Clinical Research Coordinator

Sarasota Arthritis Center•Sarasota, FL

31d•Onsite

About The Position

The Clinical Research Coordinator (CRC) is responsible for coordinating and conducting clinical research trials within Sarasota Arthritis Center in accordance with study protocols, regulatory requirements, ICH/GCP guidelines, and site standard operating procedures (SOPs). This is a hands-on clinical research role requiring an active Registered Nurse (RN) license, prior Clinical Research Coordinator experience, and IV infusion experience. The CRC works closely with Principal Investigators, study participants, sponsors, Contract Research Organizations (CROs), and the clinical research team to ensure studies are conducted safely, efficiently, accurately, and in compliance with all applicable requirements.

Requirements

Current and unrestricted Registered Nurse (RN) license in the State of Florida.
3+ years of clinical research experience.
Previous professional experience working as a Clinical Research Coordinator (CRC) in clinical trials.
Previous IV infusion experience, including IV placement, medication administration, and patient monitoring.
Clinical experience with blood draws, specimen collection, injections, and other common clinical procedures.
Working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and clinical research requirements.
Experience coordinating clinical trials and working with study protocols, informed consent, source documentation, and regulatory documentation.
Strong organizational skills and exceptional attention to detail.
Ability to manage multiple studies, priorities, deadlines, and participant schedules simultaneously.
Strong clinical judgment and ability to recognize and appropriately escalate participant safety concerns.
Excellent written and verbal communication skills.
Ability to work collaboratively with physicians, research staff, sponsors, CROs, monitors, and study participants.
Proficiency with electronic medical records, electronic data capture systems, and standard computer applications.

Nice To Haves

Clinical research experience in rheumatology, autoimmune disease, infusion therapy, or specialty medicine preferred.
Experience working on pharmaceutical or industry-sponsored clinical trials preferred.
Clinical Research Coordinator certification through ACRP (CCRC) or SoCRA (CCRP) preferred.
Experience with investigational product accountability and administration preferred.
Experience participating in sponsor monitoring visits, audits, and/or regulatory inspections preferred.

Responsibilities

Coordinate assigned clinical research studies from site initiation through study close-out.
Review and interpret study protocols and ensure study activities are conducted in accordance with protocol requirements, IRB requirements, FDA regulations, ICH/GCP guidelines, and site SOPs.
Coordinate and conduct participant study visits according to protocol.
Perform clinical research procedures within the scope of RN licensure and study requirements, including vital signs, blood draws, specimen collection and processing, EKGs, injections, IV placement, and other protocol-specific assessments.
Administer and monitor IV infusions and investigational products as permitted by study protocol, site policy, and applicable regulations.
Monitor participants during and following infusions and other study procedures and appropriately identify, document, and escalate adverse events or changes in clinical status.
Ensure informed consent is appropriately obtained and documented prior to conducting study-related procedures.
Maintain accurate, complete, and timely source documentation and study records.
Enter study data into electronic data capture (EDC) systems and respond to data queries within required timelines.
Coordinate participant scheduling, follow-up visits, laboratory testing, imaging, and other study-related activities.
Monitor participant recruitment and retention and assist with strategies to achieve study enrollment goals.
Ensure study-related equipment is properly maintained, calibrated, and documented as required.
Ensure investigational products are received, stored, handled, administered, and documented in accordance with Good Clinical Practice, applicable regulations, and protocol requirements.
Assist with the preparation, submission, and maintenance of regulatory documents, including IRB submissions, amendments, continuing reviews, and study close-out documentation.
Maintain investigator site files, regulatory binders, delegation logs, training records, and study correspondence.
Maintain required study-specific, GCP, and regulatory training.
Assist with sponsor monitoring visits, audits, and regulatory inspections.
Address monitoring findings and queries promptly and accurately.
Ensure assigned studies remain in a state of inspection readiness.
Report protocol deviations, adverse events, serious adverse events, and other reportable events according to protocol and regulatory requirements.
Serve as a key point of contact for assigned studies with sponsors, CROs, monitors, vendors, and study participants.
Work closely with Principal Investigators and other research team members to ensure appropriate study oversight and timely completion of study activities.
Collaborate with physicians, advanced practice providers, nurses, medical assistants, and administrative staff to integrate research activities into clinical operations.
Maintain clear, professional, and compassionate communication with study participants regarding appointments, study requirements, instructions, and follow-up.
Communicate study concerns, participant safety issues, protocol deviations, and operational challenges promptly to the appropriate Principal Investigator and research leadership.
Participate in feasibility assessments and site qualification activities for potential new clinical trials.
Assist with study start-up activities, including site initiation visits, staff training, and preparation of study materials.
Assist with maintaining and updating Research Department SOPs and processes.
Support accurate tracking of study-related activities, billing, invoicing, and sponsor payments as assigned.
Maintain confidentiality of participant information and comply with HIPAA and all applicable privacy requirements.
Support departmental quality improvement initiatives and other research-related projects as needed.
Other duties as assigned.