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Under the direction of the Principal Investigators and Oncology Research Program Manager, tasks include, but are not limited to:
1. Read and understand protocols and assists in coordinating subject’s visits according to protocol requirements
2. Clearly and concisely document or enter data in Electronic Data Capture systems from subject assessments, test results and other required protocol information
3. Assist in screening and recruiting potential subjects through review of patient medical charts and attending tumor boards and conferences
4. Obtain informed consent from patients according to Cape Cod Hospital’s Standard Operating Procedures, federal and Institutional Review Board guidelines for minimal risk protocols
5. Assist in scheduling and conducting subject visits per protocol requirements
6. Administer protocol required questionnaires
7. Perform various administrative duties, which may include assistance to subject with specimen collection and delivery to CCH lab and shipping of lab samples
8. Interact and correspond with internal and external constituents including sponsors, cooperative groups (National Cancer Institute’s Alliance and NRG Oncology), Institutional Review Board and regulatory agencies
9. Accurately complete source documentation and Case Report Forms
10. Comply with HIPPA regulations and Confidentiality Agreements with sponsors/Clinical Research Organizations
11. Promptly report Adverse Events and Serious Adverse Events per protocol
12. Assist with monitoring and reconciling research charges while complying with federal and institutional guidelines
13. Maintain documentation of personal professional development activities
14. Consistently provide service excellence to all patients, family members, visitors, volunteers and co-workers
15. Perform work-related duties and activities as assigned or requested by immediate supervisor
16. Challenges current working practices; identifies process improvement opportunities and presents recommendations and solutions to management. Engages and commits to the organization’s culture of continuous improvement by actively participating, supporting, and promoting CCHC Pillars of Excellence.
• Must read, write and communicate in English
• Associates degree preferred or equivalent combination of experience and education
• Previous research coordination, data management, and patient recruitment experience preferred
• Physician and interdisciplinary collaboration experience preferred
• Excellent communication skills
• Ability to manage documents and data electronically utilizing tools such as research sponsor data portals and Microsoft Office software including Outlook email, Word and Excel
• Excellent organizational skills required
• Knowledge of medical terminology, an emphasis in oncology preferred
• Capable of working with terminally ill patients and their families
• Collaborative Institutional Training Initiative (CITI) research certification within 1 month of hire
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