Research Coordinator II, Surgical Research

Inspire health. Serve with compassion. Be the difference.

Responsible for the implementation, management and oversight of clinical trial research studies including the education of research staff, healthcare team member, participants and their caregivers. Registers, compiles, submits and oversees clinical data, monitors study compliance and maintains a system for effective data flow for patients on clinical trials. Manages patient visits and implements protocol related procedures. Responsible for monitoring and communicating study participant progress and safety issues with the investigators, applicable regulatory agencies, health care team and study staff.

• All team members are expected to be knowledgeable and compliant with Prisma Health’s purpose:
  Inspire health. Serve with compassion. Be the difference.

• Manages study operations by coordinating day todaystudyoperationsand developing strategies to contribute tothe program growth.

• Monitors study progress andmaintainscompliance with protocols and regulations

• Supportsinvestigator-initiated studies byassistingwith protocol development, literature reviews, and creation of data collection tools. Coordinatesindustry sponsored clinical trials by implementingsponsor providedprotocols, completing required regulatory submissions, and ensuring adherence to study procedures and timelines.

• Assistsincoordinatingresources to conduct trials including the development of data collection toolsandcommunication with ancillary departments to implement study related procedures.

• Collaborates with Research Services officesandsponsoringor local agencies tosubmitrequiredstudy documents and ensure awareness of study progress, amendments, and regulatory activities.

• Performs other duties as assigned.

• This is a non-management job that will report to a supervisor, manager, director or executive.

• Education
  - Bachelor’s Degree in Health Sciences or Business-related field of study.

• Experience
  - Two (2) years of research experience in at least one of the following areas: pharmaceutical, academic, device, National Institute of Health(NIH), investigator-initiated studies or registry trials.

• In lieu of education and experience noted above an equivalent combination of work experience and academic experience may be considered.

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• BLS is required within six (6) months of employment.

• Collaborative Institutional Training Initiative (CITI) preferred.

• If Allied Health Degree:
  State certification/license in field.

• Some team members may be required to have a valid driver’s license to perform the essential functions of the role. In these situations, an acceptable motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and proof of auto insurance is required.

Knowledge,

Skills and Abilities

• Ability to apply
  
  Good Clinical Practice (GCP) principlesindependently across studies

• Knowledge of clinical research regulations to daily operations

• Ability toapplyprotocol requirementsandtroubleshoot visit issues

• Ability to effectively use specialty‑specific terminology

• Ability to independently interpret medical records with minimal assistance

• Ability to independently manage quality dataabstractionandensure high-quality source documentation standards

• Ability tomaintainongoing professional development byparticipatingin seminars, workshops, in-servicetrainings, and by staying current with relevant literature and emerging trends in the field.

Day (United States of America)

Verdae Practices

Upstate Administrative Research Staff

Upstate Administrative Research Staff-Practice Operations

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