UNIV - Research Program Coordinator I - Journey - Department of PHS

Medical University of South Carolina•Charleston, SC

5d•$45,300 - $77,000•Onsite

About The Position

Under the direct supervision of the Vice Chair for Research, Program Director and Program Coordinator II (PCII), the Program Coordinator I (PCI) will assist research investigators in the initiation, coordination, and management of clinical research trials and thus has a significant contribution to ensure assurance of sustainability, efficiency, and compliance. Assists with facilitating and coordinating the daily clinical trial activities and plays an active role in conducting the research studies. Exercises judgment regarding proper patient management, and provides support for the research investigators, faculty, fellows, PCII, and grants administrators.

Requirements

A bachelor's degree and two years of relevant program experience.
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 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)

Nice To Haves

Working knowledge of the following software: SPARQ, eIRB system, and Excel.
Excellent communication, problem-solving and organizational skills.
Previous experience with clinical trial coordination.

Responsibilities

Develops recruitment strategies, plans, and tools. Engages the community, physicians, and identifies barriers to recruitment.
Screens participants independently and provides oversight and training to study team members who screen participants.
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.
Conducts and/or documents consent for participants in a variety of studies independently. Applies knowledge of human subjects' protection regulations in the informed consent process.
Creates a broad array of regulatory submissions (initial study applications) for minimal risk studies. Creates and submits simple regulatory reports (personnel amendments and continuing review applications) to the IRB.
Ensures studies are carried out according to Code of Federal Regulations, Good Clinical Practices, and MUSC policies. Maintains accurate study registration (Clinicaltrials.gov, etc.).
Provides direction to study teams with preparation for study monitoring and study audit visits. Implements corrective action plans, including re-training of staff as needed. Serves as an expert resource when addressing and correcting findings.
Collects, prepares or processes adverse events under supervision.
Provides input on safety reports and submits reportable events to the IRB and/or Sponsor under minimal supervision.
Reviews study participant charges in the medical record and ensures the route according to the Study Billing Plan.
Uses EDC systems to enter data independently and train others on these tasks. Detects issues related to data, capture, collection or management and suggests solutions.
Creates and develops simple to complex databases using research methodology knowledge.
Creates and implements data quality control procedures (data management plan, CRF Completion guidelines, risk-based data monitoring, etc.). Identifies trends, outliers, and discrepancies in the data and implements corrective action plans. Provides training to other research staff on data coordination and management.
Performs literature reviews independently.
Participates in the grant development or research proposal process under direct supervision of the PI.
Assists with identifying the various stakeholders to ensure adequate design, implementation, and testing of study aims.
Summarizes study results.
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.
Creates and/or implements any or all aspects of the dissemination plan. Co-authors research abstracts.
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.
Employs safeguards for human subject protection and/or ensures vulnerable population regulations are adhered to.
Under supervision, adheres to management plans related to conflict of interest.
Makes recommendations to investigators and oversight organizations regarding site resources, recruitment, and budget feasibility for a clinical trial.
Serves as an internal Quality Assurance Monitor and develops and implements protocol specific quality assurance plans. Conducts site-initiation, interim and close-out monitoring visits, writes monitoring reports, and develops corrective action plans related to visit findings.
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.
Maintains study compliance with institutional requirements and other policies and maintains the Delegation of Authority Logs.
Takes part in a committee, taskforce, or ad hoc group within a department. May participate in presentations and/or publications.
Trains staff on various work responsibilities and assigns responsibilities to junior staff. Provides constructive feedback to team members.
Identifies, discusses, and recommends strategies to enhance diversity in clinical trials.
Perform other assigned duties as required.