Clinical Trial Specialist II

Astera Cancer Care; Nashville (TN); On-site; USD 60,000 - 90,000; Full time

Job summary

Tennessee Oncology is seeking a dedicated research operations professional to support the coordination and conduct of Phase I–IV clinical trials. You will ensure protocol integrity, consent maintenance, and regulatory compliance across multidisciplinary teams.

Responsibilities include monitoring visits, data updates, and collaboration with research nurses, sponsors, and site personnel to ensure timely trial progress at multiple Nashville locations.

Qualifications

• Bachelor’s Degree or equivalent combination of education and experience required.

Responsibilities

• Manage and execute day-to-day operations of Phase I–IV clinical research protocols in compliance with GCP/ICH guidelines and regulatory requirements.

Skills

GCP/ICH guidelines

Microsoft Office

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s Degree or equivalent

Tools

SharePoint

OneNote

Job 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. Established 1976 in Nashville, Tennessee Oncology’s mission remains unchanged: 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.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) 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 VisitsCoordinate 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 trialProvides regular and concise updates on study timelines, patient statuses, and trial details to study teams, Principal Investigator, and study sponsorsMeets data management deadlines set by internal and external teamsActs 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 PracticeServes 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 resolutionTaking on more complex and divergent clinical trial protocolsDevelops study tools to aid in onboarding and department process improvementActs as a preceptor and resource to new colleaguesEngages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.KNOWLEDGE, 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 required2-3 years of experience working in clinical trials required