Clinical Research Coordinator

About the role

Culmen International, LLC is hiring a Clinical Research Coordinator to assist the Naval Medical Center in Portsmouth, VA. This position will support the Department Head of CID and is accountable for research related matters to the PIs of each research protocol.

Responsibilities

• Coordinate research activities of assigned IRB and IACUC-approved study protocols, such as IRB pediatric and adult studies or IACUC animal studies.
• Supports the Department Head of CID and is accountable for research related matters to the PIs of each research protocol.
• Ensure all studies performed are in accordance with the approved protocol and applicable local, state, and federal regulations.
• Work closely with the Senior Research Technician/Supply Purchase officer in identifying the study materials, equipment and/or research animals needed in the research protocol and in accordance with CID IACUC policies and animal facility standard operating procedures.
• Auxiliary duties include assisting with recruiting and screening patients using protocol inclusion/exclusion criteria and referring eligible patients to the PI for final evaluation.
• Auxiliary duties also include assisting Government personnel with ensuring the consent process has taken place effectively and all questions are answered satisfactorily and documented.
• Auxiliary duties include assisting with providing education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator.
• Auxiliary duties include assisting with coordinating the performance of phlebotomies, electrocardiograms, initiating intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol.
• Auxiliary duties include maintaining proficiency required to coordinate clinical research such as communication skills and leadership skills as the coordinator of complex human and animal research protocols.
• Auxiliary duties include maintaining proficiency in appointment booking, and coordinating laboratory studies, x-rays, and other tests.
• Auxiliary duties include assisting with assigning appropriate randomization number, per protocol design, to subjects.
• Auxiliary duties include assisting the Research Pharmacist with ensuring that drugs are correctly dispensed as per protocol.
• Auxiliary duties include assisting with maintaining accurate documentation record of drugs received.
• Auxiliary duties include processing and preparing specimens for lab analysis and shipping.
• Auxiliary duties include observing universal precautions and OSHA standards when processing or handling specimens.
• Auxiliary duties include collecting laboratory results and consulting with the PI for follow-up care.
• Auxiliary duties include ensuring collection of data in a timely and accurate manner and submitting information to coordinating centers as required, subject to final Government approval.
• Auxiliary duties include ensuring reporting of adverse events to the governing agencies (IRB/IACUC) and sponsors as required by protocol and regulations.
• Auxiliary duties include ensuring the research study is in accordance with regulations and standard operating procedures, to include complete documentation of status and progress.
• Auxiliary duties include assisting with maintaining detailed documentation of the research study as required by the protocol and the PI’s File Binder/Regulatory Binder.
• Auxiliary duties include assisting with preparing reports and other correspondence regarding the research protocol for IACUC, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol, subject to final Government approval.
• Auxiliary duties include assisting with producing protocol amendments and continuing reviews in the eIRB system, subject to final Government approval.
• Auxiliary duties include submitting deviation study reports to the IACUC/IRB, subject to final Government approval.
• Auxiliary duties include attending conferences and other meetings as required by the protocol, the PI or sponsoring agency.

Requirements

• Bachelor's Degree
• 2 Years of Experience
• Ability to obtain a Secret Clearance

Qualifications

• Ability to work independently and as part of a team
• Strong organizational and time management skills
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office Suite
• Knowledge of Good Clinical Practice (GCP) guidelines
• Experience with electronic health records (EHR)
• Experience with regulatory submissions and compliance

Skills

• Research coordination
• Study protocol management
• Documentation and record-keeping
• Adverse event reporting
• Protocol amendments and continuing reviews
• Communication and interpersonal skills
• Time management and organization
• Microsoft Office Suite
• Good Clinical Practice (GCP) guidelines
• Electronic Health Records (EHR)
• Regulatory submissions and compliance

Benefits

Exceptional Medical/Dental/Vision Insurance, premiums for employees are 100% paid by Culmen, and dependent coverage is available at a nominal rate (including same or opposite sex domestic partners).

Pay

Salary range: $60,000 - $80,000 annually

Schedule

Full-time, Monday through Friday, 8:00 AM - 4:30 PM