Clinical Research RN - Full time

Responsibilities

• Clinical studies according to FDA, CFR and ICH regulations and guidelines: from pre-study to startup to closeout.
• Study Startup: coordination and facilitation of all departments and various organizations to successfully startup a study from feasibility to first.
• 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.
• 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.
• Follows electronic source guidelines and certification and destruction of hard copies, when applicable.
• 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 but not limited to: 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.

Qualifications

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

Benefits

• 401k
• PTO
• medical
• dental
• Paid Parental Leave
• flex spending
• tuition reimbursement
• student Loan forgiveness