UNIV - Program Coordinator I - Pediatrics: PRG

Job Description Summary

The Program Coordinator will be responsible for providing technical and professional support within the Pediatric Research Group (PRG) on interventional and observational clinical trials. The position will coordinate with the Program Manager, Principal Investigator(s) (PI), and other research personnel involved in human research as delegated. The Research study coordinator will be responsible for serving as the primary coordinator on studies as well as providing back-up or additional support for other PRG coordinators and will involve direct patient contact.

Entity

Medical University of South Carolina (MUSC - Univ)

Worker Type

Employee

Worker Sub-Type​

Research Grant

Cost Center

CC001013 COM PEDS Children's Research Institute CC

Pay Rate Type

Hourly

Pay Grade

University-05

Pay Range

38,985.00 - 55,559.50 - 72,134.000

Scheduled Weekly Hours

40

Work Shift

Job Description

The Program Coordinator will be responsible for providing technical and professional support within the Pediatric Research Group (PRG) on interventional and observational clinical trials.  The position will coordinate with the Program Manager, Principal Investigator(s) (PI), and other research personnel involved in human research as delegated.  The Research study coordinator will be responsible for serving as the primary coordinator on studies as well as providing back-up or additional support for other PRG coordinators and will involve direct patient contact.

The Program Coordinator duties include:

• Scheduling and conducting study visits and assessments per protocol
• Collecting, processing, shipping, and maintaining inventory of research biological specimens
• Ensuring timely and accurate data collection following GCP and ALCOA++ guidelines
• Maintaining accurate and up-to-date paper and electronic regulatory files
• Performing pre-screening activities through screening, medical chart review, and in person discussions with study investigators to aide with recruitment
• Preparing and creating essential study documents including worksheets, source documents, and study logs
• Assisting with and completing IRB submissions, including initial submissions, amendments, reportable events, and continuing reviews
• Serving as the primary liaison between site staff, sponsors, study vendors and other internal departments involved in the conduct of clinical research

Job Duties:

• 10% - Assists with management and tracking of Investigation Product (IP) during study visits at the protocol and subject level.
  Employs the required system for handling and documentation of IP for sponsored protocols within systems such as IWRS / IVRS.
  Collects, prepares, processes, ships, and maintains inventory of research specimens and provides guidance on system improvements
  related to specimen handling. Corrects audit/monitor findings. Work with PIs on reporting adverse events to the IRB. Reviews study
  participant charges, identifies discrepancies and escalates to appropriate offices to ensure appropriate research billing compliance.
  (Essential)

• 10% - Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, program managers, vendors,
  sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, Lab, Imaging, and Hospital services, etc., in
  the coordination of services needed. - (Essential)

• 15% - Makes recommendations to investigators and oversight organizations regarding site resources, and recruitment, for a clinical
  trial. Determines and allocates resources at a study level. Develops study protocol-specific systems and documents including process
  flows, training manuals, standard operating procedures, and case report forms. Ensures study teams are compliant with institutional
  requirements/policies: provides training to staff around these policies and ensures appropriate study specific training plans per
  Delegation of Authority Logs. Responsible for maintaining protocol specific training of all staff members listed on Delegation of
  Authority logs. - (Essential)

• 20% - Independently creates regulatory submissions and annual reports to regulatory authorities and funding agencies (NIH, FDA,
  etc.) and completes required supplemental regulatory documents (IND/IDE, Certificate of Confidentiality, etc.) for all studies.
  Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events. - (Essential)

• 35% - Screens participants for all studies independently (i.e screening for eligibility criteria). Maintains subject level documentation
  for all studies independently. Conducts and assist with study visits and may perform research assessments. Extracts data from EPIC.
  Conducts and/or documents consent for participants in a variety of studies independently applying knowledge of human subject’s
  protection regulations in the informed consent process. - (Essential)

• 5% - Other duties as assigned. - (Essential)

• 5% - Uses EDC systems to enter data, in a timely manner. Detects issues related to data capture, collection or management and
  suggests solutions. Responsible for response to study specific queries within the EDC system in a timely manner. Creates data
  collection forms (CRFs and/or source documents) according to protocol. - (Essential)

This position will be required to work on campus but may be eligible to work a hybrid work from home model after a probationary period. Position may also require weekend or after-hours work.

Additional Job Description

Minimum Requirements: A bachelor's degree and one year 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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