Virginia Oncology Associates, the largest group of medical professionals in Hampton Roads and Northeast North Carolina devoted exclusively to cancer care and blood disorders, has an exciting part-time opportunity for a Project Coordinator for our office in Norfolk. This position will require the ability to travel to multiple practice locations. THIS IS A PART-TIME POSITION.
Essential Duties and Responsibilities:
Tracks sponsor-specific queries and resolutions. Works with Regional Regulatory Coordinators to obtain updated documents and/or resolve pending queries.
Assists in processing protocol amendments and/or consent form revisions for assigned trials. Responsible for ensuring new/updated regulatory documentation meets applicable regulations and is submitted to the pharmaceutical sponsor/contract research organization, and/or FDA in a timely manner.
Assists with study-related documents necessitating IRB review throughout the conduct of a trial (protocol amendments, continuing reviews, protocol deviations/exceptions).
Completes critical document collection instructions, as specified for new trials. Maintains and updates internal status log of critical and regulatory documentation completion.
Maintains study-specific and site regulatory files by filing and auditing existing regulatory documentation prior to regularly scheduled monitoring visits and audits.
Participates in early development meetings, conference calls, and discussions concerning the regulatory aspects of a trial in development until the trial is complete.
Bachelor's degree in a clinical or scientific related discipline preferred
Minimum three years related experience in a clinical research setting and/or regulatory affairs
Clinical Research certification (CCRA) preferred
Must be willing to travel between offices as required
The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.
Category: Clinical Research
The US Oncology Network is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Internal Number: MCKEA00878085
About New York Oncology Hematology
New York Oncology Hematology (NYOH) is the leading provider of community-based cancer care and blood disorder services. With seven convenient locations in Albany, Amsterdam, Clifton Park in Saratoga County, Hudson, Rexford and Troy, our team of 32 physicians and 350 cancer care specialists see more than 100,000 cancer visits a year.
NYOH has always been at the forefront of cancer care. More than 30 years ago, we began as the region’s first oncology practice in a community setting (outside a hospital). A few years later, we offered the first radiation treatment outside a hospital setting.
Today, we continue our commitment of providing world class care, close to home. We offer the region’s largest clinical research and drug trial operation, only stem cell transplant program and only neuro-oncology care. We recently brought the first Varian Truebeam Radiotherapy System to our new practice: Clifton Park in Saratoga County.
Our medical staff includes 32 board certified physicians who specialize in the care of patients with cancer (medical oncology and radiation oncology) and blood-related disorders (hematology). With a patient care team of more than 350 oncology certified nurse...s, pharmacists, laboratory technologists, radiation therapists and support personnel, we are able to provide the personal level of care our patients need during treatment.