Full-Time

UNIV-Research Program Coordinator I: Neurology: Translational Research Unit

Confirmed live in the last 24 hours

Medical University of South Carolina

Medical University of South Carolina

Compensation Overview

$39k - $72.1kAnnually

Entry, Junior

No H1B Sponsorship

Charleston, SC, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
PowerPoint/Keynote/Slides
Requirements
  • A bachelor's degree and three years relevant program experience.
  • Must be able to function independently with minimal supervision and act with discretion and confidentiality.
  • Must be self-directed individual with excellent communication and interpersonal skills.
  • Must be a detail-oriented individual with excellent organizational skills.
  • Must be able to manage multiple tasks successfully and work collaboratively with other professionals.
  • Requires proficiency in use of Microsoft Office (Excel, Word, Powerpoint & Access).
Responsibilities
  • Serves as lead coordinator on assigned projects to include following departmental policies and procedures and Good Clinical Practice guidelines, tracking recruitment, screening and enrollment of research participants, coordinating research visits with other members of the research team as needed to facilitate seamless study visits, managing data collection and data entry, reviewing documentation for accuracy and data validity as needed, and serving as a resource for and interacting with ancillary services (laboratory, radiology, investigational pharmacy) to prevent and or resolve any issues.
  • Coordinates all phases of clinical trials regulatory management for assigned studies: (i.e. study start-up/initial submission, interim maintenance, annual renewals, amendment processing and closeout activities.) Under the direction of the PI, prepares all levels of regulatory documents for study implementation, ongoing maintenance, and amendments to include sponsor required documents, as well as local IRB documentation. Prepares and finalizes required Sponsor and Departmental regulatory/compliance reports.
  • Coordinates roles and activities of research studies in collaboration with the TRU director/PI and finance team to ensure effective and efficient workflow that meets study/organizational goals. Records all financial activities of study for billing sponsors and paying subcontractors and vendors. Acquires, inventories, and stores protocol-specific research supplies. Retrieves and transports study drugs. Performs drug accountability and reconciliation tasks. Establishes research record in EMR system.
  • Serves as a lead on special projects such as performing clinical assessments and rating scales for human subjects as required by study protocol. Perform safety assessments to include vital signs, electrocardiograms, blood draws, and lab processing. Works collaboratively with the TRU Director and other core members of the department to identify gaps in research tools and resources and develop new processes and tools to meet the needs of the research community. Disseminates these tools and resources to MUSC’s research community as appropriate.
  • Participates in new employee orientation and training on the Code of Federal Regulations, and 'Good Clinical Practices' (GCPs) to staff; provides oversight, guidance and mentorship, Research Interns, and other research personnel within the Department of Neurology and across departments on the day-to-day operations of conducting clinical research. Provides expert training to the MUSC research community on MUSC’s research processes and resources.
Medical University of South Carolina

Medical University of South Carolina

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