Clinical Research Regulatory & Study Start-Up Coordinator

POSITION SUMMARY

Urology Associates, P.C. is seeking a detail-oriented and regulatory-minded Clinical Research Regulatory & Study Start-Up Coordinator to join our growing Clinical Research Department.

This role serves as the department's primary owner of site regulatory compliance and new study activation, ensuring that every clinical trial is initiated correctly, documented thoroughly, and maintained in a state of continuous inspection-readiness throughout its lifecycle. This is a fully on-site role; you will be expected to be available Monday thru Friday.

Working in close collaboration with the Clinical Research Department Manager, Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and external sponsors and Contract Research Organizations (CROs), the Regulatory & Study Start-Up Coordinator ensures that all regulatory submissions, essential document collections, IRB communications, and trial master file activities are executed with accuracy and in strict accordance with ICH E6(R2) Good Clinical Practice (GCP) guidelines, applicable FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and Urology Associates institutional SOPs.

This position plays a critical role in the department's ability to activate studies efficiently and maintain sponsor confidence, audit readiness, and regulatory integrity across a multi-protocol research portfolio.

This role centers on two core functions:

• Regulatory Compliance – ownership and maintenance of all site-level regulatory documentation, IRB submissions, and TMF/eTMF integrity across active and closing protocols.
• Study Start-Up – coordinating the end-to-end site activation process from feasibility through first patient visit, including sponsor document packages, contract and budget support, and site initiation visit (SIV) preparation.

PRIMARY RESPONSIBILITIES

Regulatory Management & Compliance

• Serve as the site's primary regulatory point of contact for all assigned protocols, maintaining a comprehensive understanding of each study's regulatory status and upcoming submission requirements.
• Prepare, submit, and track all IRB submissions including initial applications, continuing reviews, amendments, protocol deviations, unanticipated problems (UAPs), and serious adverse event (SAE) reports in accordance with IRB-required timelines.
• Coordinate the collection, organization, and ongoing maintenance of all essential regulatory documents in the site's electronic Trial Master File (eTMF) using the CRIO eRegulatory platform, ensuring documents are complete, current, and organized per ICH E6 and sponsor requirements.
• Maintain and update the Investigator Site File (ISF) / regulatory binder for each active protocol, including: delegation of authority (DOA) logs, 1572s, financial disclosure forms (FDFs), laboratory certifications and reference ranges, CV and medical license logs for all study personnel, IRB approval letters and correspondence, and protocol and IB version control tracking.
• Prepare and submit required federal regulatory documents including FDA Form 1572, financial disclosure forms, and supporting documentation for IND-associated studies.
• Monitor and track expiration dates for IRB approvals, personnel credentials, lab certifications, and other time-sensitive regulatory documents; initiate renewal processes proactively to prevent lapses.
• Facilitate sponsor and CRO monitoring visits by organizing regulatory files, providing pre-visit document access, responding to document queries, and ensuring all TMF items are audit-ready.
• Conduct routine internal audits of regulatory binders and eTMF files to identify and resolve gaps prior to schedule monitoring visits or sponsor audits.
• Manage and document protocol amendments, updated informed consent form (ICF) versions, and associated re-consent processes in coordination with the IRB and study teams.
• Ensure all study personnel complete required protocol-specific training prior to conducting study activities; maintain training logs and competency documentation.
• Track and document protocol deviations; support the PI in preparing CAPA documentation and deviation reports for submission to the IRB and sponsor.
• Support HIPAA compliance across the research team, including proper handling of protected health information (PHI), authorization forms, and breach documentation procedures.

Study Start-Up & Site Activation

• Lead site-level study start-up activities from feasibility through site initiation, serving as the primary operational driver of new protocol activation.
• Coordinate and prepare the Regulatory Start-Up Package for submission to sponsors and CROs, including all required site qualification and initiation documents (e.g., FDA 1572, financial disclosures, CVs, licenses, lab certifications, IRB submissions).
• Submit initial IRB applications and supporting documents (protocol, investigator brochure, ICF drafts, recruitment materials, HIPAA authorization forms) and manage IRB correspondence through to full approval.
• Track and manage all start-up milestones and timelines using department tools (CRIO, CTMS), providing regular status updates to the Department Manager.
• Collaborate with the Department Manager and legal/contracts team to support contract and budget review and signature workflows; track CTA/SIA execution status.
• Establish and organize new regulatory binders and eTMF structures upon study activation, ensuring all required documents are filed prior to first patient contact.
• Prepare and distribute Site Initiation Visit (SIV) materials; attend SIVs and serve as the site's regulatory representative during sponsor-led activation visits.
• Coordinate site qualification visits (SQVs) and pre-study site assessments, ensuring required documentation and personnel are available and that the site presents a state of readiness.
• Compile and submit sponsor-required pre-enrollment documentation packages, including all protocol-specific training attestations, signature pages, and site authorization forms.
• Establish and distribute the Schedule of Events (SOE) and study procedure overviews to relevant clinical staff as part of site activation onboarding.
• Work with the PI and CRCs to confirm inclusion/exclusion criteria comprehension and pre-screening readiness prior to the first patient visit.

