The Clinical Research Project Manager is responsible for the day-to-day coordination and management of Breast Oncology 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 faculty, research and/or 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.

• Day-to-Day Project Oversight: 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.
• Trial Master File (TMF) Development and Maintenance: 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.
• Protocol and Consent Form Development: 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.
• Clinical Trial Phases Management: 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.
• Case Report Form Design and Database Maintenance: 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.
• Administrative Support: 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

KNOWLEDGE, SKILLS & ABILITIES:

• 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.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in a field relevant to clinical research.
• Required 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.
• Preferred experience in an academic institution with a proven track record of success in the clinical research field is preferred, particularly in roles involving clinical trial coordination and management.

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).

$76,910.00 - $85,295.00