Primary Function:

The Clinical Research Project Coordinator II provides oversight and support in the research and non-clinical administrative aspects of projects involving human subjects. The incumbent implements and oversees the daily operations of the study which include monitoring participant recruitment, implementing protocols, managing research data and samples, and supervising staff. Assists with administrative functions including IRB compliance, maintaining supplies, writing proposals, ensuring compliance with grant criteria, assisting in marketing initiatives, and providing reports. The incumbent maintains data required by sponsors, aids in preparing project-related reports, and serves as a resource to all entities/individuals involved in the specific research study. Additionally, the incumbent assists in preparing and reviewing submissions to sponsors, including budgeting, and/or maintaining and managing project budgets.

The Clinical Trials Center Lead Coordinator provides strategic and operational leadership for the Department of Family Medicine Clinical Trials Center at Care New England. This position oversees all aspects of clinical trial operations, including regulatory compliance, budget management, patient recruitment, staff supervision, and data integrity. The Lead Coordinator manages a team of research staff and serves as the primary point of contact for sponsors, regulatory bodies, and institutional stakeholders. The position supports both industry-sponsored and federally funded clinical trials across the department's research portfolio.

Responsibilities

• Manages research project(s) involving human subjects
• Trains and supervises project specific staff (Clinical Research Assistants I-III, volunteers, students, consultants, etc); records HR issues as needed
• Assists in the planning, implementation, and management of project data
• Promotes the project(s) through marketing, website, other sources, etc.
• Coordinates project meetings including creating agendas and drafting minutes
• Collaborates on presentations, publications, and dissemination of project results, as requested
• Supervises biospecimen collection, packaging, shipping, and infection control procedures
• Aids in preparation of IRB protocols, amendments, annual reviews, risk assessments, adverse event reports, and informed consent documents; communicates with IRB throughout submission and review process
• Supports Principal Investigator in preparing regulatory reports, including convening DSMB meetings and writing DSMB reports, and assisting with sponsor progress reports.
• Helps prepare and review grant submissions, including budgets, according to sponsor guidelines
• Manages financial functions related to grant and budget compliance
• Interfaces with grants management office and sponsors

Qualifications and Specifications:

• Bachelor's Degree in a health-related, scientific, or relevant field
• Minimum 3 to 5 Years of Experience
• CCRP, CCRA, or ACRP-CP preferred
• Excellent communication skills and analytic abilities
• Basic computer skills, e.g. familiarity with Microsoft software, completing spreadsheet/data entry
• Ability to work with diverse populations and support an inclusive, culturally responsive environment

Sponsorship is not available for this position

Highly Desired Qualifications

• Minimum of 5 years of experience coordinating or leading clinical trials
• Demonstrated expertise in FDA regulations, ICH-GCP guidelines, and IRB processes
• Experience with clinical trial budget development and management
• Proven supervisory experience with demonstrated ability to lead and develop teams
• Proficiency with electronic data capture systems and clinical trial management software
• Excellent organizational, communication, and interpersonal skills

Care New England Health System (CNE) and its member institutions, Butler Hospital, Women & Infants Hospital, Kent Hospital, VNA of Care New England, Integra, The Providence Center, and Care New England Medical Group, and our Wellness Center, are trusted organizations fueling the latest advances in medical research, attracting top specialty-trained doctors, and honing renowned services and innovative programs to engage in the important discussions people need to have about their health.

Americans with Disability Act Statement: External and internal applicants, as well as position incumbents who become disabled must be able to perform the essential job-specific functions either unaided or with the assistance of a reasonable accommodation, to be determined by the organization on a case-by-case basis.

EEOC Statement: Care New England is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status

Ethics Statement: Employee conducts himself/herself consistent with the ethical standards of the organization including, but not limited to hospital policy, mission, vision, and values.