Job Description Summary
This position is for a Program Coordinator II that is under the direction of the Program Manger assuming responsibility and accountability in providing management of study related procedures for patients enrolled in phase I-IV Gene Therapy clinical trials.
Entity
Medical University of South Carolina (MUSC - Univ)
Worker Type
Employee
Worker Sub-Type
Research Grant
Cost Center
CC001014 COM PEDS Clinical Research CC
Pay Rate Type
Salary
Pay Grade
University-GEN09
Pay Range
52,100.00 - 70,300.00 - 88,600.000
Scheduled Weekly Hours
40
Work Shift
Job Description
This position is responsible for coordinating and managing clinical trials, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Key Duties include:
- Completing required submissions to the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC).
- Working alongside the program manager and other internal departments to review budgets and contracts.
- Completing case report forms (CRFs) and answering queries in a timely manner
- Providing education to subjects in line with protocol requirements.
- Collecting and reporting adverse events information as required per protocol
- Maintaining screening, study visits, training and consent logs in the Investigator site files.
- Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit.
- Serve as the liaison to external stakeholders.
- Providing mentorship to junior staff members with areas of training and development.
- Facilitating necessary procedures required for gene therapy including but not limited to cryo-preservation, apheresis, radiology, and fertility banking.
- Serve as expert resource for hospital staff performing study related procedures.
- Coordinating home health services, transportation, and discharge care for study participants on a protocol specific basis.
- Working with transplant team to coordinate inpatient hospital stays per study requirements including scheduling line placements, bone marrow aspirate/biopsies, and getting appropriate medical clearances.
Research Operations Research Visits: 35%
1. Recruitment: Synthesizes and interprets recruitment reports to assess effectiveness of recruitment strategies and implements innovative solutions to maximize recruitment strategies by allocating resources appropriately.
2. Screening: Provides oversight and training to entire team unit with regards to subject screening. Establishes systems and policies related to subject screening.
3. Study visit preparation and documentation: Provides oversight and training to study team members, including clinic staff, regarding preparation of study visits, maintenance of subject level documentation and creation of study level SOPs.
4. Conduct study visits: Serves as a team resource and trains others regarding the conduct of study visits, creation of study level SOPs and implementation of operational plans. May perform advanced clinical assessments or interventions and trains others on study assessments.
5. Specimen collections: Creates, optimizes, and oversees systems to collect, prepare, ship, and maintain inventory of research specimens and trains others on these tasks.
6. Informed consent: Provides oversight (to include review) to study team members who conduct and document consent for participants in a variety of studies. Serves as an expert resource and trainer across department or unit on the consent process and related documentation.
7. Investigational Products: Responsible for the management of IP. Oversees and serves as an expert resource for study teams on the implementation of and compliance with required systems for IP handling, dispensing and documentation.
8. Regulatory management: Responsible for creating and/or implementing policies and procedures related to department/unit-wide regulatory management.
9. Interactions with IRB: Serves as a department/unit-wide resource for the development of IRB submissions and for guidance on IRB communications.
10. Preparation for study monitoring/audit visits: Responsible for creating and/or implementing department/unit-wide policies and guidance related to monitoring and audits.
11. Adverse event collection and safety reporting: Oversees adverse event collection or provides expert guidance on identifying adverse events.
12. Safety Reporting: Oversees the IRB safety report documentation for the entire department or unit. Serves as a resource to department, unit, or division on safety reporting.
13. Billing Compliance: Serves as a resource and trains other staff on reviewing study participant charges and implementing corrective action plans. Ensures that the use of research funding is in compliance with funding agency protocols.
Data and Informatics-10%
1. Data Entry: Serves as a departmental/ unit-wide resource on CRFs, provides oversight to ensure highest quality data collection and capture.
Communication-10%
1. Communication with sponsors, sites, CROs & Teamwork: Prepares for and leads departmental, unit or division-wide meetings. Mentors junior staff to improve ability to participate in team efforts.
2. Gene Therapy Specific Communications: Facilitates gene therapy specific coordination with various departments including but not limited to cryo-preservation, apheresis, radiology, bone marrow transplant team, and fertility banking. Implements home health services, transportation, and discharge care for study participants on a protocol specific basis.
Ethics and Participant Safety-5%
1. Implementation of Human Subjects Protections: Serves as an expect resource to study teams as they design studies, so they specifically include safeguards to ensure ethical conduct and protection of vulnerable populations.
2. Conflict of Interest: Creates policies and guidances at the department/ unit-wide level regarding ethical considerations.
Leadership and Professionalism-10%
1. Leadership Involvement: Leads a departmental committee, task force, or ad hoc group or participates in institutional committees, task force, or ad hoc group as a subject-matter expert. Leads scientific or programmatic presentations and publications.
2. Management and mentorship: Serve as a leader to entire department/unit or leads a mentorship program within the department/unit. Defines programmatic vision and direction.
Site and Study Management-25%
1. Trial Feasibility: Makes recommendations to investigators and oversite organizations regarding site resources for study teams to help determine site trial feasibility.
2. Budgeting and Financial Management: Oversees and is directly responsible for budget development such as translating protocol-specific activities into budget related costs and/or developing external and internal budgets and determining rates of return. May also develop or monitor budget reports, project revenue and expenditures.
3. Quality Assurance: Oversees department or unit-wide quality assurance program and ensures corrective action plans are implemented appropriately.
4. Managing Resources: Oversees department/unit-wide processes related to research resources and finances.
5. Operational Plans: Creates unit-wide, and may collaborate to create institution-wide, policies and guidances regarding research operations and plans.
6. Managing Risk: Responsible for or leads the development and/or implementation of policies and guidelines related to compliance with institutional requirements and other policies. Also ensures appropriate training of all staff related to risk management. May also participate in or lead policy development and/or provide training at the institutional level.
Other duties as assigned – 5%
Additional Job Description
Minimum Requirements: A bachelor's degree and four years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent)
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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