Senior Clinical Research Coordinator

Tekton Research Inc•Denver, CO

1d•Onsite

About The Position

The Senior Clinical Research Coordinator is responsible for the overall management of assigned clinical trials, including both operational and administrative functions such as regulatory compliance. This role requires clear and consistent communication with study sponsors, monitors, CROs, the Principal Investigator (PI), and the Site Manager. Strict adherence to site SOPs is required. The Senior CRC oversees daily study operations, ensures protocol compliance, and represents the site in a professional, ethical, and positive manner at all times.

Requirements

High school diploma or GED required
3–5+ years of clinical research experience required

Nice To Haves

Experience leading 6–8 clinical studies preferred
Experience training and mentoring junior coordinators
Strong ability to work independently and collaboratively within a team
CCRC or CCRP certification preferred
Some college preferred

Responsibilities

Manage day-to-day operations of assigned clinical trials
Communicate study information clearly to investigators, sponsors, and study participants/caregivers
Train study team members and monitor study activities to ensure compliance with protocols and applicable regulatory requirements (local, state, federal, and institutional)
Ensure source documentation is completed accurately and contemporaneously during participant visits
Enter source data into EDC systems within 48 hours of participant visits
Maintain inventory of lab and study supplies; order supplies or delegate ordering to Research Assistant as needed
Attend investigator meetings with the Principal Investigator, ask relevant questions, and gather key study information
Participate in site initiation visits and conduct site tours as required
Coordinate with recruitment/business teams to support effective study enrollment strategies
Maintain accurate study records including case report forms, drug accountability logs, and related documentation
Communicate with laboratories and investigators regarding lab results and findings
Order investigational drugs or devices required for study completion
Oversee specimen handling, including requisition, collection, labeling, storage, and shipment
Perform protocol-specific procedures (e.g., participant interviews, vital signs, ECGs, and specimen collection)
Record adverse events and side effects and collaborate with investigators on sponsor reporting requirements
Coordinate sponsor monitoring visits and maintain ongoing sponsor communication
Resolve EDC queries within 24 hours of issuance
Manage investigational product accountability, including receipt, storage, dispensing, reconciliation, and reporting of discrepancies
Maintain master study logs (ICF, patient ID, enrollment, etc.)
Support preparation for and participation in quality assurance audits
Ensure proper drug storage, labeling, and immediate placement into secure storage upon receipt
Maintain accurate daily temperature logs as required
Prepare source documents in advance of participant visits
Maintain up-to-date training, delegation, and study logs
Ensure timely completion and PI review of all safety reports
Serve as a subject matter expert in clinical research, providing guidance and support to peers
Perform other duties as assigned