Clinical Research Coordinator

Clinical Research Coordinator Louisiana Gastroenterology Lafayette, LA Job Details Full-time 18 hours ago Qualifications Microsoft Excel Microsoft Outlook Pharmaceutical regulatory compliance

FDA 21 CFR

Part 11 Phlebotomy specimen handling Research project coordination ICH guidelines Clinical data entry Data entry Research regulatory compliance Clinical quality assurance standards

Documentation Handling Full Job Description Description:

Position Summary We are seeking an experienced Clinical Research Coordinator (CRC) to join our busy gastroenterology practice and support a growing portfolio of industry-sponsored clinical trials. The ideal candidate brings hands-on research experience, strong GCP knowledge, and a patient-centered approach. This is a full-time, on-site position requiring close collaboration with the Principal Investigator, sub-investigators, and sponsor/CRO representatives. The CRC will serve as the operational backbone of the research program—coordinating and conducting participant visits, collecting and entering study data, managing source documentation, and ensuring trial conduct aligns with the protocol and ICH E6(R3) GCP standards. Regulatory and IRB functions are managed by a dedicated department; this role is focused on clinical execution and participant care.

Requirements:

Key Responsibilities Study Conduct & Participant Management Screen, enroll, and schedule study participants in accordance with protocol eligibility criteria. Conduct informed consent discussions and obtain written consent from participants and/or legally authorized representatives. Coordinate and perform study visits, including vital signs, specimen collection (blood, stool, biopsies as applicable), and patient-reported outcome assessments. Perform or arrange phlebotomy for study-required lab draws; willingness to learn phlebotomy required if not currently certified. Administer, dispense, or account for investigational product (IP) as delegated and trained. Assess and document adverse events, protocol deviations, and concomitant medications in a timely, accurate manner. Maintain ongoing participant contact and provide study-related education to enhance retention and compliance. Site Operations & Communication Serve as the primary point of contact for sponsor and CRO representatives on day-to-day study matters. Coordinate with the practice's clinical and administrative staff to integrate research activities into the standard patient care workflow. Assist with budget tracking, invoice preparation, and participant payment/stipend administration as directed. Participate in site initiation visits (SIVs), monitoring visits, investigator meetings, and required GCP training. Maintain working knowledge of multiple concurrent GI protocols (IBD, EoE, NAFLD/NASH, and related indications). Support study start-up activities, including contract review coordination, feasibility assessments, and site qualification preparation. Maintain source documents, case report forms (CRFs/eCRFs), and study files in compliance with ALCOA-C principles and sponsor requirements. Prepare for and participate in sponsor monitoring visits, internal audits, and regulatory inspections; respond to data queries in a timely manner. Support deviation assessment, documentation, and IRB/sponsor reporting workflows. Qualifications Required Minimum 2 years of experience as a Clinical Research Coordinator or in a comparable research role at a clinical site. Working knowledge of Good Clinical Practice (GCP) per ICH E6(R3), 21 CFR Parts 11, 50, 54, 56, and 312. Experience with electronic data capture (EDC) systems and study documentation platforms. Phlebotomy certification or demonstrated willingness and ability to obtain phlebotomy certification within an agreed-upon timeframe after hire. Strong organizational skills with the ability to manage multiple protocols simultaneously without compromising accuracy. Excellent written and verbal communication skills; professional demeanor in interactions with participants, sponsors, and clinical staff. Proficiency in Microsoft Office Suite (Word, Excel, Outlook). Preferred Licensed Practical Nurse (LPN) or Registered Nurse (RN) licensure in the state of Louisiana. ACRP (CCRC or CCRA) or SoCRA (CCRP) certification, or active pursuit thereof. Prior experience in gastroenterology, hepatology, or a related GI specialty. Familiarity with Medidata Rave or other common research platforms/EDCs. Experience supporting sponsor monitoring visits and responding to data queries. Work Environment & Physical Requirements On-site, full-time position at a private GI practice; limited remote work available for administrative tasks only. Regular interaction with patients, including those with chronic GI conditions requiring sensitivity and discretion. Ability to stand for extended periods during clinical procedures; occasional lifting of supplies or equipment (up to 30 lbs). Phlebotomy and specimen handling involving standard biohazard precautions. Occasional extended hours to accommodate protocol-driven visit windows or sponsor visits.