On-site Clinical Research Coordinator — Impactful Trials

Profound Research; Munster (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement plan

Professional development support

Job summary

Profound Research in Munster, IN seeks a Clinical Research Coordinator to manage all clinical trial activities under supervision, ensuring compliance with study protocols, laws, and company values. The role emphasizes timely training completion (GCP, IATA) and mentorship of staff in trial conduct.

You will coordinate study start-up, vendor management, subject recruitment, data collection, and adverse event reporting while maintaining meticulous documentation and effective communication with

Qualifications

• Bachelor’s degree and 2 years relevant experience in the life science industry OR
• Associate’s degree with 4 years relevant experience in the life science industry OR
• High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year Clinical Research Coordinator experience
• Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role
• Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens
• Proficient ability to work independently, plan and prioritize with minimal guidance
• Excellent attention to detail, organization, and communication with varied stakeholders
• Ability to work as a team player with the ability to adapt to changing schedules and assignments

Responsibilities

• Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
• Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills.
• Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up.
• Ensure good documentation practices are applied by all team members when collecting, maintaining and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products.
• Other duties as assigned.

Skills

Independent work

Attention to detail

Communication skills

Team player

Education

Bachelor’s degree

Associate’s degree

High School Diploma

Tools

GCP certification

CCRC certification

IATA certification

Job description

Profound Research in Munster, IN seeks a Clinical Research Coordinator to manage all clinical trial activities under supervision, ensuring compliance with study protocols, laws, and company values. The role emphasizes timely training completion (GCP, IATA) and mentorship of staff in trial conduct.

You will coordinate study start-up, vendor management, subject recruitment, data collection, and adverse event reporting while maintaining meticulous documentation and effective communication with