Job Details

ChristianaCare is searching for an Oncology Clinical Research Associate to assist with the coordination and organization of 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.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Completes regulatory submissions according to Federal, State, and institutional guidelines as appropriate.

Completes data queries, collection and submission of follow-up data, tracking data submissions and assists in training of new employees.

Prepares 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.

Collaborates with ancillary staff in the requirements for pathology, laboratory, radiation therapy submissions mandated by protocols. Maintains a good working relationship with these departments so that protocol requirements will be met promptly and accurately.

Serves as a resource for questions and problems related to sponsored clinical trials and other clinical oncology research.

Attends educational workshops and seminars as able to maintain current knowledge of cancer treatment trends.

Provides physicians with all pertinent study materials as requested. Assists in maintaining investigator training needed for protocol compliance.

Collects and compiles data retrieved from ongoing clinical trials and submits follow-up case reports, and adverse reaction reports.

Submits 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;

Supports 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. Processes and ships biospecimens as necessary.

Investigates and completes queries or overdue data as dictated by the protocol sponsors.  If unable to resolve query/complete the overdue data then sends the tasks to the responsible research nurse. 

Maintains log/tracks completion of overdue data and queries to ensure timely resolution.

Prepares 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.

EDUCATION AND EXPERIENCE REQUIREMENTS:

High school diploma required with Bachelors preferred in science or related field.

Minimum two years oncology/hematology or research experience required.

When you become an employee at ChristianaCare, you are joining a robust healthcare organization that truly cares about their patients and their caregivers. For the second consecutive year, Forbes magazine has ranked ChristianaCare as one of the best large health systems to work for in the United States! Guided by excellence and love, our Caregivers enjoy a multitude of employee benefits that include:

Full Medical, Dental, Vision and other insurance benefits

403 (b) with an employer match

Diverse and Inclusive culture

Generous paid time off with annual roll-over and opportunities to cash out

12 week paid parental leave

About Christiana Care:

Headquartered in Wilmington, Delaware, 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. ChristianaCare includes an extensive network of outpatient services, home health care, medical aid units, two hospitals (1,227 beds), a Level I trauma center and a Level III neonatal intensive care unit, a comprehensive stroke center and regional centers of excellence in heart and vascular care, cancer care and women’s health. ChristianaCare is 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.

Post End DateOct 31, 2024

EEO Posting Statement

Christiana Care Health System is an equal opportunity employer, firmly committed to prohibiting discrimination, whose staff is reflective of its community, and considers qualified applicants for open positions without regard to race, color, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.