Clinical Trial Site Leader

Profound Research; Munster (IN); On-site; USD 75,000 - 110,000; Full time

Job summary

Profound Research is seeking a seasoned Clinical Research Coordinator to oversee site compliance and study operations for multiple trials. You will supervise staff, ensure regulatory adherence, and collaborate with cross-functional teams on feasibility and site placement.

The role requires extensive GCP knowledge, leadership experience, and willingness to travel regionally to support sites and recruitment efforts at Profound Research locations.

Qualifications

• Associate degree or BS/BA in Life Sciences or related discipline.
• 8+ years prior experience as a clinical research coordinator.
• 3-5 years of direct line management responsibilities.
• GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.
• Experience performing clinical assessments, including vital signs, EKGs, blood draws, and lab processing.

Responsibilities

• Maintain site compliance for all clinical trial activities in accordance with protocols and regulatory requirements.
• Maintain knowledge of FDA regulations, ICH-GCP guidelines, SOPs, guidance documents, and study protocols.
• Supervise the site, conduct performance reviews, and coach staff; administer disciplinary actions if needed.
• Ensure staff training for compliance and inspection readiness.
• Collaborate with Operations and Business Development on feasibility and study placement.
• Accountable for enrollment planning and site revenue expectations.
• Coordinate as primary CRC on at least one medium to high complexity trial; train timely.
• Share best practices with other Profound site locations to raise operational competencies.
• Work with the Quality Assurance team to ensure quality and create CAPAs.
• Identify and build relationships with outside medical practices and labs to aid recruitment.
• Act as site liaison with coworkers, leadership, sponsors, CROs, and vendors.
• Ensure weekly, monthly, quarterly goals are met for sites.
• Support scalable operations infrastructure at new Profound sites.
• Other duties as assigned by leadership.

Skills

Clinical research

Regulatory compliance

Staff management

GCP certification

Education

BS/BA in Life Sciences

Job description

Profound Research is seeking a seasoned Clinical Research Coordinator to oversee site compliance and study operations for multiple trials. You will supervise staff, ensure regulatory adherence, and collaborate with cross-functional teams on feasibility and site placement.

The role requires extensive GCP knowledge, leadership experience, and willingness to travel regionally to support sites and recruitment efforts at Profound Research locations.