Senior Clinical Research Nurse Professional

6 days ago


Hackensack, New Jersey, United States Actalent Full time
About the Role

We are seeking a highly skilled and experienced Senior Clinical Research Nurse to join our team at Actalent. As a key member of our research team, you will play a critical role in coordinating and overseeing clinical trial operations.

Key Responsibilities
  • Assist principal investigators in preparing proposed clinical trials by reviewing trial protocols and ensuring necessary departments are notified and equipped.
  • Ensure all protocol revisions, informed consents, continuing reviews, and serious adverse events are submitted to the appropriate IRB in a timely manner.
  • Serve as a liaison between principal investigators and sub-investigators on all regulatory issues and protocol changes.
  • Collaborate with principal investigators to review studies for feasibility and potential competition with other protocols.
  • Recruit and evaluate study patients, schedule appointments, and conduct interviews.
  • Identify and address the specific needs of the patient population, including age, culture, and impairments.
  • Review medical records for potential study patients and ensure documentation of all laboratory test results and procedures.
  • Instruct potential study patients, caregivers, and staff on trial aspects, treatments, and side effects.
  • Assist investigators with the consent process and educate study patients on informed consent procedures and HIPAA authorization.
  • Document study patients' medical histories and monitor their progress during clinical trials.
  • Evaluate and develop patient education materials and provide instructions on drug administration and other medical information.
  • Plan for appropriate patient care under the direction of a physician or advanced practice nurse.
  • Notify the principal investigator of any adverse events and serious adverse events, including drug toxicity or side effects.
  • Report all serious adverse events to the sponsor and IRB within established timelines.
Requirements
  • Graduate of an NLN/AACN accredited program in nursing.
  • 3-5 years of clinical nursing experience.
  • Adherence to the American Nurses Association standards.
  • Mandatory education on human subjects research.
Preferred Qualifications
  • BSN degree.
  • Experience with FDA regulatory, IND reporting, and Microsoft Office Suite.
Salary and Benefits

The salary range for this position is estimated to be $105,000 - $125,000 per year, depending on qualifications and experience. We offer a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan.



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