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. 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. The Research Study Associate maintains a comprehensive understanding of federal regulations including study implementation and compliance standards. .
Coordinates activities related to assigned research projects
Supports Director of Clinical Operations and Clinical Research Manager in contracting for specific projects, including industry and institution research contracts and confidentiality agreements
Collects regulatory documents
Assists with planning and facilitating all scientific meetings related to projects including budget, slide and agenda development
Assists with the preparation and distribution of Requests for Proposals (RFPs)
Interprets contracts and assures protocol compliance to Member Institution and Grantor contracts for funded projects
Works with Director of Clinical Operations to oversee ORP metrics, makes recommendations and continuously strives to improve timelines
Performs quality control for assigned research projects
Identifies potential problems and proposes solutions
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
Ensures that all documents and materials related to research projects are complete and current
Main point of contact for investigator and Grantor of assigned projects
Assures that serious adverse events for all studies are reported as required to NCCN, Grantors, and local authorities
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 inquiries related to studies
Works on other ORP projects as assigned (i.e. Annual Meeting Poster Session, Investigator Steering Committee)
Assists with development, maintenance, and updating of SOPs
Travels occasionally as required
Performs other related duties as assigned
Bachelor of Science or advanced degree in related field
3-5 years experience supporting administration of complex research programs
Hospital based or pharmaceutical based clinical or outcomes research experience required
Oncology experience required
Experience with quality outcome measurements, real-world 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
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.
Send resume with salary history to email@example.com. EOE. No calls please.
This position is located in Plymouth Meeting, PA.
About National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of cancer care so patients can live better lives.