UNIV - Program Coordinator I - Journey - Pediatrics: PRG

Job Description Summary

The Research Study Coordinator will be responsible for providing technical and professional support within the Pediatric Research Group (PRG) on interventional and observational 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

53,142.00 - 71,706.00 - 90,372.000

Scheduled Weekly Hours

40

Work Shift

Day (United States of America)

Job Description

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 Research Study 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

This is an on-site position located at MUSC's main campus in downtown Charleston. Remote work may be considered following a one-year probationary period.

This role may require occasional weekend or after-hours work and travel to other MUSC ambulatory clinics within the Charleston area.

Research Operations (35%): Develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment.  Screens participants for all studies independently (i.e screening for eligibility criteria).  Maintains subject level documentation for all studies independently. Train others on Good Clinical Practice guidelines related to study documentation. Independently conducts study visits and may perform complex research assessments. Extracts complex data from electronic medical records. May train others to conduct study visits and perform protocol specific testing/interviews.  Collects, prepares, processes, ships, and maintains inventory of research specimens and provides guidance on system improvements related to specimen handling. Conducts and/or documents consent for participants in minimal risk studies. May conduct consent for studies greater than minimal risk under direct supervision.  Assists with management and tracking of IP at the protocol and subject level. Employs the required system for handling, dispensing, and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling & documenting IP for investigator-initiated protocols and coordination with investigational pharmacies as necessary.  Ensures studies are carried out according to Code of Federal Regulations, Good Clinical Practices, and MUSC policies. Maintains accurate study registration (Clinicaltrials.gov, etc.). Independently creates initial regulatory submissions and annual reports to Federal regulatory authorities and funding agencies (NIH, FDA, etc.) for greater than minimal risk studies. Acts as a site liaison for external IRB submissions and reporting. Corrects audit/monitor findings independently.  Collects, prepares or processes adverse events under supervision.  Completes IRB and/or Sponsor reportable events independently. Applies protocol and institutional guidelines to differentiate between reportable vs. non-reportable adverse events.  Reviews study participant charges in the medical record and ensures the route according to the Study Billing Plan.

Data Informatics (30%): Completes case report forms and enters data into EDC system(s). Resolves data queries.  Assists with the creation of simple data collection forms (surveys, CRFs, and/or source documents).

Communication (15%): Prepares for and participates in team meetings. Serves as a primary liaison between Sponsor, PI, vendors, sub-contracts, and ancillary services including Investigational Drug Services Pharmacy, Lab, Imaging, NEXUS, and Hospital services, etc.

Ethics and Participant Safety (5%): Under direction provides data for external monitoring reports and/or facilitates completion of documents related to Research Data Security Plans, Data Safety and Monitoring Plans, and Conflict of Interest. Understands the ethical conduct of research and safeguards needed when conducting human subjects research activities.

Site and Study Management (10%): Collects information related to recruitment numbers and resources for study teams to help determine site trial feasibility. 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.

Other (5%): Other duties as assigned

Additional Job Description

Minimum Requirements: A bachelor's degree and two years 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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