Manager, Research Operations

OneOncology•Chattanooga, TN

15d

About The Position

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.

Requirements

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
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.)

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