Clinical Research RN - Full time

#REF!•Fort Worth, TX

23h•Onsite

About The Position

This is a full-time Clinical Research RN position at Texas Health Fort Worth. The role involves conducting clinical studies according to FDA, CFR, and ICH regulations and guidelines, from pre-study to closeout. Responsibilities include study startup, ensuring protocol adherence, training staff, educating participants, communicating with sponsors and regulatory bodies, developing recruitment strategies, scheduling visits, performing study activities, completing CRFs, maintaining case histories, documenting adverse events, obtaining informed consent, maintaining study records, and managing clinical supplies and regulatory documentation. The position also requires obtaining and maintaining necessary certifications.

Requirements

Associate’s Degree in nursing required
6 months ICU/CCU/ ER experience or equivalent required
2 years conducting clinical research (drug, devices, etc) required
RN upon hire required
CPR within 30 days of hire and maintained every 2 years

Nice To Haves

Bachelor’s degree in nursing preferred
Clinical Research experience preferred
Research training via CITI (Human subject Protection and Good Clinical Practice) preferred
Epic EMR, Realtime CTMS and SharePoint experience preferred
Dangerous Shipping Goods/Materials Certificate preferred
ACLS upon hire preferred

Responsibilities

Conduct clinical studies according to FDA, CFR and ICH regulations and guidelines: from pre-study to startup to closeout.
Coordinate and facilitate all departments and various organizations to successfully startup a study from feasibility to first.
Be knowledgeable of the Sponsor’s protocol so that all study activities are completed correctly and completely.
Train other site personnel, and medical staff, on the specifics of implementing assigned protocols; including the regulations and expectations of monitors.
Educate participants, families and caregivers regarding protocol requirements and relationship to disease process.
Communicate and meet with the Sponsors, IRBs, Physicians, regulatory bodies, etc. regarding essential study activities as necessary, such as the conduct of the study and review study data.
Promote and represent the CRD in a positive manner.
Develop and implement recruitment strategies for studies; which include screening potential study subjects according to the protocol’s inclusion and exclusion criteria.
Be available to register participants after hours (on call 24 hours a day and on weekends).
Schedule study subjects’ visits and during the study subject’s visit perform defined activities of the study completely and accurately.
Complete the CRFs for the study accurately, completely, and in a timely fashion.
Maintain adequate and accurate case histories for each study subject and record all observations in the source document during the study.
Complete the adverse events source documentation for the sponsor and IRB for review by the Investigator.
Design and maintain organizational tools to conduct studies accurately and in compliance with GCP and ICH guidelines.
Ensure the safety and welfare of the study subjects.
Obtain proper written information consent from each study subject prior to participate in the study.
Maintain all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
Assign study subject numbers and maintain accurate and complete records of the receipt, administration, and return of all clinical supplies (including study drug).
Assist in maintaining all required documentation in the study regulatory documentation file.
Process and complete all IRB documentation, including initial application, Informed Consent, modifications, amendments, Serious Adverse Events, advertisement, etc.
Obtain and maintain certification through appropriate accrediting bodies: (RN, and BLS) As well as certification and training required for studies: GCP, HSP, etc.

Benefits

401k
PTO
medical
dental
Paid Parental Leave
flex spending
tuition reimbursement
student Loan forgiveness
Delivery of high quality of patient care through nursing education, nursing research and innovations in nursing practice.
Strong Unit Based Council (UBC).
A supportive, team environment with outstanding opportunities for growth.