Clinical Research Coordinator

4 weeks ago

Sterling, United States Monster Full time

Job Description | Clinical Research Coordinator

Title | Clinical Research Coordinator

Location | Open

Department | Clinical Operations

Reports To | Director of Clinical Operations

Overview

The Clinical Research Coordinator (CRC) is responsible for activities associated with planning, initiating, coordinating, and implementing clinical trials within the SOFIE FAPI program under the direction of the Director of Clinical Operations. The CRC will maintain the Electronic Data Capture (EDC) system and serve as a liaison between SOFIE, clinical trial sites, and vendors. The CRC will also manage and support sites to reconcile study queries, address site issues, and generate reports as needed.

Essential Duties and Responsibilities

Provides study management, support, and coordination for FDA-regulated clinical research trials under the supervision of the Director of Clinical Operations.

Perform data management activities on the EDC system and generate reports as necessary.

Serve as a liaison with vendors, including tissue analysis support, image analysis, data management and laboratory services, and clinical personnel as necessary.

Responds to correspondence, queries, and informational requests in a timely manner.

Demonstrates compliance with Good Clinical Practice (GCP), Study Protocol, and any applicable healthcare and research regulations.

Support sites with patient recruitment, enrollment, scheduling, and consent efforts.

Ensure timely response to adverse events and any deviations per SOFIE guidelines.

Responsible for completion of necessary documents for IRB or FDA in a timely manner.

Work closely with the Regulatory lead to ensure appropriate data and documents are in place in support of regulatory filings.

Perform additional duties and responsibilities as requested by Director of Clinical Operations or Chief Scientific Officer.

The candidate is expected to travel 10% of time.

Qualifications and Requirements

Bachelors degree or Masters degree in Sciences or related field.

Minimum 2 years experience as Clinical Research Coordinator or relevant research experience.

Certified Clinical Research Coordinator (SOCRA or ACRP) preferred

Attention to detail and strong organization capabilities.

Strong interpersonal communication skills.

Ability to take feedback constructively and function in a team-oriented work environment.

Knowledge of Good Clinical Practices and FDA regulatory guidelines regarding clinical research.

Project management and coordination skills.

Proficient in MS Office applications required.

Ability to work independently with minimal supervision in a remote setting.

PDN-9b72623f-101b-4b85-acb3-a1bcab13e9f2

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