Clinical Research Coordinator

Position Summary:

The Research Coordinator is responsible for coordinating multiple research protocols and serving as a liaison between investigators, sponsors, and site personnel. Under supervision, this role develops a foundational understanding of research operations, compliance standards, and human subject research regulations.

Key Responsibilities:

• Coordinate daily operational activities across multiple research studies.

• Serve as the primary contact between site research teams, sponsors, and supervisors.

• Collaborate with internal departments such as finance, administration, and the local IRB.

• Manage study timelines from feasibility submission through study closeout.

• Review study design, inclusion/exclusion criteria, and ensure accurate informed consent.

• Maintain data integrity through detailed source document review and accurate data entry.

• Create study-specific documentation tools when not provided by sponsors.

• Manage shipment tracking for drugs, devices, and study supplies.

• Document and report adverse events, deviations, and protocol violations.

• Attend investigator meetings, site visits, and clinical research coordinator (CRC) meetings.

• Review and address monitoring or audit findings in collaboration with supervisors.

Qualifications:

• Bachelor's degree in a scientific, healthcare, or related field preferred, or equivalent combination of education and experience.

• Certified Clinical Research Coordinator (CCRC) certification preferred.

Knowledge & Skills:

• Working knowledge of organizational policies and research procedures.

• Basic understanding of ICH guidelines, CFR regulations, and medical terminology.

• Strong communication, organizational, and time management skills.

• Proficiency in routine clinical trial procedures such as ECGs, phlebotomy, specimen handling, and shipping.

• Meticulous attention to detail and ability to manage multiple priorities.

• Self-motivated with strong interpersonal and problem-solving abilities.

Additional Requirements:

• Must adhere to the organization's Code of Conduct and Mission & Values.

• Completion of assigned training modules by designated deadlines.

• Demonstrate competency in required clinical tasks (e.g., ECG, specimen processing), with ongoing evaluation and training as needed.