The Director of Clinical Operations ensures that all clinical research studies conducted at the company’s Clinical Pharmacology Research Unit (EPCU) are performed in compliance with all sponsor protocols, Good Clinical Practices (GCPs), EPCU Standard Operating Procedures (SOPs), and any other applicable regulations. The Director of Clinical Operations will also ensure that all clinical operations work product is timely, efficient, and of the highest quality. Liaison with other departments to ensure that the highest quality on the unit is maintained.
- Possesses thorough knowledge of all current study protocols.
- Meets regularly with Managers to discuss staffing for upcoming studies, sharing of staff between departments, and overtime reports.
- Authorizes all hiring, transfers, performance reviews, increases, and terminations in the Department in conjunction with the Director, Clinical Operations.
- Leads departmental meetings regularly as appropriate.
- Performs and assists in client pre-site, site and audit assessments for the Early Phase Units.
- Provides assistance in creating study budgets, contracts and completion of site questionnaires.
- Establishes and maintains relationships with clients, vendors, and hospital representatives.
- Reviews, tracks and approves all Departmental expenses.
- Works closely with Project Management and Feasibility groups in drafting timelines for studies.
- Works in conjunction with Clinical Operations Managers in managing all aspects of departmental performance improvement strategies including identifying areas for improvement, developing an action plan in conjunction with all affected areas/staff, and tracking and reporting results to Senior Management.
- Interfaces with key departments to discuss status of current studies at the company, as well as significant staffing, hospital issues.
- Explores potential in upcoming studies, methods to continue to provide sponsors with the highest quality data, increasing clinic efficiency and directions for future growth.
- Provides clinical input on protocols in development. Identifies which protocols can or cannot be done feasibly/profitably at the company.
- Manages all aspects of clinical operations at the unit.
- Supervises additional support staff and ancillary staff as required by the unit.
- Evaluates proposed protocols and provides feedback to Business Operations on clinical feasibility.
- Provides information to Business Operations/Business Development to complete proposals/budgets as appropriate.
- Provides continued contact with the Sponsor for duration of the clinical study including entertaining Sponsor during site visits.
- Devises and modifies staff training programs in conjunction with the Director, Clinical Operations.
- Reviews, tracks and approves all Departmental expenses as appropriate.
- Works closely with Advertising/Enrollment Departments on recruitment strategy/issues as appropriate.
- Reviews Draft consents and offers suggestions to Regulatory Compliance.
- Determines the necessity for the creation of departmental Clinical Operating Guidelines (COGs) and Standard Operating Procedures (SOPs) to meet hospital/facility requirements.
- Oversees and approves the review, revision, and/or retirement of departmental COGs and SOPs, upon approval, oversees the training and implementation of departmental and inter-departmental COGs/SOPs.
- Maintains and updates knowledge of Good Clinical Practices (GCPs)/Good Documentation Practices (GDPs) and their proper application. Reinforces the use of GCPs/GDPs departmentally through example and staff training.
- All other duties as assigned.
- Demonstrated leadership ability.
- Meticulous attention to detail.
- Strong interpersonal, written/verbal communication and organizational skills.
- Ability to effectively manage time, manage resources and multi-task.
- Computer proficiency.
- Local and out-of-town travel.
- Flexible schedule.
Knowledge and Experience:
- 3-5 years clinical research and management experience.
- Previous early phase clinical trial experience and BS/MS in a related science.
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything