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UNIV - Program Manager I - Department of OB/GYN

Apply now Job no: 519391
Entity: MUSC University
Department: COLLEGE OF MEDICINE - COM-OB/GYN
Sub Department: UNIV-2233100-Ob/Gyn Chair
Work type: Full-Time
Employee Type: UNIV - Research Grant
Location: Charleston, SC-Main Campus
Categories: ADMINISTRATIVE & NON-CLINICAL PROFESSIONALS
Pay scale: UNIV-Band 7: $49,594.00 - $70,674.00 - $91,755.00 (min - mid - max)

Job Duties:
10Responsible for planning, developing and overseeing external and internal research budgets. Works directly with the OBGYN Business Administrator, Finance Manager and SCTR on negotiations with sponsors. Translates protocol- specific activities into budget related costs (i.e. identify and determine CPT codes, FTE, etc.)Essential
25Manages pre-award activities and identifies potential research opportunities. Conducts analysis, completes feasibility questionnaire and determines appropriateness of trial opportunity to include preparatory to research patients for prescreening. Manages the grant development process and works directly with PI’s and ORSP to obtain grant approval.Essential
25Manages the day to day operations of current studies and ensures compliance with GCP Guidelines, Federal Regulations and Institutional policies for the Department of OBGYN. Provides guidance to research coordinators and PI’s with study issues. Directly responsible for the management of study implementation, recruitment, informed consent, data coordination, collection, safety reporting, quality assurance, storage and inventory, reimbursement payments, study closeout, billing and compliance. Participates in external and internal audits with MUSC and FDA compliance agents. Develops SOP’s for the operation of the research department. Acts as a liaison between Sponsor, PI and ancillary services including investigational Drug Services Pharmacy, Lab Imaging, NEXUS and hospital services, etc.Essential
25Supervises research staff, performs yearly evaluations, maintains work schedules and leave request. Responsible for training and educating staff on ICH/GCP guidelines, FDA regulations as well as MUSC research policies and procedures. Recruits, hires and provides adequate training to perform job duties, ensures employees are meeting MUSC standards of behavior and code of conduct. Performs disciplinary actions as required.Essential
5Manages OB/GYN Lab areas and ensures a safe environment for employees and visitors in accordance of Occupational Health Safety. Responsible for staff training and technical support with laboratory equipment. Attend laboratory planning meetings. Ensure good communication with laboratory staff and faculty who use lab spaces.Essential
5Regulatory Affairs includes maintains regulatory and training documents as required by Federal, State, Local, Institutional and protocol regulations and policies. Creates and submits regulatory reports to the IRB. Prepares and submits to sponsor requested regulatory documents, training documents and other required documentation. Identifies, completes and submits required supplemental regulatory docs, act as a regulatory authority and advisor training and educating employees/faculty and advising research team. Acts a primary back up for regulatory coordinator as needed.Essential
5Responsible for all account receivables pertaining to the contract agreement and guidelines for study activity. All other duties as assigned.Essential


Job summary: Under the direction of the Business Administrator in the Department of OB/GYN, the Program Manager assists with the development of operational policies and procedures and ensures all clinical research protocol requirements are being adhered to per policies. Responsible for the clinical management of the program operations and management of the research staff.


Payscale Salary Range: UNIV-Band 7: $49,594.00 - $70,674.00 - $91,755.00 (min - mid - max)


FLSA: Salaried


Minimum Experience and Training Requirements: A bachelor's degree and three years relevant program experience.


Physical Requirements: 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 lift objects, up to 15 lbs., from floor level to height of 36 inches, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/20 vision, corrected. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to match or discriminate between colors. (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 hear and/or understand whispered conversations at a distance of 3 feet. (Frequent) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) Ability to work in dusty areas. (Infrequent)

 

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.


Opening date: Eastern Standard Time
Applications close: Eastern Standard Time

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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.