Senior Manager/Supportive Oncology Research - Levine Cancer Institute
Carolinas Healthcare
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Post Date: Nov 15, 2017
Job Type: Full time
Start Date: - n/a -
Salary: - n/a -
Location: US - North Carolina - Charlotte
Job Reference: 145956-en_US
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Job Req ID: 145956Position Number: 00162163Employment Type: Full TimeShift: Variable/On CallShift Details: 1st, M-FStandard Hours: 40.00Department Name: LCI SurvivorshipLocation: Carolinas Medical CenterLocation Details:  Levine Cancer Institute, Charlotte Metro area, with some travel to regional locations   Job Summary
Manages a team and coordinates all aspects of the research strategy in Supportive Oncology and related oncology clinical trials. Collaborates with internal groups and externally with trial sponsors, contract research organizations, monitors, auditors, regulatory bodies, grant-funding organizations, and others. The scope extends to include diverse teams, geographic sites and enterprise initiatives.

Essential Functions  
    Develops, implements, and evaluates the departmental research strategy for Supportive Oncology.Develops, coordinates and facilitates administrative meetings for research production and oversight.Develops policy and procedure for departmental research activities in alignment with LCI/CHS policies.Assists in protocol development, grant-writing, and other activities of investigator-initiated studies.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.
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. Masters Degree preferred. Experience in behavior health research, qualitative research, and/or social science research preferred. Minimum of 5 years clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required; some oncology experience required. Demonstrated people management experience required. Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.  At Carolinas HealthCare System, 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 ApplicableCarolinas HealthCare System is an EOE/AA Employer