Clinical Research RN / Study Coordinator

Clinical Research RN / Study Coordinator Position Type: Full-Time Location: Houston, Texas | On-Site Department: Clinical Research Reports To: Director of Research Position Overview CrofootMD Clinic and Research Center is seeking an experienced Registered Nurse (RN) with a strong background in clinical research coordination to join our growing research team. This is primarily a Clinical Research Study Coordinator position with additional nursing responsibilities, rather than a traditional research nursing position. The selected candidate will be responsible for independently managing assigned clinical trials, coordinating participant care and study visits, maintaining research documentation, and ensuring compliance with study protocols and regulatory requirements. As a licensed RN, the candidate will also perform protocol-required nursing procedures, including specimen collection, medication and investigational product administration, participant assessments within their nursing scope of practice, and other delegated clinical responsibilities. The ideal candidate will have demonstrated experience serving as the primary coordinator for multiple clinical trials and be capable of assuming responsibility for ongoing studies or newly initiated studies following required protocol-specific training and orientation. Our clinical research program focuses primarily on HIV, infectious diseases, investigational treatments, and vaccines. We conduct multiple clinical trials simultaneously and are seeking a qualified professional who can independently coordinate assigned studies, manage participant visits, and maintain compliance with study protocols, sponsor requirements, and applicable regulatory standards. Essential Duties and Responsibilities Clinical Trial Coordination and Management Independently coordinate and manage multiple assigned clinical research studies from startup through closeout. Assume responsibility for ongoing studies, including reviewing existing study documentation, participant status, pending activities, and upcoming protocol requirements. Review and interpret study protocols, schedules of assessments, investigator brochures, and other study-related documents. Coordinate study startup activities, including site initiation visits, required training, regulatory documentation, and study-specific preparations. Develop and maintain participant visit schedules, ensuring protocol-required procedures are completed within established visit windows. Track enrollment goals, participant status, study milestones, and outstanding study activities. Maintain timely, accurate, and complete study documentation in accordance with applicable regulations, ICH-GCP guidelines, and sponsor requirements. Identify, document, and promptly elevate protocol deviations, participant safety concerns, and other study-related issues. Serve as a primary point of contact for assigned studies with sponsors, Clinical Research Associates (CRAs), CROs, and internal research personnel. Prepare for and actively participate in monitoring visits, audits, and inspections, including timely resolution of findings and action items. Participant Recruitment and Clinical Care Recruit, prescreen, screen, and enroll eligible participants in accordance with study protocols and IRB-approved procedures. Conduct and document the informed consent process as authorized and delegated by the Principal Investigator. Coordinate participant appointments, follow-up visits, and retention activities. Obtain and document medical histories, vital signs, and other protocol-required clinical information. Perform nursing procedures within the scope of RN licensure and delegated study responsibilities, including venipuncture, specimen collection, medication administration, and investigational product administration. Administer investigational treatments, vaccines, and other study medications in accordance with protocol requirements, applicable policies, and authorized delegation. Monitor participants for adverse events and changes in clinical condition, documenting findings and promptly communicating concerns to the Principal Investigator or delegated provider. Provide participant education regarding study procedures, medication instructions, potential side effects, and reporting requirements. Maintain a professional, welcoming, confidential, and respectful environment for participants from diverse backgrounds. Research Documentation and Regulatory Compliance Maintain accurate, complete, and contemporaneous source documentation for all assigned studies. Enter and review study data in Electronic Data Capture (EDC) systems and respond to data queries within required timelines. Maintain participant records, study logs, and required documentation within electronic and paper-based research systems. Assist with regulatory submissions, protocol amendments, continuing reviews, and other IRB-related documentation. Ensure adherence to ICH-GCP, HIPAA, institutional policies, and applicable federal and state regulations. Maintain accurate documentation of investigational product administration, accountability activities, and other delegated study responsibilities. Support continuous inspection readiness through proactive documentation review