Clinical Research Nurse

Company: Actalent
Location: Hackensack
Posted on: May 23, 2025

Job Description:

Job Title: Clinical Research NurseJob DescriptionWe are seeking a dedicated Clinical Research Nurse to coordinate and oversee clinical operations of clinical trials, while participating in the assessment, planning, implementation, and evaluation of patient care within clinical research studies.Responsibilities

• Assist the principal investigator in preparing proposed clinical trials by reviewing trial protocol and coordinating with departments providing resources.
• Ensure timely submission of protocol revisions, informed consents, continuing reviews, and serious adverse events to the appropriate IRB.
• Act as a liaison between principal investigators and sub-investigators on regulatory issues and protocol changes.
• Collaborate with principal investigator to review study feasibility and evaluate potential competition before submission.
• Review studies with principal investigator for budget preparation, outlining standard care and research costs.
• Recruit and evaluate study patients, schedule appointments and interviews, and modify care to meet patient needs.
• Review medical records for potential study patients, ensuring documentation of laboratory results and study progress.
• Instruct patients, caregivers, and staff on patient care, available trials, treatments, and side effects.
• Assist investigators with the consent process, educating patients on clinical trials and obtaining written informed consent.
• Document patients' medical history, including past medical/surgical treatments and medication history.
• Perform nursing assessments and monitor progress during clinical trials, documenting responses on flow sheets.
• Develop patient education materials and provide instructions on drug administration, creating study-specific calendars.
• Plan appropriate care under the direction of a physician or advanced practice nurse.
• Notify principal investigator of adverse events and serious adverse events, including drug toxicity or side effects.
• Report serious adverse events to sponsor and IRB according to established timelines.
• Coordinate research activities, including scheduling laboratory tests, radiology testing, and medical exams.
• Perform and oversee clinical duties such as EKGs, processing/shipping of blood serum, and communication of results.
• Act as principal investigator's representative in communication with sponsors, IRB, and medical personnel.
• Maintain accurate, complete, up-to-date records for each patient in clinical trial protocol.
• Ensure appropriate billing for clinical trial activities and reconcile drug study account records with research finance.
• Prepare and assist for sponsor monitor site visits, ensuring adequate supporting documentation.
• Develop case report forms and databases for physician-initiated studies as needed.
• Assist the principal investigator in preparing for publication and work with analysts on data queries.
• Provide education to departments and clinical areas where the study is performed.
• Attend research meetings and conferences as required.
• Participate in staff meetings and in-service education for nursing and medical staff.
• Adhere to standards identified in the Medical Center's Organizational Competencies.Essential Skills
  • Graduate of a NLN/AACN accredited program in nursing.
  • Minimum of 3-5 years of clinical nursing experience.
  • Adherence to American Nurses Association standards.
  • Mandatory education on human subjects research.
  • Clinical Research Experience or Oncology Certified Nurse (OCN) certification, with 2-5 years of experience.Additional Skills & Qualifications
    • BSN degree preferred.
    • Knowledge of FDA regulatory processes and IND reporting.
    • Proficiency in Microsoft Office Suite or similar software.
    • Experience in oncology or clinical research.
    • NJ State Professional Registered Nurse License preferred.Work EnvironmentThe work environment is fast-paced and high-pressure, requiring effective performance in a diverse and accepting team. Flexible work hours are offered, with most opting for four 10-hour days. Initially, the first 90 days involve a Monday-Friday schedule with an 8-hour shift, after which 4-hour days are based on coverage and tenure. Candidates must be able to thrive in this dynamic setting.Pay and BenefitsThe pay range for this position is $139000.00 - $139000.00/yr.HMH perm benefits upon start dateWorkplace TypeThis is a fully onsite position in Hackensack,NJ.Application DeadlineThis position is anticipated to close on May 27, 2025.About ActalentActalent 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. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Keywords: Actalent, Norwalk , Clinical Research Nurse, Healthcare , Hackensack, Connecticut