Registered Nurse - Clinical Research Coordinator

It's more than a career, it's a calling

MO-SSM Health Saint Louis University Hospital 1201 Grand

Worker Type:

Regular

Job Highlights:

• Registered Nurse - Clinic!
• Monday - Friday 8-4:30pm!
• No Nights, No weekends, No on-call!

Job Summary:

Carries out assigned phases of investigational clinical studies according to guidelines set forth by the FDA, the IRB (institutional review board), principal investigator(s), and specific stakeholders.

Job Responsibilities and Requirements:

PRIMARY RESPONSIBILITIES

• Coordinates clinical studies in the medical research area.
• Develops an understanding of the requirements of the study protocol and obtains necessary information from physicians and study participants and records this information appropriately. Adheres to protocol in all situations.
• Responsible for recruitment, screening, interviewing and evaluating of study participants.
• Develops advertisement copy and recruitment plan for recruiting study participants. Responsible for development, completion, accuracy and maintenance of patient forms, including the Informed Consent.
• Completes or oversees completion of data entry in a timely manner. Ensures that drug dispensing is performed according to protocol, documented on inventory forms/electronic records, and maintained and updated regularly.
• Responsible for reconciling drug supplies with drug records, for assuring that the study site has adequate drug, biological and other supplies, and for distribution of such to designated individuals.
• Reports all adverse events via appropriate documentation and follows up on incidents.
• Reviews and maintains updated regulatory binder. Responds to quality assurance audit reports in time period required.
• Monitors patient safety, compliance and health status.
• Anticipates study problems, formulates solutions and determines resolutions.
• Responsible for all aspects of study termination, i.e. completes necessary documents/forms, return of drugs to drug company, etc.
• Develops and maintains communication with the research manager, co-workers, principal investigators, and other internal personnel regarding study related issues.
• Prepares for and meets with pharmaceutical monitors’ site visits. Maintains professional relationships with external customers.
• Participates in department staff meetings, study planning and special projects as appropriate.
• Attends and participates in investigator meetings as required by pharmaceutical companies.
• Communicates necessary information with sponsors, monitors, patients, physicians, co-workers, and others in a courteous and professional manner.
• Exhibits an ability to work in a collaborative, effective manner with all necessary research team members in order to meet the research objectives. Serves as a liaison between physicians, drug companies, research organizations, staff and patients.
• Develops and maintains professional communication with monitors, sponsors, and potential sponsors in such areas as initiation visits, monitor visits, investigator meetings.
• Works in a constant state of alertness and safe manner.
• Performs other duties as assigned.

EDUCATION

• Graduate of accredited school of nursing

EXPERIENCE

• One year registered nurse experience

PHYSICAL REQUIREMENTS

• Frequent lifting/carrying and pushing/pulling objects weighing 0-25 lbs.
• Frequent sitting, standing, walking, reaching and repetitive foot/leg and hand/arm movements.
• Frequent use of vision and depth perception for distances near (20 inches or less) and far (20 feet or more) and to identify and distinguish colors.
• Frequent use of hearing and speech to share information through oral communication. Ability to hear alarms, malfunctioning machinery, etc.
• Frequent keyboard use/data entry.
• Occasional bending, stooping, kneeling, squatting, twisting and gripping.
• Occasional lifting/carrying and pushing/pulling objects weighing 25-50 lbs.
• Rare climbing.

REQUIRED PROFESSIONAL LICENSE AND/OR CERTIFICATIONS  

Resuscitation Certification Requirement: Basic Life Support Healthcare Provider (BLS HCP) required within 90 day of employment. Other resuscitation certifications may be required dependent on department.