ClinicalRM is seeking a Clinical Research Nurse Coordinator to work at NMCP in Portsmouth, VA.
Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation.
Assign appropriate patient randomization number per protocol design.
Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.
In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol.
Maintain accurate documentation record of drugs received.
Provide education to patients on compliance, possible side effects, drug interactions and importance of contacting the coordinator.
Process and prepare specimens for lab analysis and shipping.
Observe universal precautions and Occupational Safety & Health Administration (OSHA) standards when processing or handling specimens.
Monitor laboratory results and consult with the PI for follow-up care.
Collect data in a timely and accurate manner and submit information to coordinating centers as required.
Report adverse events to governing agencies and sponsors as required by protocol and regulations.
Evaluate compliance of research subject and complete documentation of status and progress.
Conduct telephone, face-to-face interviews or mail information for follow-up visits.
Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Investigator’s File Binder/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 regarding the conduct of the research study.
Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.
Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations.
Perform light duties and other related duties as required and assigned.
Registered Nurse with a Bachelor’s Degree or higher is required.
A minimum of two years experience coordinating research protocols OR certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) (to be used in lieu of the Masters degree requirement).
Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research.
Clinical competence in application of professional nursing theory, practice, and skills for the care of pediatric and adult patients.
Ability to communicate effectively in written and oral modes and to teach in formal and informal settings.
Skills in counseling, guidance and maintaining interpersonal relationships.
Good typing skills to allow online documentation of patient interactions.
Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date.
Knowledge of applicable highly complex scientific/office procedures and techniques relating to position is desirable.
Must be able and willing to travel up to 20%.
Must be able to work independently following a brief period of specific technical training.
Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.
ClinicalRM is an Affirmative Action-Equal Opportunity Employer
Clinical Research Management - 21 months ago
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ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.