Assistant Clinical Research Coordinator / Clinical Research Coordinator

We are seeking a dynamic, detail-oriented Assistant Clinical Research Coordinator (Assistant CRC) or Clinical Research Coordinator (CRC) to support the planning, initiation, and execution of clinical trials. The level will be determined based on the selected candidate’s qualifications and experience. In this role, you will coordinate study activities, maintain regulatory and study documentation, support participant safety, and ensure accurate, high-quality data collection in compliance with FDA regulations, ICH Good Clinical Practice (GCP), and HIPAA. You will collaborate closely with investigators, sponsors, monitors, and participants to facilitate smooth study operations and timely study progress.

Responsibilities

· Prepare, compile, and submit regulatory documents to the IRB and sponsor; maintain and update the regulatory binder/Investigator Site File (ISF).

· Support study start-up and initiation activities, including confirming site readiness and ensuring study training is completed and documented for all applicable staff.

· Set up and maintain study source documentation/eSource (e.g., RealTime eSource, CRIO, and/or paper source) as required by protocol and site process.

· Obtain investigator/physician signatures on source and regulatory documents in a timely manner.

· Support participant recruitment efforts, including pre-screening walk-ins and assisting the recruitment team as needed.

· Coordinate participant screening, enrollment, scheduling, and visit logistics to maintain protocol timelines.

· Facilitate the informed consent process in accordance with ICH GCP and applicable regulations; educate participants on protocol expectations and confirm understanding.

· Perform and/or coordinate protocol-required procedures accurately and in accordance with the protocol and delegated responsibilities.

· Track participants between visits (e.g., outreach and follow-up) to reduce lost-to-follow-up; monitor participant compliance (e.g., eDiary compliance, when applicable).

· Monitor and document participant safety; promptly coordinate with the investigator to identify, document, and report adverse events (AEs) and serious adverse events (SAEs) per protocol and reporting requirements.

· Process, handle, ship, and track laboratory specimens according to protocol, lab manuals, and applicable regulations; maintain complete documentation for audit readiness.

· Maintain ongoing communication with participants, sponsors, monitors/CRAs, and site study personnel via phone, email, and other channels as appropriate.

· Complete case report forms and enter/update data accurately in the electronic data capture (EDC) system in accordance with protocol and contractual timelines.

· Support monitoring visits, query resolution, and data corrections in collaboration with monitors/CRAs.

· Receive, store, dispense, and reconcile investigational product (IP/IMP) per protocol; maintain accurate accountability records and support dosing compliance.

· Maintain study-specific supplies, equipment, and materials required for study conduct.

Support study close-out activities, including reconciliation, archiving, and document retention per sponsor/site requirements

Qualifications

· Experience in clinical research and/or a healthcare setting; role level (Assistant CRC vs. CRC) will be determined based on experience and demonstrated independence in study coordination.

· Working knowledge of FDA regulations, ICH GCP guidelines, and HIPAA requirements; ability to maintain participant confidentiality and privacy.

· Experience with participant-facing clinical procedures such as vital signs, phlebotomy/blood sampling, and clinical documentation (as applicable to the role and delegation of duties).

· Familiarity with EMR systems and electronic clinical trial systems (e.g., EDC, eSource); ability to maintain accurate, audit-ready records.

· Ability to review complex documentation for accuracy, completeness, and protocol/regulatory compliance; timely follow-through on corrections and action items.

· Strong organizational skills, attention to detail, and ability to multitask in a fast-paced environment; clear written and verbal communication skills.

· ICH GCP training/certification from a recognized provider is highly desirable (or willingness to obtain upon hire).

· Knowledge of clinical development processes across trial phases is advantageous.

Pay: $22.00 - $35.00 per hour

Benefits:

• 401(k) matching
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Work Location: In person