Senior Clinical Research Coordinator

HIGHLIGHTS

• $35 - $40/hr based on experience
• On site Mon - Fri in St. Louis, MO
• Work with cutting edge cardiology research trials!
• Opportunity for growth into Site Manager and Site Director level!

The Company

Our client manages Phase II - IV clinical research trials out of their outpatient, physician-led clinical research site. The department has participated in significant studies involving heart failure, coronary artery disease, and anticoagulant therapies. By partnering with pharmaceutical and medical device companies, they give eligible patients access to emerging therapies while contributing to clinical advancements and improved cardiovascular outcomes.

The Role

The Sr. CRC will coordinate sponsor backed research studies from start-up, conduct, and close-out in accordance with company SOPs, policies and procedures, federal regulations, medical ethics, Good Clinical Practice, ICH guidelines, IRB requirements, and sponsor protocol requirements.

• Lead site-level start-up activities for assigned protocols: regulatory binder build-out, ICF and source document development, supply ordering, and readiness for site initiation visits.
• Read and hold full command of each assigned protocol including the mechanism of action, standard of care comparator, and rationale for the eligibility and safety requirements written into the protocol.
• Own recruitment strategy for assigned protocols: chart review, referral coordination with treating oncologists, and pre-screening against inclusion/exclusion criteria.
• Conduct the informed consent discussion, ensuring the participant and family understand the diagnosis context, the trial's purpose, and what the treatment history and disease state mean for their specific eligibility.
• Perform and oversee protocol-specified clinical procedures independently, applying full command of the participant's disease state, prior treatment history, and the clinical rationale behind each assigned procedure
• Independently schedule, conduct, and manage the full cycle of patient visits per protocol and the sponsor's timeline.
• Coordinate with the pharmacy team on investigational product accountability for assigned protocols: dispensing, counting, storage condition monitoring, drug reconciliation at each visit and at study close-out, and destruction documentation, all reconciled against the drug accountability log without error.
• Support the PI/Investigator to identify, grade, and report adverse events and serious adverse events per protocol timelines and Flourish SOPs;
• Oversee all lab processing for assigned protocols: kit management, processing, storage conditions, shipping, and chain-of-custody documentation, ensuring nothing is missed in a patient population where a lab error is a safety issue, not just a data issue.
• Maintain complete, contemporaneous, accurate source documentation and study files (filing, binder management, logs) that will hold up to sponsor and regulatory review without correction.
• Prepare for and host monitoring visits; resolve data queries directly with the monitor, applying clinical judgment where the answer isn't a simple correction.
• Enter and reconcile CTMS billing and visit-based charges for assigned protocols against the study budget, flagging discrepancies before they become a billing compliance issue.
• Support sponsor audits and regulatory inspections for assigned protocols: pulling requested source documents, answering procedural questions, and implementing corrective actions assigned to them.
• Prepares for and supports sponsor site visits, ensuring documentation readiness and timely resolution of monitoring findings

Qualifications

• 4 years of experience as a CRC
• Strong understanding of clinical research regulations, GCP, IRB requirements, study start-up, and regulatory documentation
• Ability to work on site Mon - Fri in St. Louis
• Leadership skills preferred