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 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 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 – 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

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

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)

1. Education: Bachelor’s or Associate Degree in an Animal Science or Veterinary program preferred.
2. License/Certifications: Laboratory Animal Technician (LAT) certification required.
3. Experience: Six (6) years of animal experience required.
4. 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