JOB SUMMARY

Under the direction of the Principal Investigator or designee, the Clinical Research Nurse I is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Clinical Research Nurse I is a a member of the team and resource for study protocol conduct acting as a liaison between the SLU SOM, clinical partners (ex. SSM Health), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study.

PRIMARY JOB RESPONSIBILITIES

Review and abstract medical record information and ensure proper adherence to randomization schema, study drug dosing and administration.

Screen patients according to study criteria, randomize, enroll, and obtain consent.

Administratively responsible for scheduling, performing, and/or supervising required study tests.

Perform nursing assessments of study participants.

Document and record, in writing or electronically, all study events and protocol related procedures.

Review clinical system billing charges for accuracy and appropriateness.

Ensure that all required study event(s) and protocol related data are accurately and efficiently entered in the clinical trial management system.

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).

Enters and collects study related data and develops per appropriate processes. Ensures accuracy and completeness of data for all studies. Recognizes and reports security of physical and electronic data vulnerabilities.

Maintains participant-level documentation for all studies, including those that are complex in nature, require access to the EHR or require SLUCare/SSM charge routing. Screen participants for complex studies (e.g., procedural, and interventional studies).

Conducts visits for complex studies (e.g., procedural, and interventional studies).

Identifies all adverse events (AEs) and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require clinical research orders in EHR.

Performs other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES

Proficiency in electronic medical records and relevant computer software.

Strong verbal and written communication skills, and attention to detail is essential.

Ability to work in a team environment to facilitate the integrity of the study and its timely completion.

Ability to travel to off-site locations.

MINIMUM QUALIFICATIONS

RN with current registration to practice nursing in St. Louis.

3-5 years of relevant nursing experience.

Current BLS Certification

Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record).