinical trials.

MHIR is strategically expanding to enhance its success in biomedical and health research. To support this expansion, we are actively seeking a Director – Clinical Trials Office. Applications will be reviewed on a rolling basis until the position is filled.

The Clinical Trials Office Director reports to the Vice President for Research at MaineHealth. The Director is responsible for the development, promotion, and leadership of the Clinical Trials Office (CTO). They will support the growth of clinical research across the MaineHealth network of hospitals and outpatient clinics in collaboration with other MaineHealth Institute for Research departments by developing and by implementing innovative programmatic, strategic, and operational approaches to advance the quality and efficiency of clinical research. The Director is responsible for the oversight of all clinical trials performed across MaineHealth.

Key knowledge, skills, and abilities: Ph.D. or Master’s degree in relevant discipline preferred, Bachelor’s degree required; five or more years in a clinical or healthcare environment (preferably in an academic or clinical research non-profit setting); demonstrated thorough understanding of federal regulations governing human subjects’ research and regulatory procedures for GCPs; demonstrated excellent leadership and communication skills, including public speaking to facilitate training sessions, lead discussion groups, and deliver presentations; documented skill and experience in management of personnel, including oversight of personnel and professional development; clinical research finance and non-profit grant management experience.

Key responsibilities:

• Lead the CTO in fulfilling its mission of providing high-quality management of innovative clinical trials throughout MaineHealth.
• Lead collaborative efforts to refine, develop, and expand services offered by the CTO.
• Provide operational leadership for management, growth, and integration of MaineHealth clinical trials programs.
• Develop, review, and update appropriate guidelines and operating procedures for all Clinical Trials Office activities, ensuring compliance with all required federal, state, and institutional policies.
• Participates in the development and execution of annual operating and capital budgets.
• Oversee staff who provide oversight of clinical trials including review of protocols, budgets, and contracts.
• Ensure the supervision and professional development of the CTO staff.
• Ensure adequate resources are available to meet study needs.
• Promote a collaborative working relationship with the diverse groups of CTO staff located across the MaineHealth network.
• Promote a collaborative working relationship with other departments within MaineHealth that support clinical research.
• Maintain and promote effective working relationships with Sponsors, Contract Research Organizations, Collaborating Institutions, Principal Investigators, Research Coordinators, and research teams across MaineHealth.
• Responsible for providing assistance and support of research at Maine Medical Center
• Provide an orientation and mentoring program for new Clinical Research Coordinators (CRC).
• Provide assistance and guidance to Investigators and research staff with the coordination and management of their clinical trials.
• Promote adherence to Institutional SOPs, Good Clinical Practice and federal regulations
• Works closely with the Directors of the Office Research Ethics and Compliance, Sponsored Research Grants, MHIR Center Directors, and other leaders to support and grow research at MaineHealth.
• Works collaboratively to address simple and complex problems arising in the clinical trials. space across MaineHealth.
• Metrics and Data: (Information Management)
• Develops and oversees the management of systems, processes and tools to provide Clinical Trials metrics.
• Promote a Culture of Safety • Identify risks and hazards to patients and document mitigation efforts (i.e. monitoring safety events and completing action items, RCAs, and intensive reviews).
• Set targets and take steps to improve hand hygiene compliance.

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

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

#60625

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 Associate II – Li Lab

Summary

As a Research Associate II, you will perform a diverse range of laboratory procedures under the general supervision of Principal Investigator, Ziru Li, or her designee. This Research Associate II will conduct defined research projects with overall responsibility for inception, implementation and reporting of results in a peer-reviewed forum.

Other responsibilities include:

• Conducting standard laboratory procedures and analyses using a variety of manual techniques and instrumentation to analyze experimental data.

• Maintaining logs and notebooks of all work-related activity to assist in the preparation of materials for grants and manuscripts.

• Examining animals and specimens and measuring or weighing compounds and solutions for testing.

• Following training expectations as defined by project.

• Collaborating and communicating with internal and external laboratory members to work effectively.

• Responsible for laboratory ordering, overseeing and participating in lab maintenance, organizing lab activities, and assisting the PI with administrative duties, including lab safety inspections and IACUC protocol amendments and annual reviews.

The Li Laboratory at MaineHealth Institute for Research is at the forefront of metabolic bone research. Our focus lies in animal studies of bariatric surgery-induced bone loss and the cellular interactions between bone marrow adipocytes and other bone cells. Here is a sample of our current research projects:

Gastric Endocrine Functions in Skeletal Homeostasis (R01-funded project 09/01/2025-08/31/2029):Bariatric surgery-associated skeletal complications have been observed since the early 1990s, and lead to up to two-fold increase in fracture risk. The most common bariatric surgery is vertical sleeve gastrectomy (VSG), which leads to ~3-7% bone loss at the axial skeleton after 6-24 months. Current clinical management includes bone mineral density assessments, consumption of adequate dietary calcium, vitamin D, and protein, and performance of weight-bearing exercise. These countermeasures minimize, but do not fully prevent bone loss secondary to bariatric surgery. A better mechanistic understanding of bone loss associated with bariatric surgery is necessary to properly design and evaluate preventive and therapeutic strategies. We propose that gastric hormones contribute to bariatric surgery-induced skeletal complications. My group found gastric X/A-like cells (P/D1cellin humans), a unique endocrine cell population ,contribute to the regulation of global lipid metabolism, marrow adiposity and bone formation, suggesting a stomach-bone axis. Our goals are: 1) to determine the effects of gastric X/A-like cell-derived secretory factors on VSG-induced bone loss; and 2) to identify and characterize gastric hormones from X/A-like cells that regulate skeletal homeostasis.

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

Position availability is contingent upon grant funding.

Consideration of applicants for a Research Associate III role (MS degree and 6 years of directly related experience) is also possible.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor’s Degree in relevant field required. Master’s Degree preferred.
2. License/Certifications: N/A
3. Experience: Four years of relevant experience with a Master’s Degree or six years of experience with a Bachelor’s Degree required. Demonstrates competency in all essential functions of Research Associate I role.

#68589

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

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 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 throughout the MH network.

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.

#71102

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