Clinical Research Coordinator
3 weeks ago
ECU Health
About ECU Health
ECU Health is a mission-driven, 1,708-bed academic health care system serving more than 1.4 million people in 29 eastern North Carolina counties. The not-for-profit system is comprised of 13,000 team members, nine hospitals and a physician group that encompasses over 1,100 academic and community providers practicing in over 180 primary and specialty clinics located in more than 130 locations.
The flagship ECU Health Medical Center, a Level I Trauma Center, and ECU Health Maynard Children's Hospital serve as the primary teaching hospitals for the Brody School of Medicine at East Carolina University. ECU Health and the Brody School of Medicine share a combined academic mission to improve the health and well-being of eastern North Carolina through patient care, education and research.
Position Summary
The research specialist may function in finance, regulatory, compliance and/or IT-related research roles.
Responsibilities
Attend and actively participate in assigned meetings
Develops and maintains a timeline for projects and facilitates project completion
Assists with development and implementation of policies and procedures to ensure that the conduct and review of clinical research is in compliance with federal regulations
Stays abreast of federal regulations
Provides guidance to faculty, fellows, residents, and other staff on the preparation, conduct and compliance
documentation necessary for institutional, individual and research subject protections in clinical research
Meets with individual PIs at least monthly to review research activities and needs
Liaison with department experts and leadership on research activities
Conduct preliminary reviews of all new protocols and evaluate expedited, exempt, and full committee submission requests
Oversee the screening of protocol amendments, renewals, closures and deviations as they are submitted for IRB review
Conduct literature and regulatory reviews and prepare reports for the IRB on scientific, ethical, existing and proposed regulatory topics
Oversee and manage the electronic protocol submission system ensuring appropriate documentation is submitted and maintained
Handles or assists with administrative activities generally associated with the financial management of clinical trials.
Processes the Clinical Trials Participant Lists daily, assuring Sponsor related charges are properly recorded for billing.
Sets up New Clinical Trials accounts and work as liaison to clinical trials management, finance and accounting.
Identifies appropriate research rates for procedures outlined in protocol.
Analyzes study coverage analysis to assist in developing study budgets.
Invoices sponsors for study related costs as defined in the Study budget; Processes stipends for payment to Study Participants.
Processes incoming checks for all study accounts.
Reconciles funds and identifies and resolves discrepancies while retaining documentation.
Manages the research portfolios.
Draft guidance documents and policies
Conduct surveillance and internal audits
Provide education and training on research compliance
Perform complex data extraction
Build research databases
Support computer networks
Serve as an educational resource on technology
Perform other related duties incidental to the work described herein.
Minimum Requirements
Bachelor of Science required, preferably in medically-related field.
Master's Degree is preferred
Minimum of 1 year of experience in finance, regulatory, compliance, research, IT, or related field
Experience in a hospital or health-related setting
Strong communication skills
Able to demonstrate strong critical thinking, problem solving, and organizational skills
Ability to work in a team environment
Proficiency with Microsoft Office tools
Technical writing skills
Working knowledge of medical terminology
Other Information
- Location: On site
- Monday - Friday, 8:00 am - 5:00 pm
- Potential for on-call rotation
General Statement
It is the goal of ECU Health and its entities to employ the most qualified individual who best matches the requirements for the vacant position.
Offers of employment are subject to successful completion of all pre-employment screenings, which may include an occupational health screening, criminal record check, education, reference, and licensure verification.
We value diversity and are proud to be an equal opportunity employer. Decisions of employment are made based on business needs, job requirements and applicant's qualifications without regard to race, color, religion, gender, national origin, disability status, protected veteran status, genetic information and testing, family and medical leave, sexual orientation, gender identity or expression or any other status protected by law. We prohibit retaliation against individuals who bring forth any complaint, orally or in writing, to the employer, or against any individuals who assist or participate in the investigation of any complaint.
Contact Information
For additional information, please contact:
Angie Nichols, Talent Acquisition Consultant
ECU Health Talent Acquisition
Email: [email protected]
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