Cross-Functional & Departmental Support

• Collaborate with study CRCs to provide seamless handoff from start-up/activation to active trial conduct, ensuring continuity of regulatory documentation.
• Serve as an internal resource and subject matter expert on regulatory requirements and documentation standards; provide guidance and on-the-job coaching to CRC team members.
• Participate in department meetings, sponsor calls, and CRO communications as the regulatory representative for assigned protocols.
• Assist in the development and maintenance of departmental SOPs and regulatory templates, contributing to continuous improvement of clinical research operations.
• Support study close-out activities including final TMF reconciliation, archiving, and regulatory document completion for assigned protocols.
• Maintain awareness of evolving FDA, ICH, and IRB regulatory requirements and communicate relevant updates to the department.

QUALIFICATIONS

Education

• Bachelor’s degree in a life sciences, health sciences, nursing, or a related field preferred.
• Associate’s degree with commensurate clinical research experience will be considered.

Required Experience & Knowledge

• Minimum 1 -2 years of experience in clinical research, regulatory coordination, or a closely related role.
• Working knowledge of ICH E6 (R2) Good Clinical Practice (GCP) principles and FDA regulations governing clinical trials (21 CFR Parts 50, 56, 312, 812).
• Experience with IRB submission processes, including initial submissions, continuing reviews, amendments, and AE/SAE reporting.
• Familiarity with study start-up processes including site qualification, regulatory document package assembly, and IRB/sponsor document workflows.
• Experience organizing and maintaining regulatory binders, Trial Master Files (TMF), or electronic document management systems.
• Familiarity with informed consent processes and HIPAA requirements in a research setting.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and comfort learning new clinical software platforms (e.g., CRIO, Redcap, or equivalent).

Preferred Experience

• Experience with CRIO or a comparable eRegulatory/eTMF platform.
• Prior work in a urology, oncology, or multi-specialty clinical research setting.
• Experience with FDA Form 1572, financial disclosure forms, and IND-related submissions.
• Familiarity with CTMS platforms and research operations workflows.
• Experience supporting monitoring visits (site initiation, routine monitoring, close-out).

Certifications (Preferred, Not Required)

Clinical research certifications are viewed favorably and reflect a commitment to professional development in the field.

Applicable certifications include, but are not limited to:

• ACRP Certified Clinical Research Coordinator (CCRC)
• SOCRA Certified Clinical Research Professional (CCRP)
• NIH Good Clinical Practice (GCP) Training
• CITI Program – GCP for Clinical Trials (Human Subjects Research)
• IATA Dangerous Goods Training (if applicable to protocol-specific specimen shipment)

CORE COMPETENCIES

Regulatory & Compliance Acumen

• Deep understanding of GCP, FDA, and IRB requirements with the discipline to apply them consistently across a multi-study portfolio.

Exceptional Attention to Detail

• Ability to manage complex document sets with precision, catching errors and version discrepancies before they become findings.

Organizational Mastery

• Ability to independently manage multiple simultaneous study timelines, submission deadlines, and document workflows without sacrificing quality.

Clear & Professional Communication

• Confident communicator with sponsors, CROs, IRB offices, and internal team members; skilled at written correspondence and documentation.

Proactive Problem-Solving

• Anticipates regulatory gaps and start-up bottlenecks before they cause delays; brings solutions, not just problems, to the department.

Commitment to Continuous Learning

• Actively stays current on regulatory updates, GCP developments, and industry best practices; pursues professional growth in clinical research.

WORKING CONDITIONS

This position is primarily on-site at Urology Associates, P.C. in Nashville, TN. Standard office/clinical research environment. Occasional evening or modified schedule may be required to accommodate site initiation visits, monitoring visits, or audit preparation activities. The role requires prolonged periods of computer work and document review.

WHY JOIN UROLOGY ASSOCIATES CLINICAL RESEARCH

Urology Associates, P.C. is one of the region’s leading urology practices, with an active and growing clinical research portfolio spanning device, pharmaceutical, and investigator-initiated trials. Our Clinical Research Department is undergoing a period of intentional investment – adding dedicated regulatory infrastructure, implementing modern eSource and eRegulatory platforms (CRIO), and building a team designed to scale. This is an opportunity to grow with the department, develop specialized expertise in regulatory coordination and study start-up, and contribute meaningfully to research that advances urological care.

To Apply

Interested candidates should submit a resume and cover letter outlining their clinical research experience, regulatory background, and interest in this role. Urology Associates, P.C. is an Equal Opportunity Employer.

UA offers an exceptional benefits package, including:

• Company-Paid Holidays
• Vacation and Sick Time
• PTO (16 hrs. annually)
• Medical, Dental and Vision Insurance
• Basic Life Insurance: Company-paid
• Long-Term Disability Insurance: Company-paid
• Optional Short-Term Disability
• Optional Additional Life Insurance: For employees and/or family members
• Health Savings Account Options: Including employer contributions
• Retirement Benefits: Approximately 8% profit-sharing contribution to your retirement account
• Employee Assistance Program: Mental health benefits through The Hartford: Company-paid