Clinical Research Coordinator RN

DESCRIPTION:           

Provides professional nursing care for patients following established policies and procedures and the Virginia Nurse Practice Act.   Develops and maintains accurate procedural methods for research program. Is self-motivated with the ability to work independently under minimal supervision. Maintains strict confidentiality of sensitive issues.

DUTIES AND RESPONSIBILITIES:

• Works collaboratively with all members of the clinical research team to assure studies are conducted within protocol defined specifications.
• Professional communication with study sponsors and staff, assisting with site feasibility surveys, regulatory/ compliance, start up and closeout activities.
• Uses internal systems, EMR/EMP and Microsoft Word to create study specific source documents for review by sponsors as well as documents required for IRB submission.
• Tracking and logging of investigational products with the responsibility of maintaining inventory as well as compliance of research participants.
• Creating and maintaining study communication, regulatory binders and associated logs.
• Screening electronic medical records (EMR) for potential study candidates and tracking efforts.
• Recruit and consent patients with assessment of protocol inclusion and exclusion criteria.
• Works closely with PI and sub I’s to ensure appropriate candidates are selected to participate in individual studies.
• Keeps PI and Sub I’s apprised of patient progress and of any AE’s SAE’s experienced.
• Meets with sponsor representatives on a regular basis for study monitoring and training.
• Maintains adequate inventory of supplies for multiple studies.
• Performs various nursing procedures to meet study qualifications.
• Able to perform venipuncture for lab work or IV access independently.
• Able to develop study specific source documents while capturing requirements of individual protocols.
• Extrapolates data points from EMR and paper source documents and enters accurately into electronic data capture systems.
• Provides education and support to patients.
• Develops and maintains standards of practice and good clinical practice guidelines within industry standards and FDA requirements.
• Maintain all clinical research documentation that is required.
• Able to provide quality care and maintain protocol between multiple studies.
• Travel to required research study meetings.
• Working knowledge of current health care practices and clinical theory.
• Follows standards for Universal Precautions as well as IATA guidelines.
• Provide clinical information to other departments at Selma Medical Associates, Inc. as requested.
• Responds and assists with emergency situations in the office
• Serves as patient advocate
• Other duties as assigned

QUALIFICATIONS:       

• Graduate of accredited school of nursing.
• Must possess a current Nursing License from the Commonwealth of Virginia.
• CPR certification (BCLS required).
• Detail oriented.
• Excellent oral and written communication skills with the ability to work independently and as a member of a team.
• Ability to plan and execute tasks and projects while maintaining flexibility and communication. Strong organizational skills are a must.
• Ability to work effectively within sponsor required study timelines.
• Able to create and maintain detailed records (paper and electronic).
• Schedule flexibility for overtime and weekends on an as needed basis.
• Must have a working knowledge of current health care practices and nursing theory.  Oral and written communication skills.  Skilled in client assessment and problem solving.  Ability to interpret and follow current guidelines and polices.  Skill in organizing and coordinating patient care.
• Good logical and analytical skills.
• Computer literate. Flexible personality.
• Able to multitask between projects
• Minimum of 3 years clinical research experience or comparable training/ certification.
• Ability to understand that unauthorized discussion and/or disclosure of protected health information (PHI) in any form, either on or off the premises of Selma Medical Associates, Inc. is strictly forbidden.
• Understanding that Privacy and Security of medical records is covered by the Privacy Act of 1974 and Federal Regulation 45 CFR, Parts 160, 162 and 164 Standards for Privacy & Security of Individually Identifiable Health Information.