Study Activation Specialist
OneOncology
OneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.
Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of community oncologists and the patients they serve.
Job Description:
The Study Activation Specialist is responsible for the coordination and management of the study activation process for oncology clinical trials. The Study Activation Specialist is pivotal in driving the timely and efficient activation of clinical research studies by coordinating and overseeing all aspects of the start-up process across the OneR network. The Study Activation Specialist will work closely with cross-functional teams, including budgeting and contracting, regulatory affairs, and site management, to ensure that all requirements are met and that study sites are fully prepared for patient enrollment. The role requires a thorough understanding of oncology clinical trials and project management principles.
Responsibilities
Manage and coordinate all activities related to the initiation and activation of oncology clinical trials.
Collaborate with budgeting and contracting, regulatory, and site management teams to develop and implement study activation plans.
Coordinate feasibility, site qualification visits and site initiation visits (SIVs).
Manage the collection and review of essential documents from sites.
Serve as a primary point of contact for network sites, providing guidance and support throughout the activation process.
Serve as a primary point of contact for the sponsor, CRO, and vendors.
Facilitate communication between network sites, sponsors, and internal teams.
Conduct regular meetings and provide updates on study activation progress.
Maintain accurate and up-to-date records of study activation activities.
Develop and manage study activation timelines, ensuring milestones are met.
Utilize tracking systems to monitor the status of regulatory submissions, site readiness, and overall study activation.
Ensure sites are prepared for study initiation and patient enrollment.
Cultivate and maintain relationships with various practices within our network to streamline activation processes and promote collaboration.
Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer.
Key Competencies
Strong understanding of clinical trial processes
Excellent organizational and project management skills
Strong attention to detail and ability to handle multiple tasks simultaneously
Effective communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams
Ability to work independently and collaboratively in a fast-paced environment
Qualifications
Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, nursing) required; advanced degree preferred
Minimum of 2-4 years of experience in clinical research, with at least 1 year focused on study start-up/activation in oncology
Proficiency in Microsoft Office applications and familiarity with electronic regulatory binder systems and clinical trial management systems (CTMS) preferred.
Certification in clinical research (e.g., SoCRA, ACRP) is a plus.