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MC3 CLINICAL PROGRAM MANAGER
Job Title: MC3 CLINICAL PROGRAM MANAGER
Job Code: 1656
FLSA: E
Job Level: 71
Revised Date: 05/01/2018
Job Family: JF 28
Occupational Summary
Oversee and direct the process for the Foundation for the Accreditation of Cellular Therapy (FACT) reaccreditation of the Pediatric Blood and Marrow Transplant Program (PBMT). Review all investigations on deviations from the Carolinas Cord Blood Bank (CCBB), the Robertson GMP Facility and the Stem Cell Lab (SCL), prior to Medical Director sign off. Critically and analytically check investigations for completeness, thoroughness and compliance with FDA and GMP regulations. Follow-up with patients as delegated by Medical Director. Communicate with them regarding treatment options and available clinical trials. Add documentation notes to EPIC. Lead and oversee special projects as delegated by Medical Director.
Work Performed
Oversee and direct the process for the Foundation for the Accreditation of Cellular Therapy (FACT) accreditation of the Pediatric Blood and Marrow Transplant Program (PBMT).
Maintain SOPs in Master Control for PBMT clinical procedures for recipient care, donor evaluation and management, patient follow-up and outcome evaluation.
Manage the reaccreditation submission.
Perform gap analysis against standards and identify areas to fill. Develop and update standard operating procedures (SOPs) as needed to address those gaps.
Educate staff in the PBMT inpatient hospital and the day clinic regarding both new and updated policies and procedures, FACT standards, manuals, SOPs, and quality plans.
Conduct audits to ensure compliance with deferral, state, FACT, FDA, NIH, HRSA and all other governmental regulations.
Maintain training files for clinical staff as required by FACT.
Prepare staff for the accreditation inspection.
Host inspectors and act as Subject Matter Expert (SME) during the FACT inspection.
Review observations and lead the response team to the observations.
Review and complete as needed all issue reviews and investigations on deviations from the Carolinas Cord Blood Bank (CCBB), the Robertson GMP Facility and the Stem Cell Lab (SCL), prior to Medical Director sign off.
Critically and analytically check investigations for completeness, thoroughness and compliance with FDA and GMP regulations, and edit or request changes from author as needed.
Review all investigations triggered by internal or external complaints.
The external complaints may be motivated by product complaints (cracked bag, positive sterility, etc.) or by patient related issues (Adverse Events (AE) and Serious Adverse Events (SAEs).
Be primary point of contact and author for all investigations related to AEs and SAEs.
Follow up with patients as delegated by Medical Director.
Communicate with them regarding treatment options and available clinical trials.
Add documentation notes to EPIC for patient communications via phone and email.
Summarize patient correspondence and relevant clinical events.
Update problem lists and other documentation (dx, meds) in EPIC for legacy patients that were not included in the EPIC conversion.
Lead and oversee special projects as delegated by Medical Director.
Examples of projects include but are not limited to, developing SOPs for aspects of new clinical research programs, developing background sections for new clinical trials protocols or new manuscripts; determining labelling requirements for new GMP products, etc.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Education/Training
Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist or related healthcare field.
Experience
Six years of clinical healthcare or clinical research experience.
Skills
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
