Clinical Research Nurse Specialist

4 days ago

Hackensack, New Jersey, United States Actalent Full time
Job Overview

We are seeking a dedicated and experienced Clinical Research Nurse to join our team. This role involves assessing, planning, implementing, and evaluating patient care in clinical research studies under the supervision of the principal investigator.

Responsibilities
  • Assist the principal investigator 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.
  • Act as a liaison between principal investigators and sub-investigators on all regulatory issues and protocol changes.
  • Collaborate with the principal investigator 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.
  • Coordinate research activities, including scheduling laboratory tests and other medical exams.
  • Perform or oversee clinical duties such as EKGs, processing/shipping of blood serum, and communicate results to the PI and/or APN.
  • Act as the principal investigator's representative as needed, including communication with sponsors and medical personnel.
  • Maintain accurate and up-to-date records on each patient participating in a clinical trial protocol.
  • Ensure clinical trial-related activities are billed appropriately and reconcile drug study account records with research finance personnel.
  • Prepare for sponsor monitor site visits and ensure all supporting documentation is available.
  • Develop case report forms and/or databases for physician-initiated studies as needed.
  • Assist the principal investigator in preparing for publication and evaluating collected data.
  • Provide education to all departments and clinical areas where the study is performed.
  • Attend research meetings and conferences as required.
  • Participate in staff meetings and in-service education of nursing and medical staff.
  • Adhere to the standards identified in the Medical Center's Organizational Competencies.
Essential Skills and Qualifications
  • 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.
Additional Skills and Qualifications
  • BSN degree preferred.
  • Experience with FDA regulatory, IND reporting, and Microsoft Office Suite.
  • NJ State Professional Registered Nurse License required.
Compensation and Benefits

The estimated annual salary for this position is $110,000-$130,000. Flexible work hours are available, with most employees working 4 days of 10-hour shifts. The team is diverse and welcoming to hard workers, creating an incredible and accepting environment.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

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