Oncology Clinical Research Associate

4 days ago

Newark, Delaware, United States Christiana Care Full time
Job Summary

ChristianaCare is seeking a highly skilled Oncology Clinical Research Associate to join our team. As a key member of our research team, you will be responsible for coordinating and organizing all aspects of clinical research activities per study protocols and FDA GCP guidelines. This will include the management of protocol details, regulatory submissions, and audit preparations.

Key Responsibilities:
  • Complete regulatory submissions according to Federal, State, and institutional guidelines as appropriate.
  • Complete data queries, collection and submission of follow-up data, tracking data submissions and assist in training of new employees.
  • Prepare documents for submission to IRB for any protocol amendments that require IRB approval. This may require amending the consent form as well at the delegation of the regulatory research nurse.
  • When needed acquire signatures from investigators for IRB/regulatory documents necessary for adherence to protocol guidelines.
  • Collaborate with ancillary staff in the requirements for pathology, laboratory, radiation therapy submissions mandated by protocols. Maintain a good working relationship with these departments so that protocol requirements will be met promptly and accurately.
  • Serve as a resource for questions and problems related to sponsored clinical trials and other clinical oncology research.
  • Attend educational workshops and seminars as able to maintain current knowledge of cancer treatment trends.
  • Provide physicians with all pertinent study materials as requested. Assist in maintaining investigator training needed for protocol compliance.
  • Collect and compile data retrieved from ongoing clinical trials and submit follow-up case reports, and adverse reaction reports.
  • Submit follow-up information as specified by protocol. Long-term survival follow-up may require extensive time acquiring medical records from other physician offices, patient and/or family contact, or correspondence with regulatory agencies to acquire knowledge about the patient's survival status. This will require travel to physician offices;
  • Support the conduct of clinical trials, including travel to physician offices to obtain samples (urine, blood, etc.) as required by protocols, deliver study drug, obtain participant records from physician/hospital charts. Process and ship biospecimens as necessary.
  • Investigate and complete queries or overdue data as dictated by the protocol sponsors. If unable to resolve query/complete the overdue data then send the tasks to the responsible research nurse.
  • Maintain a log/tracks completion of overdue data and queries to ensure timely resolution.
  • Prepare for protocol audits and site visits. Responsible for reviewing charts, assuring that all information is up-to-date, and documentation of all data is available and that each patient has signed an IRB-approved consent.
Requirements:
  • High school diploma required with Bachelors preferred in science or related field.
  • Minimum two years oncology/hematology or research experience required.
About ChristianaCare:

ChristianaCare is one of the country's most dynamic health systems, centered on improving health outcomes, making high-quality care more accessible and lowering health care costs. We are a not-for-profit teaching health system with more than 260 residents and fellows. We are continually ranked by US News & World Report as a Best Hospital. With our unique, data-powered care coordination service and a focus on population health and value-based care, ChristianaCare is shaping the future of health care.

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