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Prisma Health · 1 month ago

Research Coordinator II, Orthopedics Research, Full Time, Days

Columbia, SC

Full-time

Onsite

Entry, Mid Level

2+ years exp

Prisma Health is dedicated to inspiring health and serving with compassion. The Research Coordinator II will oversee clinical trial studies, ensuring compliance and effective data management while educating staff and participants about the trials.

Health CareHospitalMedical

Responsibilities

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

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

Qualification

Clinical trial managementResearch experienceGCPBLS certificationProficient computer skillsElectronic Medical Record (EMR)Electronic Data Capture (EDC)Patient educationCommunication skillsTeam collaboration

Required

Associates degree in Allied Health OR Bachelor's Degree in health sciences or business-related field of study

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

BLS is required within six (6) months of employment

If Allied Health Degree: State 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

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