Job Description:Responsible for the efficient management of clinical trial coordinators (CRCs) of the Research Department. Provides in-depth knowledge, expertise, ongoing support, education, and training to CRCs regarding the conduct of clinical research studies. Guides CRC staff, setting and communicating priorities and performance standards. Stays up to date with new and revised standard operating procedures and regulations. Works with departmental leadership to align training and staff development, implementing new training programs to meet emerging/unmet needs.
ESSENTIAL FUNCTIONS:Efficiently manages all regulatory aspects of the Research Department. Provides expertise and leadership in the development, preparation, and implementation of regulatory strategies to support clinical research missions.
- Screen potential subjects for clinical trials through a careful review of the patient's past medical history and a review of current findings against inclusion and exclusion criteria specific to a trial
- Obtain and maintains informed consents of each patient for the duration of a study
- Coordinate all patient visits including testing and procedures as per sponsor protocol
- Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Tennessee Oncology databases while complying with sponsor protocol requirements, regulations, and department policies
- Communicates with principal investigator, outside physicians, regulatory staff, and sponsor regarding serious adverse events including proper documentation and follow-up
- Serves as preceptor for new research staff members
- Maintains regulatory documents in accordance with department policies and regulations
- Liaises with sponsor staff such as study monitors and prepares, and attends monitor visits
- Prepares for and attends sponsor and FDA audits
- Procures, processes, and ships biospecimens per sponsor protocol and regulations.
- Protects the rights, safety, and welfare of patients
- Strives to maintain harmonious relationships with clinic personnel, administrative staff, patients, their caregivers, and the public
- Reviews newly activated protocols, amendments, notices, suspensions, and terminations.
- Responsible for maintaining current knowledge of the Code of Federal Regulations and International Council for Harmonization Guidelines
- Maintains required certification in Good Clinical Practice, Human Subjects Protections, and biological shipping training
- Serves as a liaison to multiple Tennessee Oncology departments, providers, and other personnel regarding research protocols and regulatory compliance
- 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
- Maintains Tennessee licensure as applicable
- Performs other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES:- 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 function in multi-functional teams
- Microsoft Office product knowledge (Word, Excel, PowerPoint, etc.)
- Bilingual (English/Spanish) a plus
EDUCATION & EXPERIENCE:- Bachelor's Degree or equivalent combination of education and experience required
- Four years of relevant experience required
- Certification in clinical research coordination from ACRP or SOCRA preferred