and resolution of outstanding items. Laboratory and Specimen Management Collect, process, package, and prepare biological specimens for shipment according to protocol-specific laboratory manuals and applicable safety requirements. Ensure proper specimen identification, handling, storage, and chain-of-custody documentation. Coordinate specimen shipments in accordance with applicable IATA requirements. Maintain laboratory supplies, specimen collection materials, and study-specific equipment as assigned. Team Collaboration and Operational Support Collaborate closely with investigators, research nurses, study coordinators, clinical staff, and administrative personnel to ensure efficient study operations. Communicate participant needs, study updates, upcoming visits, and outstanding responsibilities to appropriate team members. Assist with onboarding, mentoring, and training research personnel as appropriate. Maintain organized clinical research workspaces and ensure adequate study-related supplies. Demonstrate accountability, initiative, professionalism, and the ability to manage competing priorities. Perform additional research-related responsibilities as assigned by the Director of Research or designee. Required Qualifications Education and Licensure Associate Degree in Nursing (ADN) or Bachelor of Science in Nursing (BSN) from an accredited nursing program. Current, active, and unrestricted Registered Nurse (RN) license issued by the Texas Board of Nursing or a valid multistate license authorizing practice in Texas. Professional Experience Minimum of 3 years of direct clinical research coordination experience, including responsibility for participant visits, study documentation, and protocol execution. Demonstrated experience independently coordinating clinical trials and managing multiple concurrent studies. Experience working directly with sponsors, CROs, CRAs, and Principal Investigators. Experience with informed consent, participant recruitment, adverse event documentation, protocol deviations, and regulatory compliance. Experience with electronic data capture systems, electronic medical records, and clinical trial management systems. Required Certifications Candidates must possess current certifications or documented training in: Good Clinical Practice (GCP) Human Subjects Protection (HSP) / Human Research Protection (HRP) IATA Dangerous Goods Training applicable to biological specimen shipments Required Skills and Competencies Strong understanding of clinical research operations and ICH-GCP requirements. Ability to independently prioritize responsibilities and manage multiple studies simultaneously. Excellent documentation, organization, time management, and problem-solving skills. Strong verbal and written communication skills. Proficiency with Microsoft Office applications, including Outlook, Teams, Word, and Excel. Ability to work effectively with individuals from diverse backgrounds, including diverse gender identities, sexual orientations, cultures, and communities. Demonstrated professionalism, reliability, accountability, and commitment to participant safety and research integrity. Preferred Qualifications Bachelor of Science in Nursing (BSN). Current Certified Clinical Research Coordinator (CCRC) certification through ACRP or Certified Clinical Research Professional (CCRP) certification through SOCRA. Experience coordinating HIV, infectious disease, vaccine, or investigational therapeutic clinical trials. Experience with Phase I–IV interventional clinical research. Bilingual proficiency in English and Spanish, including the ability to communicate effectively with Spanish-speaking participants. Experience with RealTime CTMS, Veeva SiteVault, eClinicalWorks, and electronic informed consent systems. Familiarity with Interactive Response Technology (IRT/IWRS), electronic Clinical Outcome Assessment (eCOA), and investigational product accountability processes. Experience transitioning into existing studies and independently managing established participant cohorts. Work Schedule and Expectations Full-time (40hrs/week), primarily on-site position in Houston, Texas. Standard work schedule established by the research department. Occasional early morning, evening, or weekend availability may be required based on protocol-specific procedures, participant needs, or study requirements. Must be able to maintain assigned work schedules, meet study deadlines, and provide dependable coverage for research activities. Benefits Medical, dental, and vision insurance options. Participation in the company's 401(k) retirement plan, subject to plan eligibility requirements. About CrofootMD CrofootMD Clinic and Research Center is a Houston-based healthcare and clinical research organization dedicated to advancing medical care through clinical research, with a particular emphasis on HIV, infectious diseases, and emerging treatment options. We are committed to delivering high-quality participant care, maintaining rigorous research standards, and fostering a welcoming and inclusive environment for the diverse communities we serve. Join our research team and play an important role in advancing innovative treatments while making a meaningful difference in the lives of research participants. #J-18808-Ljbffr Gordon Crofoot MD, PA