Director, Study Operations
2 weeks ago
Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 45 therapies that were approved by the FDA. START represents the world's largest roster of Principal Investigators (PIs) across trial sites in the US and Europe. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.
We are hiring for an on site role in our Grand Rapids, Michigan location. The Director, Study Operations is responsible for leading and managing all aspects of clinical research operations to ensure compliance with regulatory requirements, START standards, and Good Clinical Practice (GCP). This role oversees Clinical Research Coordinators, Data Coordination, and Medical Records teams, driving operational excellence and timely study execution.
Hours: Monday through Friday, 8:00am EST to 4:30pm EST
Essential Responsibilities
- Provide leadership and training to Clinical Research Coordinator, Data Coordination, and Medical Records teams to meet site-specific KPIs.
- Ensure timely and accurate data entry, query resolution, and communication with monitors and auditors.
- Maintain compliance with SOPs and participate in Global Quality Management System (QMS) reviews.
- Collaborate with global shared services to support rapid study start-up and activation.
- Facilitate protocol review meetings and ensure accurate data collection in Veeva and other systems.
- Drive process improvements and foster interdepartmental collaboration for operational efficiency.
- Support study acquisition and contribute to strategic planning for research operations.
- Bachelor's degree in a scientific or healthcare-related field (Master's preferred).
- Minimum of 8 years of clinical research experience, including leadership roles.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Proven ability to lead teams and manage complex projects in a fast-paced environment.
- Excellent communication, organizational, and problem-solving skills.
We value our employees' time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including:
- Comprehensive health coverage: Medical, dental, and vision insurance provided
- Robust retirement planning: 401(k) plan available with employer matching
- Financial security: Life and disability insurance for added protection
- Flexible financial options: Health savings and flexible spending accounts offered
- Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided
- Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture.
Ready to be part of a team changing the future of cancer treatment?
Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.
We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
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