Location:

CARE Fertility -

Bedford Department:

Clinical Research Reports To:

Principal Investigator Position Type:

Full-Time Job Overview:

We are seeking a dedicated, detail-oriented Clinical Research Coordinator (CRC) to join our clinical research team. The CRC coordinates day-to-day execution of clinical trials, supports regulatory compliance, and helps manage research projects from start to finish. This role is a good fit for someone who enjoys clinical research and wants to contribute in a fast-paced fertility practice. The Principal Investigator and research team retain overall scientific and regulatory accountability; the CRC supports study operations under their direction.

Key Responsibilities:

• Study management: Oversee day-to-day trial activities, including recruitment, screening, and enrollment of study participants. Help keep study milestones and timelines on track.
• Regulatory support: Support adherence to GCP, ICH, and FDA requirements, as well as institutional and sponsor-specific protocols, under the direction of the Principal Investigator and research team.
• Data collection and documentation: Complete accurate, timely data collection, documentation, and reporting. Maintain study records, including consent forms, adverse event reports, and case report forms.
• Participant interaction: Serve as a liaison among study participants, clinical staff, and sponsors. Obtain informed consent and answer participant questions about the study.
• Coordination with investigators: Work with the Principal Investigator and research team to keep study operations running smoothly. Schedule and attend study meetings and help track trial progress.
• Monitor visits: Help schedule site visits as needed, provide documentation to study monitors, and resolve monitor queries promptly during and after visits.
• Inventory management: Track and manage clinical trial supplies so study medications, equipment, and resources are available as required.

Qualifications:

Education:

Bachelor's degree in Life Sciences, or a related field preferred.

Experience:

1-2 years of experience in clinical research, clinical trial coordination, or a related field preferred. Related clinical or healthcare experience will be considered.

Knowledge:

Basic understanding of clinical trial processes, regulatory requirements, and GCP guidelines. Familiarity with clinical trial management systems (CTMS) or data management software is a plus.

Skills:

• Strong written and verbal communication skills
• Strong organizational and time-management skills
• Ability to work independently and as part of a team
• High attention to detail and accuracy
• Ability to prioritize tasks and manage more than one study timeline 8 am to 5 pm Mon-Thurs 8 am to 4 pm Fridays