Research Project Manager
Hollings Cancer Center, Medical University of South Carolina
February 16, 2022
Research Project Manager
MUSC Health Florence
This position will serve as the Research Project Manager to develop and support a clinical research program at MUSC Health Florence. This position will be responsible for leading the development of a sustainable operational and financial research model to conduct clinical research studies at MUSC-Florence in collaboration with MUSC Health Florence leadership and MUSC South Carolina Clinical & Translational Research Institute (SCTR). In addition, this position will provide research coordinator services to support studies conducted at MUSC Health Florence and will hire and supervise additional research coordinators and other staff as required to support research at MUSC Health Florence.
Bachelor’s degree in health-related science preferred.
Knowledge of laws, regulations, and policies and procedures relevant to the conduct of clinical trials is preferred. Applicant must be able to exercise judgment and discretion and to establish and maintain effective working relationships. Must be able to work collaboratively, respectfully, and appropriately with investigators, research staff, and clinical staff across campus. Certified Clinical Research Professional or Certified Clinical Research Associate (certified by the Society of Clinical Research Associates, Inc (SOCRA) or the Association of Clinical Research Professionals (ACRP) is preferred.
Ability to work with minimal supervision and function independently on a daily basis. Applicant will be directly supervised by MUSC Health Florence [LEADERSHIP]. Candidate must be willing to work flexible hours and must be able to work overtime if required. Occasional overnight and local area travel may be required.
Candidates are required to be proficient in Windows and MS Office Suite. Strong organizational and problem-solving skills are required. Applicant must be versatile with respect to changing workplace demands. Previous healthcare experience is required and previous research experience is preferred including experience with research coordination, budget development, and regulatory management.
Program Development and Oversight – 40%
1. Engage in strategic planning and program development with MUSC Health Florence leadership and SCTR leadership and research professionals to establish a research infrastructure program to support the conduct of clinical research at MUSC Health Florence.
2. Convene and coordinate a governance committee comprised of relevant leadership and research professionals to review and approve research studies proposed to be conducted at MUSC Health Florence based on institutional and investigator interest in the disease specific area, and the feasibility assessment including adequate patients, budget and resources to conduct the research.
3. Partner with MUSC South Carolina Clinical & Translational Research Institute (SCTR) and participate in regular meetings for training, guidance and support for program and research staff development.
4. Develop and manage research staffing model to support research studies at MUSC Health Florence. Develop position descriptions, post, interview and hire additional staffing as needed to support research studies. Provide research staff supervision and oversight and appropriate training to ensure regulatory compliance and good clinical practice guidelines. Allocates personnel resources to support research portfolio.
Develop and manage financial model to support the costs of conducting research at MUSC Health Florence in collaboration with SCTR and MUSC Health financial officers. Develop tracking and invoicing processes to ensure
5. Developpolicies, processes, and standard operating procedures; implement systems; and develop training manuals to support the conduct of multiple research studies.
Research Operations Research Visits: 50%
1. Serve as a lead research coordinator to support the conduct of research at MUSC Health Florence including study start up, conduct and closeout of studies including
a. Analyze, map and manage study logistics to conduct studies in alignment with IRB approved protocol and informed consent and human subject and other research regulations,
b. document consent for participants in a variety of studies,
c. coordinate and conduct research study visits
d. develop IRB submissions and manage regulatory documents,
e. completes IRB and/or Sponsor reportable events and apply protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.
f. subject screening
g. maintaining subject level documentation
h. create study level SOPs and implement operational plans,
i. perform clinical assessments or interventions and train others on study assessments as appropriate,
j. create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others on these tasks,
k. review study participant charges and implement corrective action plans as needed,
l. ensure that the use of research funding is in compliance with funding agency protocols,
m. obtain, synthesize and interpret recruitment reports to assess effectiveness of recruitment strategies and implement innovative solutions to maximize recruitment strategies by allocating resources appropriately,
n. perform data entry for source and CRF’s to ensure highest quality data collection and capture,
o. perform data coordination including creating data collection forms (CRFs and/or source documents) according to protocol, identify impacts to study budget and cost recovery.
Ethics and Participant Safety-5%
1. Coordinate data for reporting of reportable adverse events to IRB and external monitoring boards and facilitate and submit the completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest.
2. Implement Human Subject Protections and include safeguards to ensure ethical conduct and protection of vulnerable populations for research conducted at MUSC Health Florence.
1. Prepare, participate, and/or lead team meetings. Takes an active role in both programmatic and study decision-making. Responsible for trouble-shooting issues and communicating with other team members and SCTR Leadership accordingly.
2. Proactively identify potential problems and risks to the research participant, study, investigator, research team, and institution and implements conflict management plans per regulations and institutional policies.