Clinical Research Project Manager I - Sarcoma

Dana-Farber Cancer Institute • Boston, MA

6d

About The Position

The Clinical Research Project Manager I is responsible for the day-to-day coordination and management of Sarcoma clinical trial activities, primarily focusing on multi-center, PI-initiated trials. They ensure trial and site startup coordination, train site research staff, handle regulatory submissions, track safety events, and communicate with regulatory authorities. Reporting to disease group managers and/or Clinical Trials Office (CTO) leadership the Clinical Research Project Manager I identifies project plan variances and develops contingency plans to maintain project milestones. They may also oversee operational and training aspects of the EPIC/OnCore application, working closely with faculty, staff, and stakeholders to develop infrastructure, procedures, and tracking systems for project management services. This role requires independent work under general supervision within their disease group or CTO, with a focus on ensuring compliance and efficient trial execution.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
EEO Poster
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Pay Transparency Statement
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

Responsibilities

• Manage the daily operations of assigned clinical trials, ensuring efficient execution and adherence to timelines while maintaining compliance with clinical trial regulations. This involves monitoring budgets, resources, and coordinating with cross-functional teams to meet project milestones.
• Develop and maintain the TMF, ensuring all essential documents are organized, accessible, and compliant with Good Clinical Practice (GCP) standards. Regular updates are conducted to ensure compliance with regulatory standards and institutional policies.
• Assist the Principal Investigator (PI) in developing protocols and consent forms for initial applications and amendments, ensuring they meet regulatory requirements and are easily understood by participants. This requires translating complex scientific concepts into clear, concise documents.
• Initiate, plan, and oversee the start-up, active, and close-out phases of clinical trials, particularly for PI-initiated and multi-center studies. Coordination with stakeholders, including site staff and external partners, ensures smooth transitions between phases and adherence to timelines.
• Design case report forms based on PI directives and maintains study-related databases, ensuring data integrity and compliance with clinical trial standards. Prepare protocol-related reports and data summaries to support ongoing research activities and decision-making.
• Schedule research team meetings and conference calls, facilitate mailings, and perform other project-related administrative tasks to ensure effective communication and coordination among team members and external collaborators.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees