Clinical Research Project Manager I

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.

About the role

The Clinical Research Project Manager I is responsible for the day-to-day coordination and management of clinical trial activities, primarily focusing on multi-center, PI-initiated trials. This role ensures trial and site startup coordination, trains site research staff, handles regulatory submissions, tracks safety events, and communicates with regulatory authorities. The Project Manager 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 Clinical Trials Office (CTO), with a focus on ensuring compliance and efficient trial execution.

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 Trial Master File (TMF), ensuring all essential documents are organized, accessible, and compliant with Good Clinical Practice (GCP) standards.
• 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.
• Initiate, plan, and oversee the start-up, active, and close-out phases of clinical trials, particularly for PI-initiated and multi-center studies. Coordinate with stakeholders, including site staff and external partners, to ensure smooth transitions between phases.
• Design case report forms based on PI directives and maintain study-related databases, ensuring data integrity and compliance with clinical trial standards. Prepare protocol-related reports and data summaries.
• Provide administrative support by scheduling research team meetings and conference calls, facilitating mailings, and performing other project-related tasks to ensure effective communication and coordination.

Requirements

• Three (3) years of experience in clinical research or project management, ideally within multi-center oncology trials, with specific experience in managing clinical trial operations.
• Bachelor’s Degree relevant to clinical research.

Skills

• Basic understanding of clinical trial processes and regulatory requirements, including Good Clinical Practice (GCP) guidelines.
• Familiarity with trial management software and tools, such as EPIC and OnCore, for efficient trial coordination.
• Awareness of data management practices and documentation standards, with an emphasis on compliance and accuracy.
• Strong organizational and time management skills to handle multiple tasks efficiently, ensuring adherence to clinical trial timelines.
• Effective communication skills for interacting with research staff, stakeholders, and regulatory authorities.
• Basic problem-solving skills to address project-related issues, with the ability to anticipate and mitigate potential challenges.
• Ability to work independently under general supervision, while maintaining compliance with clinical trial protocols.
• Capability to learn and adapt to new procedures and technologies, including updates in clinical trial regulations.
• Competence in maintaining accurate records and documentation, ensuring compliance with regulatory standards.
• Understanding of ethical considerations and patient confidentiality in clinical trials.
• Ability to collaborate effectively with cross-functional teams and external partners to support trial objectives.

Benefits

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. We are committed to having faculty and staff who offer multifaceted experiences.

Pay

$76,910.00 - $85,295.00