Clinical Research Coordinator at Odyssey Systems Consulting Group, Ltd.

Portsmouth, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Apr, 26

Salary

0.0

Posted On

12 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, IRB Support, Data Collection, Patient Education, Regulatory Compliance, Medical Terminology, Organizational Skills, Analytical Skills, Microsoft Office, Research Protocols, Communication Skills, Team Collaboration, Inventory Management, Training Development, Specimen Handling, Adverse Event Reporting

Industry

Government Administration

Description

Position Summary Odyssey is seeking a Clinical Research Coordinator to support the Clinical Investigation Department (CID) at the Navy Medical Center, Portsmouth (NMCP) Virginia. The mission of the command is to support the national interests of the United States by providing professional education and development, providing quality patient care, being responsive and ready for deployment, and taking care of each other as shipmates. NMCP conducts biomedical research in general surgery, psychology, otolaryngology, pediatrics, nursing research, orthopedics, women’s health, and emergency medicine, which are relevant to the Graduate Medical Education Program. Responsibilities Duties include, but not limited to: Provide research support for IRB and IACUC approved research protocols. Support the Department Head of the CID, Directorate for Professional Education, NMCP. Support the Department Head of CID and is accountable for research matters to the PIs of each research protocol in accordance with federal and local regulatory guidelines. Use programs such as Word, Excel, etc., as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA). For consultation, reporting, exchange of information, orientation support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors. Provide IRB/HRPP support to the PI in the development and implementation of recruitment strategies in accordance with IRB/HRPP requirements and approvals. Screen recruited research subjects using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design after the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented. Assist the research pharmacist with correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability. Provide subjects with education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable. Assist with maintaining adequate inventory of study supplies, including drugs, and devices, and preparation of other study materials. These study materials include the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs. Assist the PI by providing materials and tools necessary for the development of appropriate training of individuals involved in the execution of a study related to protocol requirements, schedule of visits, execution of research plan, and maintain documentation of training. In collaboration with the PI, check on the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol. Observe universal precautions and OSHA standards when processing or handling specimens. Obtain laboratory results and consult with the PI for follow-up care as per protocol. Collect data in a timely and accurate manner and submit information to coordinating centers. Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations. Review compliance of research subject and complete documentation of status and progress. Respond to Assurance Specialist discrepancy/findings and, after consultation with PI, communicate approved recommendations. Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol. Maintain detailed documentation of the research study including subject study charts and databases as required by the protocol, and the Investigator’s File Binder or Regulatory Binder. Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol. Interact on a regular basis with the PI and study team members regarding the conduct of the research study. Attend conferences and other meetings as required by the protocol. Return telephone calls from research participants within 48 hours and document interactions appropriately. Work is performed in ambulatory care spaces and inpatient wards with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons. Maintain patient confidentiality in accordance with HIPAA and institutional regulations. Actively participate in CID departmental and command-wide research educational and training programs by providing instruction and presentation materials to assist research staff, as needed. Actively participate in assurance assist visits and regulatory audits for protocol compliance. Assist PI, research team members, and other staff in the preparation of and closeout of clinical research studies. Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols. Qualifications Minimum Required Qualifications: Citizenship: Must be a US citizen Clearance: Ability to obtain a Secret Clearance Education: Bachelor’s Degree from an accredited college or university Certifications: Certified Clinical Trial Investigator (CCTI) Certified Clinical Research Coordinator (CCRC) Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). Years’ experience: A minimum of two (2) years as a Clinical Research Coordinator within the past five years OR Current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). Minimum of two (2) to four (4) years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience. Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge. Ability to communicate effectively, both orally and in writing. Possess effective organizational and analytical skills with ability to work independently and in a team environment. Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program. Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date Preferred Qualifications: Clearance: (ability to obtain) Secret Clearance Additional Information: Location: Navy Medical Center, Portsmouth (NMCP) Virginia On-site (local candidates only) #LI-JC1 Company Overview Odyssey Systems is a world-class technical, engineering, and integration company serving the warfighting ecosystem with airborne integration, ISR, C2, and warfighter readiness capabilities. Odyssey meets the military’s operational needs by integrating layered defense systems from equipment, technology, and services to data, information, and business operations. We streamline defense acquisition and sustainment, engineering the technical battlefield with domain-specific proficiency to ensure lethality. Odyssey is dedicated to excellent contract execution, peak organizational performance, and fostering a workplace built on employee care. Odyssey is proud to live out our core values of commitment, ambition, and respect in our work and communities through OdysseyCares, a philanthropic group focused on giving back through direct donations, an employer match program, and volunteering events. Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Responsibilities

The Clinical Research Coordinator will provide research support for approved protocols, assist with patient recruitment, and ensure compliance with regulatory guidelines. Responsibilities also include maintaining documentation, managing study supplies, and collaborating with the Principal Investigator and research team.