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