Research Study Associate

Make a Difference! Join an organization dedicated to defining and advancing high-quality and accessible cancer care globally so patients can live better lives.
The Research Study Associate is responsible for managing the development, coordination, and implementation of research initiatives at NCCN Member Institutions and other participating sites funded through the Oncology Research Program (ORP). This position oversees study management for assigned research projects, including trial-specific processes and systems, through coordination and communication with research teams at multiple sites. This role will also be a lead support to the Health Equity Report Card pilot project. The Research Study Associate maintains a comprehensive understanding of federal regulations including study implementation and compliance standards.
Requirements
MAJOR RESPONSIBILITIES:

• Maintains detailed records and documentation of all actions and activities related to funded projects
  • Works with appropriate ORP personnel in activities related to assigned research projects
  • Collects regulatory documents and ensures that all documents and materials related to research projects are complete and current
  • Acts as main point of contact for investigator and Grantor of assigned projects
  • Assures that serious adverse events for all studies are reported as required
  • to FDA, NCCN, and Grantors, according to applicable Laws.
  • Assists Clinical Research Manager in monitoring approved studies (quarterly reports, continuing IRB annual reviews, protocol amendments, etc.)
  • Provides financial oversight of assigned projects including distribution of funds to investigators, forecasting payments to investigators, and milestone invoices
  • Responds to and documents inquiries related to studies
• Coordinates activities related to assigned research projects
  • Assists with the execution of the Health Equity Report Card (HERC) Pilot program
    • Manages project milestones and timelines to ensure timely execution
    • Manages REDCap database including content updates, data entry, data analysis, and provides user support for participating sites
    • Provides key support for data analysis of quantitative and qualitative data collected and develops associated reports for review by research team
    • Contributes to authorship of abstracts, conferences presentations, and publications
    • Leads engagement and support with sites remotely and at site visits, acts as primary liaison between sites
  • Assists with planning and facilitating scientific meetings as needed, including budget, slide and agenda development
    • Assists with the preparation and distribution of Requests for Proposals (RFPs)
    • Works with Clinical Research Manager and Director, Oncology Research Program to keep current ORP metrics, makes recommendations and continuously strives to improve timelines
    • Performs quality control for assigned research projects
    • Identifies potential problems and proposes solutions
    • Supports Director, Oncology Research Program, and Clinical Research Manager in contracting for specific projects, including industry and institution research contracts and confidentiality agreements
• Works on other ORP projects as assigned (i.e. Annual Meeting Poster Session, Investigator Steering Committee, HERC)
• Assists with development, maintenance, and updating of SOPs and Office Procedure Manual
• Travels occasionally as required
• Performs other related duties as assigned

EDUCATION/RELATED EXPERIENCE:

• Bachelor of Science or advanced degree in related field or equivalent work experience
• 3-5 years' experience supporting administration of complex research programs as a Study Coordinator, Clinical Research Nurse, Data Manager, Quality Assurance Specialist, Clinical Research Associate (CRA) or Regulatory Affairs Specialist for clinical research studies preferred
• Hospital, pharmaceutical or Clinical Research Organization (CRO) based clinical or outcomes research experience required
• Oncology experience preferred
• Experience with quality outcome measurements, real-world data preferred
• Experience with data management systems eCRFs, or iEnvision preferred
• REDCap experience preferred
• Experience analyzing, coding, and reporting qualitative data preferred

SKILLS AND ABILITIES:

• Excellent written and verbal communications skills
• Strong interpersonal communication skills and the ability to interact effectively with internal and external staff, managers, and physicians at various levels
• Commitment to advancing equitable care systems
• Team player who is self-motivated and can work independently
• Excellent telephone skills
• Organizational ability to manage multiple tasks simultaneously and independently
• Knowledge and understanding of FDA regulations and GCP
• Strong proofreading skills and absolute attention to detail
• Proficient in MS Office products

This position represents a unique opportunity to build a career with a premier organization. We offer competitive salary and excellent benefits.
EOE. No calls please.
This position is located in Plymouth Meeting, PA with the ability to work remotely up to 2 days per week.