Job Req ID: 800481

Position Number: 00142140

Employment Type: Full Time

Shift: Variable/On Call

Shift Details: M-F 8a-5p

Standard Hours: 40.00

Department Name: LCI BMT Administration

Location: Carolinas Medical Center

Location Details:  1021 Morehead Medical Drive Charlotte, NC 28204

Our mission is to improve health, elevate hope and advance healing – for all. The name Atrium Health allows us to grow beyond our current walls and geographical borders to impact as many lives as possible and deliver solutions that help communities thrive. For more information, please visit atriumhealth.org/about-us.

Job Summary
Manages a team and coordinates all aspects of oncology clinical trials. Collaborates with internal groups and externally with trial sponsors, contract research organizations, monitors, auditors, regulatory bodies and others.

Department Specific: As a transplant center research/data manager, you play a critical role in advancing hematopoietic cell transplantation through complete, accurate and timely data submission to Center for International Blood and Marrow Transplant Research (CIBMTR). Your efforts are key in supporting the research that has led to increased survival and an enriched quality of life for thousands of patients.

Essential Functions

• Manages multiple projects and ongoing work activities ensuring work plans and deliverables are met.
• Ensures follow-up on trial subject safety matters as well as regulatory management of trials in their portfolio.
• Allocates resources appropriately to meet departmental needs.
• Recruits; interviews; onboards; trains; mentors and coaches; manages performance; works across teams to collaborate on recruitment process.
• Communicates with teammates and manages remote training/dialogue.
• Assists with training teammates across enterprise as it relates to a specific trial, project, or process.
• Coordinates and manages study subjects; educates subjects and families about research studies, treatments, side effects, and follow-up; ensures subject eligibility for participation in clinical trial, ensures timely and accurate data collection and reporting, maintains appropriate documentation on study subjects, as required by the sponsor and standard practices.
• Assists teammates with start-up, contracting and regulatory process for sponsored projects, develops project-related budgets, tracks project financial performance, time and effort reports, resolution of subject billing issues, and fiscal stewardship of departmental resources.
• Ensures all aspects of the team’s work is accomplished in compliance with accepted Good Clinical Practice (GCP), ICH, OHRP, FDA, corporate and departmental SOPs, and applicable state/federal law.
• Manages safety of research subjects by oversight of adverse event and safety reporting, as well as internal communications to ensure appropriate clinical follow-up.
• Prepares and responds to audit findings and coordinates corrective action plans (CAPA).
• Communicates on-going project status, potential issues, and timelines to investigators, peers and leadership as appropriate.
• Participates in Institute-wide meetings pertaining to area of responsibility (e.g. Section Meetings, Protocol Review, Tumor Board, clinic-based, etc.).
• Assists leadership team in seeking ways to reduce costs and improve processes and efficiency.
• Understands basic scientific methods, biological principles and medical terminology, knowledge of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines, as well as applicable rules/regulations pertaining to research; knowledge of regulatory requirements of the Food and Drug Administration (FDA), Institutional Review Boards (IRB), and Human Subjects Protections (OHRP) pertaining to clinical research.

Department Specific:

• Direct leadership for research/data team.

• Participating in leadership activities, multidisciplinary meetings.

• Liason for CIBMTR and the Transplant Cellular Therapy (TCT) Program.

• Lead TCT Program data inspections and ongoing audits that are performed at all Center for International Blood and Marrow Transplant Research (CIBMTR) Centers.

• Manage corrective action plans, and manage team development and trainings related to CIBMTR.

• These audits ensure the quality and accuracy of the research database by ensuring accuracy and completeness or the data reported to the CIBMTR, identifying system/non-systemic errors, requesting corrective action for errors identified during the audit and providing training to the transplant centers data management staff.

Physical Requirements
Primarily works in an office setting. Requires full range of body motion; sitting for extensive periods of time; walking, standing, reading, and writing/keyboarding. Occasionally lifts and carries items weighing up to 35 pounds. Requires corrected vision and hearing within normal range. Must speak and read/write clearly in English. Must be able to be mobile within the entire healthcare system and other locations that participate in clinical trials.

Education, Experience and Certifications
Bachelor’s Degree required, health/science preferred. Minimum of 3 years clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required; oncology experience strongly preferred. Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.

At Atrium Health, our patients, communities and teammates are at the center of everything we do. Our commitment to diversity and inclusion allows us to deliver care that is superior in quality and compassion across our network of more than 900 care locations.

As a leading, innovative health system, we promote an environment where differences are valued and integrated into our workforce. Our culture of inclusion and cultural competence allows us to achieve our goals and deliver the best possible experience to patients and the communities we serve.

Posting Notes: Not Applicable

Atrium Health is an EOE/AA Employer

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