Clinical Trial Specialist - Nashville, United States - Tennessee Oncology
Description
Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country.
To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home.
Our growing network of physicians and locations is based on this mission.Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient.
We believe caring for cancer patients is a privilege.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.
Job Description:
This position works closely with the research team to help coordinate the approval processes and conduct of research protocols, assured that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, GHCR policies and procedures, and research protocols.
The Clinical Trial Specialist I will assist in the management of subjects on clinical trials and coordinating activities associated with clinical trials under the mentorship and guidance of a Clinical Trial Specialist II.
ESSENTIAL FUNCTIONS:
Manage and execute the day-to-day operations of complex Phase I-IV clinical research protocols in compliance with applicable GCP/ICH guidelines and other regulatory requirementsManage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) in order to accurately coordinate clinical study activity.
Provides second check for patient eligibility to clinical trial, following review by research nurse, including a second check of inclusion/exclusion requirements and eligibility criteriaAttend and oversee Site Initiation Visits Coordinate and attend regular monitoring visits and closeout visitsMaintains informed consents records of each patient for the duration of a studyMaintains and files all relevant study documents throughout lifetime of a trial Provides regular and concise updates on study timelines, patient statuses, and trial details to study teams, Principal Investigator, and study sponsor.
Meets data management deadlines set by internal and external teams Acts as a point of contact for Research Data Coordinator, and assists with and reviews data entry where necessaryProtects the rights, safety, and welfare of patientsStrives to maintain harmonious relationships with clinic personnel, clients, and administrative staffReviews newly activated protocols, amendments, notices, suspensions, and terminationsMaintains required certification in Good Clinical Practice and Good Documentation Practice Serves as a liaison to multiple Tennessee Oncology departments, providers, and other personnelServes as a liaison between GHCR and external clients and sponsorsMaintains a professional approach respecting the dignity and confidentiality of patientsMaintains a good attendance record and reports to work on timeMaintains a professional attitude and appearanceProactively identifies trial-related issues and provides recommendations for resolutionExecutes job responsibilities with the understanding of how output would affect, and impact other areas related to own job area/team with occasional guidanceKNOWLEDGE, SKILLS &ABILITIES:
Ability to independently handle multiple priorities in a fast-paced environmentAbility to comprehend complex clinical trial protocolsMicrosoft Office product knowledge (Word, Excel, PowerPoint, SharePoint and OneNote)EDUCATION &
EXPERIENCE:
Bachelor's Degree or equivalent combination of education and experience requiredOne year of experience working in clinical trials required