Job Description
Job title: Lead Clinical Research Coordinator Premier Research Center (PRC) is an exciting and rapidly growing clinical research group. We have been doing clinical research since 2015, initially as Tennessee Comprehensive Lung and Sleep Center. PRC has extensive experience doing phase 2-4 clinical trials in pulmonary diseases such as asthma, COPD, ILD and bronchiectasis with plans to expand into phase 1 studies and internal medicine trials such as diabetes, hypertension and lipid studies.
Responsibilities:
Lead Clinical Research Coordinator responsibilities center on leading clinical trials, ensuring regulatory compliance, and coordinating cross‑functional research activities. Below is a consolidated job description. Core Clinical Trial Oversight oversee clinical trials and research projects, ensuring studies follow approved protocols and timelines. maintain research protocols including amendments help manage day‑to‑day clinical trial operations, including site activities, monitoring, and study documentation. Lead end‑to‑end operational planning for Phase I-IV trials, including resource allocation and milestone tracking. Regulatory & Compliance Responsibilities Ensure compliance with GCP, FDA, ICH, and institutional regulations across all study activities. Oversee adherence to SOPs and regulatory standards during monitoring and trial administration. Data Management & Reporting Oversee collection, analysis, and interpretation of clinical data, ensuring accuracy and timely reporting. Maintain accurate study records, including progress reports, data logs, and documentation for audits. Team Leadership & Collaboration Assist PI/sub I lead and manage clinical research staff, providing training, mentorship, and performance oversight. Along with PI/sub I, serve as a contact for study sites, CROs, and vendors, ensuring smooth operational execution. Assist PI/Sub I with study and patient recruitment strategy as well as execution. Oversee study initiation, monitoring, and close‑out activities, ensuring protocol adherence. Budgeting & Strategic Planning Assist with PI/Sub I develop and manage study budgets, ensuring cost control and alignment with project goals. Participate in strategic planning, including annual clinical operations planning and resource forecasting. Lead Clinical Research Coordinator Qualifications & Skills BSN/RN/MSN
(Preferred, but not required) Certification in clinical research (e.g., CCRA, CCRP). Extensive experience in clinical trial management and strong project management skills. Proficiency in regulatory and ethical guidelines. Excellent communication and interpersonal skills and the ability to manage and mentor research teams. Experience with budget management and financial oversight (preferred but not required) Minimum of 4 years of experience in clinical research to include hands-on experience Extensive knowledge of regulatory requirements, including FDA regulations and ICH-GCP guidelines. Excellent organizational and project management abilities with attention to detail. Proficient in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems. Exceptional communication and interpersonal skills Proven track record of successful study execution, including meeting enrollment targets and timelines. Ability to balance multiple priorities, work under pressure, and adapt to changing priorities and deadlines. Job Type Full-time Compensation:
Excellent compensation package commensurate with experience Relocation assistance Why Join Us? Opportunity to lead and grow an expanding clinical research department Work closely with experienced pulmonary and sleep medicine specialists Collaborative, patient-centered environment Meaningful work that contributes to advancements in respiratory healthcare Convenient Hendersonville location near Nashville Apply Today For immediate consideration, please submit your resume and optional cover letter to: Attn:
Clyde Southwell, MD Fax:
615-824-0157 Job Type:
Full-time Pay:
From $65,000.00 per year Benefits:
401(k) Dental insurance Flexible spending account Health insurance Life insurance Paid time off Retirement plan Vision insurance License/Certification:
RN License IN TN (Required) Ability to Commute:
Hendersonville, TN 37075 (Required) Ability to Relocate:
Hendersonville, TN 37075: Relocate before starting work (Required) Work Location:
In person
