Manager, Research Operations

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

The Research Operations Manager ensures the integrity and quality of clinical trials are maintained and conducted in accordance with international, federal, state, and local regulations, and Institutional Review Board (IRB) approvals. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. Work is performed under the general direction of the Senior Director of Research Operations and principal investigators.

Essential Duties and Responsibilities

• Supervise research coordinators, across multiple sites, by managing their workload and optimizing performance while ensuring regulatory compliance
• Collaborate with others to design and rollout new or improved workflows and standard operating procedures.
• Manage site qualification and site initiation visits with sponsors for clinical trial implementation
• Reviews protocol leads for feasibility specific to resources required to carry out protocol e.g. patient population, staff, equipment, etc.
• Assure that protocols and associated budgets are loaded into CTMS platform in a timely manner
• Reviews new protocols and associated consent forms with direct reports to ensure in-depth understanding method of action, schedule of events, adverse events etc.
• Supervises direct reports in the screening of potential subjects for clinical trials through a careful review of the patient’s past medical history and a review of current findings against protocol-specific inclusion and exclusion criteria
• Oversees, across multiple sites, compliance of all research patient visits including testing and procedures per sponsor protocol
• Oversees the maintenance of medication inventory and reconciliation
• Assures direct reports complete accurate and timely data collection, documentation, entry, and reporting in both sponsor and Tennessee Oncology databases and that this complies with sponsor protocol requirements, regulations, and department policies across multiple sites
• Liaise with sponsor monitors regarding protocol questions and/or clarifications
• Communicates with patient, principal investigator, outside physicians, regulatory staff, and sponsor regarding serious adverse events including proper documentation and follow-up
• Reviews protocol, amendments, notices, suspensions and terminations with direct reports
• Liaises with sponsor staff such as study monitors and assists direct reports in the preparation for and completion of monitor visits
• Prepares for and attends sponsor and FDA audits
• Act as a resource for direct reports regarding clinical trial protocols, particularly the proper administration and expected side effects of the investigational product
• Supervises the procurement, processing, and shipping of biospecimens per sponsor protocol and regulations
• Serves as a liaison to multiple Tennessee Oncology departments, providers, and other team members regarding research protocols and regulatory compliance with particular attention to quality and optimizing workflows
• Protects the rights, safety and welfare of patients

• Departmental supply monitoring and ordering
• Conduct trial feasibility and patient screening for enrollment as necessary
• Travel to all research site offices as necessary
• Maintains a professional approach respecting the dignity and confidentiality of patients
• Maintains a good attendance record and reports to work on time
• Maintains a professional attitude and appearance
• Maintain NYS licensure as applicable
• Performs other duties as assigned

EDUCATION AND EXPERIENCE

• Bachelor’s degree in biology, life sciences or nursing preferred
• 5+ years’ work experience in pharmaceutical, clinical office or research space.
• Previous supervisory experience preferred

REQUIRED KNOWLEDGE, SKILLS & ABILITITES

• Excellent verbal and written communication skills
• Excellent organization and follow-up skills
• Ability to handle multiple priorities in a fast-paced environment
• Ability to understand complex clinical trials protocols
• Ability to oversee and guide multi-functional teams
• Microsoft Office product knowledge (Word, Excel, PowerPoint, etc.)