"Clinical Research Coordinator I (Temp)"

Job Description

To serve as coordinator for studies and provide support to other team members within the confines of the protocol as directed. To support screening and participant eligibility determination, working with more senior team members to ensure compliance. To conduct activities in accordance with the protocol, regulations and Good Clinical Practice (GCP). To assist with the study life cycle from start-up to closure, i.e., collecting and recording data, recruiting and performing follow-up with participants, scheduling visits and assisting in coordination of lab and fieldwork.

Key Duties & Responsibilities

1. Collects and documents data for clinical research programs. Recruits and performs follow-up with research participants as protocols outline. Schedules visits according to research protocols.
2. Assists in coordination of lab and fieldwork. Coordinates appointments for additional procedures as necessary. Prepares for and participates in study monitoring visits. Assists with correcting findings. Participates in study meetings and conference calls.
3. Assists with the completion of Case Report Forms (CRF) according to protocol.
4. May assist with development of protocols and standard operating procedures (SOPs) for data quality assurance.
5. Performs administrative duties in support of research conduction as needed.
6. Prepares source documentation for review with investigators. May perform a variety of medical procedures under supervision.
7. May assist in compiling, editing, and proofing written reports for both internal and external administrative offices. May perform data analysis using a variety of software packages.
8. May use Electronic Data Capture (EDC) systems necessary for operations under supervision.
9. Performs other duties as assigned.

Qualifications

High School diploma or GED required.

Preferred:

We are seeking a detail-oriented Clinical Research Coordinator I for a temporary position with demonstrated proficiency in Good Clinical Practice (GCP) guidelines, regulatory compliance (FDA 21 CFR, ICH-GCP), and Electronic Data Capture (EDC) systems such as REDCap. The ideal candidate will have experience managing participant recruitment and retention, coordinating complex visit schedules across multiple protocols, and maintaining meticulous documentation including Case Report Forms (CRFs) and source documents in compliance with HIPAA and IRB requirements. Strong organizational skills are essential preparing for monitoring visits, resolving data queries, and supporting protocol development. We value candidates who demonstrate excellent interpersonal communication for explaining informed consent processes, proactive problem-solving abilities when addressing protocol deviations, and collaborative team skills to support both senior coordinators and principal investigators.