Clinical Research Coordinator

Tekton Research; New Carlisle (OH); Vor Ort; USD 42.000 - 58.000; Vollzeit

Zusammenfassung

Tekton Research is seeking a detail-oriented Clinical Research Coordinator to manage daily trial activities and ensure protocol adherence. This role coordinates with investigators, sponsors, and regulatory bodies to maintain data integrity and participant safety.

Responsibilities include participant recruitment, specimen handling per protocol, regulatory documentation, and collaboration across multidisciplinary teams to ensure timely study execution and audits readiness.

Qualifikationen

• Bachelor’s degree in Nursing, Biology, Health Sciences, Public Health, or related field preferred.
• 6–12 months CRC experience or more.
• Working knowledge of GCP, FDA regulations, ICH guidelines, and clinical research processes.
• Experience with pediatric and adult phlebotomy and specimen processing.
• Strong organizational and time-management skills with the ability to prioritize multiple studies.
• Experience maintaining regulatory documentation and source records.
• Proficiency with EDC systems and Microsoft Office applications.
• Excellent verbal and written communication skills.
• Ability to work independently while collaborating with multidisciplinary teams.

Aufgaben

• Coordinate and manage all aspects of assigned clinical trials from start-up through close-out.
• Recruit, screen, consent, and schedule study participants according to protocol requirements.
• Collect, process, package, and ship laboratory specimens according to protocol and sponsor requirements.
• Maintain source documentation, regulatory binders, and study records in compliance with GCP, FDA regulations, and policies.
• Monitor participant safety and promptly identify, document, and report adverse events.
• Prepare and submit regulatory documents, including IRB submissions and protocol amendments.
• Collaborate with investigators, sponsors, monitors, and study staff to ensure successful study conduct.
• Assist with monitoring visits, sponsor audits, and regulatory inspections.
• Utilize EDC and CTMS to maintain accurate study data.
• Ensure protocol compliance while maintaining participant care and research integrity.

Kenntnisse

GCP knowledge

Phlebotomy experience

Time management

Organizational skills

EDC systems

CTMS

Microsoft Office

Verbal and written communication

Independent work

Ausbildung

Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or related field

Tools

EDC systems

CTMS

Microsoft Office

Jobbeschreibung

Tekton Research is a growth-oriented clinical research organization committed to conducting high-quality clinical trials that advance medical knowledge and improve patient care. We are a collaborative, values-driven team that believes in Focus, Discipline, and Accountability. At Tekton Research, we take pride in doing excellent work while fulfilling our mission of Making Life Better.

We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in a supportive and fast-paced research environment.

Position Summary:

The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical research studies, ensuring compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. The CRC serves as the primary liaison between investigators, sponsors, study participants, and regulatory agencies while ensuring participant safety, data integrity, and successful study execution.

This role requires excellent organizational skills, strong attention to detail, and the ability to manage multiple clinical trials simultaneously in a dynamic environment.

Key Responsibilities:

• Coordinate and manage all aspects of assigned clinical trials from study start-up through close-out.
• Recruit, screen, consent, and schedule study participants according to protocol requirements.
• Collect, process, package, and ship laboratory specimens according to protocol and sponsor requirements.
• Maintain accurate source documentation, regulatory binders, and study records in compliance with GCP, FDA regulations, and institutional policies.
• Monitor participant safety and promptly identify, document, and report adverse events.
• Prepare and submit regulatory documents, including Institutional Review Board (IRB) submissions, continuing reviews, and protocol amendments.
• Collaborate with investigators, sponsors, monitors, and study staff to ensure successful study conduct.
• Assist with monitoring visits, sponsor audits, and regulatory inspections.
• Utilize Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS) to maintain accurate study data.
• Ensure protocol compliance while maintaining the highest standards of participant care and research integrity.

Required Qualifications:

• High school diploma or GED required; Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or a related field preferred.
• Minimum of six months to one (1) year of Clinical Research Coordinator experience.
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and clinical research processes.
• Experience with pediatric and adult phlebotomy and specimen processing.
• Strong organizational and time management skills with the ability to prioritize multiple studies.
• Experience maintaining regulatory documentation and source records.
• Proficiency with Electronic Data Capture (EDC) systems and Microsoft Office applications.
• Excellent verbal and written communication skills.
• Ability to work independently while collaborating effectively with multidisciplinary teams.

Preferred Qualifications:

• Advanced degree in Nursing, Public Health, Clinical Research, or a related healthcare field.
• Experience working on industry-sponsored or multi-center clinical trials.
• Familiarity with clinical monitoring, participant recruitment, and retention strategies.

Why Join Tekton Research?

At Tekton Research, you'll join a team dedicated to excellence, innovation, and improving lives through clinical research. We foster a collaborative culture where professional development is encouraged, contributions are valued, and every team member plays an important role in advancing healthcare.