Regional Manager, Clinical Research (32366)

About the role

The Regional Clinical Research Manager is responsible for the coordination and administration of clinical trials at 3–4 clinical research site locations within a designated region under the direction of the VP of Operations and Director of Research Strategy and Operations. They oversee clinical research staff to ensure successful trial conduct and compliance with established regulations and standards.

Job relationships

Reports directly to the Director of Strategy and Operations and indirectly to Urology America leadership. This role interfaces with individual market presidents, Principal Investigators, physician partners, clinical providers, local vendors, site staff, clinic patient navigators, IT, and data management.

Role qualifications

• Minimum of five years conducting clinical trials
• Urology-based clinical research experience highly preferred
• Prior leadership experience within an organization
• Bachelor’s degree in a health or science field preferred
• Experience overseeing and conducting pharmaceutical and device study protocols
• Knowledge of and experience with Good Clinical Practices (GCPs) and relevant federal and state regulatory guidelines
• Proficiency in Microsoft Office Suite, EMR, Practice Management, Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS)
• Exceptional time management and prioritization skills
• Excellent communication skills with all levels of management, staff, sponsors, and providers

Essential job responsibilities

• Build and manage research departments across assigned locations and markets in scope, size, reputation, and professionalism
• Lead research department staff by conducting training, assigning responsibilities, supporting hiring, and managing annual reviews
• Provide oversight and support of Clinical Research Coordinators (CRCs) in all markets
• Assist with patient recruitment, protocol review, feasibility documents, trial set-up and launch, site qualification, initiation, monitoring, and audit visits
• Maintain relevant certifications and continually update knowledge of FDA, GCP, ICH, federal and state regulations
• Work with the IRB/Recruitment Specialist to ensure timely submissions, updates, and close-outs
• Maintain accurate and complete documentation including regulatory files, informed consent forms, source documentation, drug dispensing logs, subject logs, and study-related communications
• Design, implement, and manage workflow systems for all clinical research activities
• Use EMR and data management systems to complete/monitor EDC, eCRFs, adverse event documentation, maintain patient records, and create patient recruitment strategies
• Assist CRCs with identification and prompt reporting of protocol deviations, adverse events, and serious adverse events per protocol, IRB, and/or sponsor requirements
• Collaborate with IRB, study sponsors, Principal Investigators, and Sub-Investigators; attend necessary meetings and calls
• Provide continuous communication on study conduct from pre-study through post-study to all relevant stakeholders
• Monitor invoicing, billing, and payments with the finance department to ensure timely and accurate accounts receivable processes
• Create, review, and maintain staff CVs and certifications
• Evaluate, purchase, and maintain necessary equipment and perform equipment monitoring
• Participate in site visits, site initiation visits, monitoring, and FDA inspections
• Support CRCs in screening, consenting, history taking, exams including EKG, blood draw, vitals, and procedure visits
• Complete study close-out steps and documentation
• Communicate with and support patients and their families as necessary
• Maintain HIPAA-compliant communication and confidentiality at all times
• Act as primary liaison to local market clinics and research departments

Performance requirements

Knowledge

• Clinical research in a specialty setting
• Medical practice clinical and administrative systems
• Clinical research software and sponsor requirements for successful trial completion
• Medical terminology

Skills

• Proficiency with multi-line phone systems and relevant computer systems
• Strong interpersonal and communication skills with internal staff and external customers
• Ability to evaluate and implement study protocols and budgets
• Skill in reading medical chart terminology
• Time management

Abilities

• Effective communication with patients, staff, and external contacts by phone, in person, and email
• Elicit appropriate patient information for clinic staff
• Read and understand written information and ideas
• Apply general rules to specific problems to produce logical answers (deductive reasoning)

Travel

25–50% travel to assigned regional sites.

Reporting line

CRC/Operations Leads, Clinical Research Coordinators, Clinical Research Assistants, Interns, and other research staff as the department grows.

Physical demands and work environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Physical demands: Sitting approximately 70–90% of the day; walking or standing for the remainder. May require stooping, bending, mobility for patient study visits, and lifting up to 25 pounds.
• Work environment: Primarily office setting with time in clinical settings for patient study visits. Moderate noise level in a clean, well-lit office/clinical environment. Travel required between Urology Austin clinical locations and outside Ambulatory Surgery Centers to meet study demands.