RN Clinical Research - Roper St Francis Healthcare

Location: Research & Innovation Alzheimers Research Bon Secours St. Francis Hospital Charleston SC

Shift: Day shift 8:00am5:00pm

Primary Function/General Purpose of Position

The RN Clinical Research ensures the veracity and quality of clinical trials are maintained and conducted in accordance with federal state and local regulations including IRB approvals. This position is primarily responsible for the accurate completion of study visit procedures and collection of information from study subjects according to protocols and for protecting the health safety and welfare of research participants while acting as an advocate for research subjects. The nurse will be active in the promotion education and enrollment of participants to clinical trials. Maintains accurate patient records and organized filing system. Provides data management for all research subjects who are on study and in followup. Monitors data for trends protocol violations or other patterns that may require action. Prepares for research base audits and assists with regulatory requirements. Submits required data forms to the appropriate groups including but not limited to other hospital departments and research groups within the required time frame.

Essential Job Functions

• Coordinates research studies in a team approach per study protocol meeting protocol guidelines and all applicable IRB and FDA regulations. Reviews research protocols prior to study initiation. Collaborates with all members of research team in developing and implementing strategies for the effective management of research studies. Coordinate with research physicians and other study staff for timely completion of all study activities.

• Ensures compliance with each study protocol by providing thorough review and documentation at each study visit for every subject.

• Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine compliance with eligibility requirements.

• To ensure accuracy and completeness of patient records:

a. Maintains an organized filing system

b. Provides accurate and complete data management for all research patients on study and in followup

c. Monitor data trends protocol violations or other patterns that may require action.

• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods practices and procedures for all research activities. Supports the regulatory staff in the maintenance of regulatory documents.

• Provides accurate and timely data collection documentation and entry.

• Maintains subject research records through the creation of source documentation. Transcribes data collected into applicable study documentation completely and accurately. Records all research subject activities to facilitate the tracking of sponsor payments.

• Communicates study specific requirements to and collaborates with the research study team including internal and external parties sponsors monitors investigators and study participants.

This document is not an exhaustive list of all responsibilities skills duties requirements or working conditions associated with the job. Employees may be required to perform other jobrelated duties as required by their supervisor subject to reasonable accommodation.

Licensing/Certification

• Currently licensed as a Registered Nurse in the state of South Carolina or holds a current compact/multistate license as a Registered Nurse in a recognized NCSBN Compact State and is not a permanent resident of SC.

• Must have a current American Heart Association BLS for Healthcare Provider Card.

• Valid SC drivers license with a good driving record

Education

• Bachelors degree in Nursing from an accredited college/university (required)

• For teammates hired into this position prior to December 20 2022 must have an ADN from an accredited school or college of nursing (required)

Work Experience

• Experience/ knowledge in disease prevention education risk assessment screening programs and physical examination (required)

• Minimum of two years experience in clinical research trials may include unpaid internship experience (required)