Research Coordinator RN

Job Description

Duties and Responsibilities

Responsibilities:

Administratively and clinically manage industry sponsored clinical trials.

Adhere to Research SOP’s, Good Clinical Practices and Clinical research protocols.

Assist patient recruitment by performing detailed chart reviews and patient interviews.

Conduct the Clinical trial informed consent discussion.

Review of patients’ Medical History against Protocol Inclusion/Exclusion Criteria

Perform blood drawing, processing and shipping blood/urine specimens per study protocol and IATA regulations.

Schedule all patient research visits and procedures consistent with protocol requirements

Receive study medication and appropriately document receipt.

Pull and mix study medications as specified in study protocol.

Collect vital signs and perform ECGs. Assess patients after Infusion, monitor vital signs during and after infusions, and identify and address any adverse reactions Start IVs and assist with study drug infusion as indicated.

Assist with routine data verification and quality control, ensuring data integrity and consistency with defined study protocol.

Ensure filing and maintenance of all regulatory documents.

Schedule and prepare for monitor visits.

Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy.

Qualifications

Associates degree in a clinical or scientific related discipline required, bachelor’s degree preferred.

Current OBN RN license

3+ years previous experience as a Clinical research coordinator or Clinical trial monitor for pharmaceutical phase II or III trials, GI trials preferred.

BLS/ACLS current

Experience with infusion pumps

Excellent IV skills

Excellent assessment skills for patients undergoing study infusion drugs.

Computer skills - Microsoft Word, Excel, Power Point, CTMS, EMR

Previous experience in a role of complex administration or project coordination

Effective communication skills to include written, verbal and presentation skills.

Strong diligence and organizational, analytical, and critical thinking skills

Periodic local travel to other practice locations on an as-needed basis

Physical Requirements

Ability to stand and walk throughout the day.

Prolonged periods of sitting and performing administrative duties including the use of computers.

Ability to bend, twist, stoop, and reach.

Able to lift and carry supplies and equipment as needed (up to fifteen pounds)

Physical Demands

Apply the principles of body mechanics in lifting or moving charts, boxes, or equipment (occasional)

Must be able to independently lift twenty-five pounds (occasional)

Must be able to sit (frequent), stand (frequent), walk (frequent), stoop (frequent), bend over (frequent), and type on keyboard (frequent).

Work Environment

Medical offices require contact with adult patients.

Positive Teamwork skills a must

Full-time