Research Coordinator II, FT

Inspire health. Serve with compassion. Be the difference.

Job Summary

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.

Essential Functions

• All team members are expected to be knowledgeable and compliant with Prisma Health's purpose: Inspire health. Serve with compassion. Be the difference.
• Assists in determining patient eligibility for enrollment in research studies. Identifies individual patient needs to facilitate participation including identifying and pre-screening potential participants. Registers patients into research studies to meet protocol parameters. Assists MD investigator in the informed consent process.
• Provides coordination over assigned research staff. Ensures assigned study staff practice within the parameters of their qualifications and collaborates with team members for optimal functioning of the unit/department. Trains and oversees personnel managing studies and regulatory matters.
• Collaborates with other health team members to formulate an interdisciplinary plan of care and plans a schedule of patient activities related to the study requirements. Instructs participating health care team members in clinical trials procedures, and orients health care professionals to the clinical studies program Interacts with other members of health team to monitor protocol compliance and to ensure that the assigned patient care needs are met.
• Identifies specific learning needs and abilities of patients/families to provide appropriate education at the level of the recipient. Provides patients/families with information regarding clinical trial participation and provides education regarding individual treatment including purpose, potential side effects, and self-care measures, documents interaction. Maintains patient privacy per institutional and study related policies.
• Gathers and abstracts study data and documents in a factual, concise manner which meets regulatory/unit standards. Achieves, timely, thorough and accurate completion and evaluation of case report forms. Reviews records/forms for compliance with protocol requirements. Prepares for and manages pre-site, study initiation, interim monitoring, and close-out visits. Assists investigator in the completion of data queries. Gathers records, reports, lab results, radiographs, scans, and other materials required for institutional, sponsor and FDA audits.
• Collaborates with Prisma Health Research services, including the CRMO (Clinical Research Management office, IRB (Institutional Review Board) and OSP (Office of Sponsored Programs) and sponsoring agencies as well as local agencies, when applicable, to ensure global awareness regarding the progression of various studies, amendments and regulatory monitoring. Attends Investigator Meetings as appropriate. Prepares and presents lectures and/or written materials for health care provider education and participates in presentations or seminars related to the research study when necessary.
• Manages study related inventory including, data collection tools, study supplies and study medication, if applicable. Schedules visits with the sponsoring agencies.
• Assists department manager/supervisor to coordinate resources to appropriately conduct the trial including the development of data collection tools, communication with ancillary departments to implement study related procedures. Collaborates with study team to develop new strategies for the growth of the Research program. Communicates study related issues with research management.
• Assists investigator in the development of investigator-initiated research studies including the development of protocols, literature searches, and data collection tools as well as assistance in the submission of investigator-initiated studies to the IRB and sponsoring agencies, if applicable.
• Maintains professional growth and development through seminars, workshops, in-service meetings, current literature and professional affiliations to keep abreast of latest trends in field of expertise.
• Performs other duties as assigned.

Supervisory/Management Responsibilities

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

Minimum Requirements

• Education - Associates degree in Allied Health OR 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, NIH, investigator-initiated studies or registry trials.

In Lieu Of

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

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Required Certifications, Registrations, Licenses

• BLS is required within six (6) months of employment.
• Collaborative Institutional Training Initiative (CITI) preferred.
• If Allied Health Degree: Sate certification/license in field.
• Research Coordinator IIs may be required to have a valid driver's license, an acceptable motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and proof of auto insurance.

Knowledge, Skills and Abilities

• Knowledge of office equipment (fax/copier)
• Proficient computer skills (word processing, spreadsheets, database, data entry)
• Knowledge GCP, FDA Rules and Regulations and policies in relation to clinical trials.
• Familiar with Electronic Medical Record (EMR) and Electronic Data Capture (EDC) systems

Work Shift

Day (United States of America)

Location

Greenville Memorial Med Campus

Facility

2507 Upstate Administrative Research Staff

Department

Upstate Administrative Research Staff-Practice Operations

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