Research Coordinator II FT, Days

Essential Functions

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

• Manages study operationsby coordinatingday todaystudyoperationsand developing strategies to contribute tothe programgrowth.

• Monitorsstudy progress andmaintainscompliance with protocols and regulations

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

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

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

• 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 - Bachelors 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

• 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: State certification/license in field.

• Some team members may be required to have a valid drivers license to perform the essential functions of the 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 applyGood Clinical Practice (GCP)principlesindependently across studies

• Knowledgeof clinical research regulationsto daily operations

• Ability toapplyprotocol requirementsandtroubleshoot visit issues

• Ability to effectively use specialtyspecific terminology

• Ability toindependently interpret medical records with minimalassistance

• Ability to independently manage quality dataabstractionandensure high-quality sourcedocumentation standards

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