The Clinical Research Manager is responsible for the oversight and conduct of clinical research activities across the organization. Under the administrative direction of the AIU Administrator and clinical direction of the Principal Investigator, this role leads operational, financial, and regulatory aspects of clinical trials. The Manager ensures compliance with Good Clinical Practice (GCP), oversees study staff, and partners cross-functionally to support the advancement of urology-focused research. This position also participates as an active member of the Clinical Research Administrative Committee and contributes to strategic planning and departmental growth.

Primary Duties & Responsibilities:

· Lead end-to-end management of clinical trials, including protocol preparation, CRF development, monitoring plans, and recruitment strategies.

· Source and evaluate clinical studies appropriate to urology practice.

· Develop and implement training programs for Clinical Research Coordinators (CRCs) and staff covering GCP, protocol compliance, documentation, and regulatory practices.

· Ensure all trials comply with GCP through consistent SOP development, staff training, and audit preparedness.

· Supervise site readiness for monitoring visits, audits, and inspections; serve as point of contact and manage responses to findings

· Maintain regulatory documents and clinical trial files per applicable guidelines and ensure timely data entry.

· Collaborate with administration and financial analysts on budgeting, billing, and reconciliation with sponsor payments.

· Coordinate study subject management, including protocol review, inclusion/exclusion validation, and consent accuracy.

· Oversee human resource functions for the research department, including hiring, coaching, and performance support in partnership with Administration and HR.

· Provide regular reports to Administration and the Research Committee on study progress, staffing, compliance, and financial health.

· Ensure compliance with HIPAA, GCP, SOPs, and FDA/state/local regulations.

· Develop and maintain systems to track project status, investigator performance, recruitment metrics, and invoicing.

· Support practice development by creating and maintaining departmental policy and procedure manuals aligned with the market’s clinical research and UUG standards.

· Partner with market clinic leaders to align clinical operations and research goals.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

Qualifications:

Education

· Minimum of LPN or Bachelor’s degree in Nursing or Science-related field required.

· Research certification (e.g., SOCRA or ACRP) preferred; may substitute with equivalent experience.

Experience

· Five (5)+ years of clinical research experience with increasing responsibility in trial coordination, compliance, and operations.

· Proven experience managing clinical trials and teams, preferably in urology or related specialty.

Licensure/Certifications

· IATA Certification for specimen handling, packing, and shipping.

· Certification in Clinical Research preferred.

Knowledge, Competencies & Skills:

· In-depth knowledge of GCP, clinical research regulations, and biomedical ethics.

· Strong leadership and team development skills.

· High attention to detail with proven ability to manage data accuracy, documentation, and regulatory compliance.

· Proficiency in medical terminology, electronic medical records, and clinical trial management systems (CTMS).

· Excellent interpersonal, verbal, and written communication skills; able to interact professionally with physicians, sponsors, auditors, patients, and staff.

· Ability to problem-solve, multi-task, and manage priorities under pressure.

· Skilled in protocol interpretation, consent review, and sponsor communication.

· Strong financial acumen to manage budgets, billing, and contracts.

Direct Reports:

· General supervision of Clinical Research Department staff.

Travel:

· Must have the ability & willingness to travel to other sites as necessary within a geographic region.

Physical Requirements for the Job:

· Work performed in a medical office and clinical research setting.

· Frequent contact with patients, staff, sponsors, and regulatory bodies.

· May be exposed to communicable diseases and biohazards common in clinical settings.

· Requires sitting, walking, standing, bending, and assisting with patient mobility when necessary.

· Must be able to manage high workloads and multiple concurrent deadlines, which may cause occasional stress.