Research Project Manager - MUSC (Med. Univ of South Carolina) : Job Details

Job Description Summary

This position will serve as the Research Project Manager to develop and support a clinical research program at MUSC Health Orangeburg. This position will be responsible for leading the development of a sustainable operational and financial research model to conduct clinical research studies at MUSC-Orangeburg in collaboration with MUSC Health Orangeburg 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 Orangeburg and will hire and supervise additional research coordinators and other staff as required to support research at MUSC Health Orangeburg.

Entity

Medical University Hospital Authority (MUHA)

Worker Type

Employee

Worker Sub-Type

Regular

Cost Center

CC004870 ORBG - Clinical Research

Pay Rate Type

Salary

Pay Grade

Health-28

Scheduled Weekly Hours

40

Work Shift

Job Description

Minimum Requirements:

Bachelor's degree is required, preferably in health-related science. Previous experience in healthcare setting is required. Previous research experience is preferred including, research coordination, budget development, and regulatory management.

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 Orangeburg [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.

Job Duties:

Program Development and Oversight - 40%

Engage in strategic planning and program development with MUSC Health Orangeburg leadership and SCTR leadership and research professionals to establish a research infrastructure program to support the conduct of clinical research at MUSC Health Orangeburg. 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 Orangeburg 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. 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. Develop and manage research staffing model to support research studies at MUSC Health Orangeburg. 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 Orangeburg in collaboration with SCTR and MUSC Health financial officers. Develop tracking and invoicing processes to ensure

Develop policies, processes, and standard operating procedures; implement systems; and develop training manuals to support the conduct of multiple research studies.

Research Operations Research Visits: 50%

Serve as a lead research coordinator to support the conduct of research at MUSC Health Orangeburg including study start up, conduct and closeout of studies including

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,

document consent for participants in a variety of studies,

coordinate and conduct research study visits

develop IRB submissions and manage regulatory documents,

completes IRB and/or Sponsor reportable events and apply protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.

subject screening

maintaining subject level documentation

create study level SOPs and implement operational plans,

perform clinical assessments or interventions and train others on study assessments as appropriate,

create, optimize, and oversee systems to collect, prepare, process, ship, and maintain inventory of research specimens and train others on these tasks,

review study participant charges and implement corrective action plans as needed,

ensure that the use of research funding is in compliance with funding agency protocols,

obtain, synthesize and interpret recruitment reports to assess effectiveness of recruitment strategies and implement innovative solutions to maximize recruitment strategies by allocating resources appropriately,

perform data entry for source and CRF's to ensure highest quality data collection and capture,

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%

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. Implement Human Subject Protections and include safeguards to ensure ethical conduct and protection of vulnerable populations for research conducted at MUSC Health Orangeburg.

Communication-5%

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. 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.

Additional Job Description

Education: Bachelors Degree or equivalent Work Experience: 5 years for support or 0-2 years for professional

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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