Clinical Research Coordinator (Part -Time)

The Geneva Foundation•Saint Mere Eglise, NC

1d•Onsite

About The Position

The Clinical Research Coordinator provides assistance to the Principal Investigator and Study Team coordinating research activities that may include assistance with clinical patient outcomes collection, recruiting research participants, data collection and management, on-site regulatory assistance, and other research activities as assigned. The Clinical Research Coordinator will assist with report generation and project close-out support. The position will support the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) Program. This program was established to support the execution of clinically relevant research to advance the care of service members with non-combat related musculoskeletal injury (MSI). Headquartered at the Uniformed Services University of the Health Sciences (USU), MIRROR provides coordination and support of inter-service and inter-disciplinary partnerships across military treatment facilities (MTFs), military training centers (MTCs), and civilian academic centers to execute cutting-edge research in order to mitigate the burden of MSI on military readiness. This role will specifically contribute to a research initiative titled "SGB+K: 54 - Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ketamine, Stellate Ganglion Blocks and Combination Treatment to Sham Therapies for Traumatic Brain Injury-Associated Headaches and Post-Traumatic Stress Disorder." The purpose of this study is to evaluate the efficacy and comparative effectiveness of stellate ganglion block (SGB) and ketamine infusion for treating PTSD and post-traumatic headache in a military population. Through a randomized, double-blind, placebo-controlled trial, the study aims to determine the impact of these interventions on patient-reported outcomes and quality of life.

Requirements

Bachelor's degree from an accredited university or equivalent work experience required
2-4 years experience in clinical research preferred
2-4 years non-profit, research, or healthcare experience desired
Demonstrate competence in oral and written communication
Must be organized, attentive to detail, and posses a positive, friendly and professional demeanor
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software
Knowledge of CFR, GCP and ICH guidelines
Must possess current BLS (Basic Life Support) certification and maintain it during the term of the contract

Responsibilities

Promote safety and confidentiality of research participants at all time
Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP), and infection control procedures
Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedure
Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data
Demonstrate proficiency in performing study related clinical procedures and interventions
Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope
Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives
Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives
Document all correspondence and communication pertinent to the research
Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization
Comply with all the rules and regulations as applicable to assigned duty station
Create and adhere to a data quality and quality assurance plan
Assist with interim and annual reports.
Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.)

Benefits

medical, dental, and vision healthcare
Flexible Spending Account
Health Savings account, with employer contribution
Coverage is provided for employees and family members including domestic partners
Short-and long-term disability
Employee Assistance Program
Life & ADD insurance
403b retirement plan with generous employer match
flexible leave options
11 paid holidays per year
up to 4 weeks of paid time off in a rolling year
Employees may qualify for PSLF as Geneva is a 501(c)(3) nonprofit organization.