Oncology Clinical Trials Coordinator

6 days ago

New Brunswick, New Jersey, United States Vitalief Full time
About Vitalief

Vitalief is a leading research and clinical trial solutions company dedicated to identifying and partnering with talented clinical research professionals to support our clients in planning and executing successful clinical trials.

Job Summary

We are seeking a highly skilled Clinical Research Nurse to join our team. As a Clinical Research Nurse, you will be responsible for the implementation of Oncology Phase 1 related clinical trials at our Clinical Research Center (CRC) and ensuring that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines and other applicable standard operating procedures and guidelines.

Key Responsibilities
  • Assist investigators to prepare and implement new clinical trials, screens and enrolls study participants, and provide protocol-related clinical management to those participants while on study.
  • Ensure successful, patient-oriented, safe, and effective conduct of clinical trials.
  • Serve as a resource to other staff members on available protocols, and general research topics such as FDA, IRB and GCP regulations.
  • Collaborate with Protocol Activation office to initiate and activate all new clinical trial protocols assigned utilizing Oncore Study-start up task list.
  • Collaborate with the clinical research team to ensure timely prescreening of potential subjects and or active cancer patients for all available clinical trials.
  • Reviews patient's charts and medical history to confirm protocol eligibility and obtains source documents (i.e., medical record documentation) as needed.
  • Proactively manages, coordinates, and delivers high-quality, compassionate hands-on competent oncology nursing care and coordinates with the assigned clinical team, investigators, and ancillary departments (such as pathology, radiology, clinical laboratory, surgery, infusion services) as per protocol requirements and ensures adherence to the treatment plan and GCP guidelines.
  • Complete Serious/Unexpected Adverse Event (SAE) form for all internal and multicenter serious/unexpected adverse events as required by study sponsors, federal requirements, and institutional guidelines. Ensures accurate completion of SAE follow-up reports and that physician attribution has been included in all AE reports.
  • Demonstrate basic knowledge to accomplish core tasks (SAE completion, access protocol attachments via OncoreTM, enter charts into Medical Records Database, format, and print patient study calendars).
Requirements
  • Graduate of an accredited school of nursing with a license to practice in the State of New Jersey.
  • Bachelor's Degree in Nursing preferred. Equivalent education, experience and/or training may be substituted for the degree requirement.
  • Two or more years of nursing experience working in a hospital setting.
  • Minimum of 1 year or more years of experience working in an Oncology specialty area in a hospital or clinic setting.
  • Minimum of 6 months clinical research nursing experience.
  • Maintains active Basic Life Support (BLS) certification.
  • Must possess excellent communication and interpersonal skills to interact with subjects in a clear and confident manner.
  • Must be capable of independent decision-making, and multitasking.
  • Must be passionate in initiating, developing, and managing long term relationships with patients and networks; encourage collaboration and input from all team members; and value the contributions of all team members.
  • Ability to gather relevant information systematically; break down problems into simple components; make sound decisions.
  • Passionate about approaching problems with curiosity and open-mindedness; offer new ideas, solutions and/or options.
  • Proficient in computer applications (i.e., OncoreTM, Word, Excel, medical records database systems, etc.).
Physical Demands

Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25lbs.

Important Note

Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.

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