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 Assistant II – Myocardial Biology & Heart Failure Research Lab

Summary

As a Research Assistant II, you will perform a diverse range of laboratory procedures under the general supervision of Principal Investigators, Sergey Ryzhov and Douglas Sawyer or their designee. This Research Assistant II will conduct standardized laboratory procedures and analyses using a variety of manual techniques and instrumentation to analyze experimental data. They will be responsible for setting up, operating, and maintaining laboratory instruments and equipment, closely monitoring experiments, making observations, and accurately recording results. They will recognize and report problems or deviations in experimental conditions. Proficiency in routine techniques and procedures relevant to the lab’s overall goals is expected. Other responsibilities include:

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

The MBHFR Laboratory at MaineHealth Institute for Research is at the forefront of basic and translational cardiovascular research. Our focus lies in cardiac repair and regeneration after local and global ischemic injuries. A sample of our research projects includes:

• The characterization of a novel subset of highly proliferative cardiac stromal cells with high potential to repair the heart after a heart attack

• Development of novel approaches to control immune-driven inflammation to reduce myocardial tissue damage

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

Position availability is contingent upon grant funding.

Consideration of applicants with varied experience is also possible.

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.

#66208

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

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 Coordinator

Summary

This position is for someone interested in joining a hands-on team at the MaineHealth Institute for Research. This Research Coordinator Supervisor will work at the direction of the Manager, Clinical Trials Office, and will be responsible for research coordination: including but not limited to supervising staff, overseeing training and serving as an educational resource for research studies.

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.

Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Bachelor’s degree, or equivalent combination of education and experience is required.
2. License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred.
3. Experience: 3-4 years of research experience required. Experience in a clinical setting preferred.
4. Additional Skills/Requirements Required: Experience as a leader or a mentor required.
5. Additional Skills/Requirements Required: Ability to function independently and as part of a team.

#61525