"Clinical Research Coord I"

Position Summary

The Translational and Computational Neuroimmunology (CTCN) and the Multiple Sclerosis Center are seeking a Clinical Research Coordinator I (CRC I) who will be responsible for semi-independently coordinating our multi-center, longitudinal study, MS Brain Bank project. The CRC I will also assist with other research projects, including FDA-regulated clinical trials, under the supervision of the Principal Investigator and other members of the center’s leadership. Key responsibilities include study coordination, participant recruitment and enrollment, data collection and entry, regulatory management and compliance, and preparation for monitoring visits.

Responsibilities

• Under the supervision of the Principal Investigator and direct supervisor, support the day-to-day execution of clinical research studies across startup, active implementation, and closeout phases.
• Lead participant recruitment, screening, informed consent, enrollment, follow-up, and retention activities with minimal guidance from the supervisor.
• Execute study procedures per protocol, including specimen collection and processing and subject assessments, while ensuring subject safety and compliance.
• Enter, manage, and review study data in EMR, CTMS, EDC, REDCap, and CRFs in accordance with ALCOA-C principles.
• Maintain accurate clinical, regulatory, and study documentation.
• Serve as a point of contact for regulatory document management and related communications with sponsors, CROs, internal and external collaborators.
• Assist with IRB submissions, audits, startup, and closeout activities.
• Identify and report adverse events (AEs) and serious adverse events (SAEs), and support corrective and preventive action (CAPA) activities as needed.
• Schedule study visits, manage study supplies, process participant compensation, and provide administrative support.
• Contribute to the development of SOPs, CRFs, study tools, databases, and data capture processes.
• Act as a liaison among investigators, sponsors, compliance offices, research teams, and external partners.
• Participate in study meetings, training, and continuous improvement initiatives.
• Provide guidance to entry-level staff and, as appropriate, supervise short-term interns or volunteers.
• Perform other related duties as assigned.

Minimum Qualifications

• Bachelor’s degree or equivalent in education and experience, plus three years of related experience.

Preferred Qualifications

• Strong communication, organization, customer service, and leadership skills.
• Ability to interact and collaborate positively, constructively, and effectively with multiple stakeholders.
• Capacity to work semi-independently and collaboratively within teams in a deadline driven and multi- tasking environment.
• Able to demonstrate initiative, identify problems, and propose solutions to supervisors.
• Ability to accurately collect and record data.
• Working knowledge of Microsoft Office.
• Ability to demonstrate professionalism and flexibility.
• Willingness to learn new systems and programs.

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35 hours