Trauma Research Coordinator - Oklahoma Children's

OU Health•Oklahoma City, OK

33d

About The Position

As Oklahoma’s only Level I Adult and Pediatric Trauma Center, OU Health leads the state in trauma education, prevention, and outreach. The program equips healthcare professionals and community members with life-saving knowledge and skills through a wide range of initiatives. The Trauma Research Coordinator is responsible for research data design, collection, and evaluation on trauma patients at OU Health and assists in generating trauma-related clinical and bench research projects. The position collaborates will several teams including Medical Directors, Trauma Residents, Faculty and Providers to develop research and coordinate all aspects of the projects with the goal of abstract submission and presentation with eventual manuscript publication. This position has responsibility for ensuring trauma research criteria is met to satisfy verification status as a Level One Trauma Center for the American College of Surgeons (ACS).

Requirements

Bachelor's Degree is required.
At least 3 years of experience coordinating clinical studies is required.
Certified Clinical Research Professional (CCRP) issued by the Society of Clinical Research Associates (SOCRA) or ACRP Certified Professional (ACRP-CP®) from The Association of Clinical Research Professional (ACRP) required within 1 year of hire.
Knowledge of patient evaluation and triage procedures.
Ability to monitor clinical research patients from many disciplines.
Strong ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Strong data management skills and attention to detail.
Ability to participate in protocol review and clinical trials evaluations.
Strong knowledge of medical terminology.
Ability to handle competing demands with diplomacy and enthusiasm.
Extensive knowledge of Microsoft Word, Excel, Adobe Acrobat, and REDCap.
Familiarity with Good Clinical Practices (GCP).
Ability to read and understand clinical trials protocols.
Understanding of the IRB submission and review process and when and how to apply for IRB review.
Understanding of the federal research regulations and the ability to identify the federal research organizations’ role in regulating human research participation.
Due to the nature of trauma related research, must be able to occasionally work evening, night and weekends to accommodate patient enrollment, data collection or other study needs.

Responsibilities

Manages multiple moderately complex studies that may include national level and multi-institutional collaboration.
Responsibilities include recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
Conducts all sponsor-related visits and acts as a liaison between sponsor and Principal Investigator (PI).
Reviews and meets regularly with PIs and the Trauma Medical Director to review study portfolio.
Participates in study start-up activities.
Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor, and IRB under general direction of clinical research manager.
Organizes and actively participates in site visits from sponsors and other relevant study meetings.
Maintains a safe research environment and ensures compliance with governmental and University policies, procedures, and regulations.
Facilitates and participates in the daily activities of moderately complex studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Coordinates the collection of analyzable clinical research data and/or samples.
Contributes to problem solving on assigned clinical research studies and tasks.
Submission of research protocols to the IRB for approval.
Attend monthly A+PRN research meetings.
Attend the A+ bi-annual meetings, national peds trauma meetings, and the Western Pediatric Trauma Conference (WPTC), and the Pediatric Trauma Society (PTS).
Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol.
Provides efficient and complete data collection, processing, analysis and reporting.
Assures source documentation, data abstraction and entry are being done at the protocol specified time-points.
Ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries.
Facilitates the exchange of data across projects and organizations.
Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
Collaborates with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.
Ensures compliance with federal regulations and institutional policies.
Advises staff on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other compliance related aspects of the clinical study.