Clinical Research Coordinator - Industry Based

Clinical Research Coordinator – Industry-Sponsored Trials

We are seeking a highly organized and detail-oriented Clinical Research Coordinator (CRC) to join our growing clinical operations team. This role is ideal for a research professional with experience in industry-sponsored clinical trials involving pharmaceutical, biotechnology, and medical device studies.

As the CRC, you will coordinate and manage all aspects of clinical trial execution, ensuring compliance with regulatory requirements, sponsor expectations, and study timelines. You will work closely with investigators, staff, Clinical Research Associates (CRAs), sponsors, and study participants to support the successful delivery of high-quality clinical research. This position offers an excellent opportunity to contribute to innovative medical advancements while further developing your clinical research career in a collaborative and fast-paced environment.

Clinical Trial Coordination

• Coordinate and oversee all phases of clinical trials, including study start-up, participant recruitment, enrollment, follow-up, and close-out activities.
• Conduct protocol feasibility assessments and assist with site initiation.
• Ensure studies are conducted in compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, sponsor protocols, and institutional policies.

Participant Management

• Recruit, screen, enroll, and consent study participants according to protocol requirements.
• Schedule and coordinate study visits while ensuring participant safety and protocol adherence.
• Perform clinical assessments, including vital signs, specimen collection, and phlebotomy as required by study protocols.
• Maintain positive relationships with participants and provide ongoing education throughout the study process.

Data & Documentation Management

• Accurately collect, review, and enter clinical trial data into Electronic Data Capture (EDC) systems within sponsor-required timelines.
• Verify source documentation, informed consent forms, and study records for completeness and accuracy.
• Manage and maintain essential study documents, delegation logs, and electronic Trial Master Files (eTMFs).
• Proactively address and resolve data queries from sponsors, monitors, and data management teams.

Site Monitoring & Sponsor Engagement

• Serve as a primary point of contact for sponsors, CRAs, and external study partners.
• Host site initiation, interim monitoring, audit, and close-out visits.
• Support source data verification activities and ensure readiness for inspections and audits.
• Communicate study progress, enrollment metrics, and operational updates to sponsors and investigators.

Safety & Compliance

• Identify, document, and report Adverse Events (AEs) and Serious Adverse Events (SAEs) in accordance with protocol and regulatory timelines.
• Ensure participant confidentiality and data integrity at all times.
• Support quality assurance initiatives and maintain inspection-ready study records.

Cross-Functional Collaboration

• Collaborate with investigators, research staff, laboratory personnel, and sponsors to achieve study objectives.
• Manage multiple clinical trials across diverse therapeutic areas while maintaining high standards of accuracy and efficiency.
• Assist with resource planning and operational workflow improvements.

Required Experience

• Minimum of 2–3 years of clinical research coordination experience, preferably managing industry-sponsored clinical trials.
• Experience working across multiple therapeutic areas preferred.
• Demonstrated ability to manage study timelines, participant recruitment, sponsor communications.

Technical Knowledge & Skills

• Strong understanding of clinical research regulations, including FDA, ICH-GCP, HIPAA, and applicable compliance requirements.
• Proficiency with Electronic Data Capture (EDC) systems such as Medidata Rave, Veeva, Oracle Clinical, or similar platforms.
• Experience with eTMF management, EMR systems, and clinical research documentation practices.
• Knowledge of medical terminology and clinical development processes.
• Proficiency in Microsoft Office Suite and research data management systems.

Clinical Skills

• Experience performing phlebotomy, specimen processing, vital signs collection, and other protocol-required clinical procedures.
• Ability to review complex clinical documentation with exceptional attention to detail.
• Strong organizational, problem-solving, and time-management skills.

Certifications

• Current ICH-GCP certification required.
• Clinical research certification (CCRC, CCRP, or equivalent) preferred.

Why Join Us?

This is an exciting opportunity to play a key role in advancing innovative therapies and medical technologies. We are looking for motivated professionals who thrive in a fast-paced research environment and are committed to excellence in clinical trial execution, patient safety, and data quality. Join our team and make a meaningful impact on the future of healthcare.

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you have industry-based experience as a Clinical Research Coordinator?

Work Location: In person