Biomea Fusion’s Contract Sr. Clinical Research Associate will work with Biomea’s Clinical Program Managers to support and manage the company’s clinical trials. The Sr. Clinical Research Associate will take on a broad range of clinical trial responsibilities and interact extensively with Biomea’s clinical team, as well as its consultants and CROs. This is an onsite role.
- Ensure the success of Biomea Fusion’s clinical trials through close cooperation with Biomea’s Clinical Operations Managers and CROs
- Participates in CRO or vendor selection. Ability to participates or effectively conducts meetings with CROs, vendors and cross-functional teams.
- Ability to develop tools and processes that increase measured efficiencies of the project
- Ability to anticipate potential risks and proactively develop mitigation plans or solutions to achieve project goals and timelines
- Support clinical team efforts to contribute to regulatory submissions in the US and globally by reviewing and coordinating approvals of clinical
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Assist in review of project budgets and ensures tasks, deliverables are within scope
- Ability to prioritize multiple tasks, plan proactively and accomplish goals using well-defined instructions and procedures.
- Assist in the creation and coordinate approvals of Biomea’s generated clinical trial documentation, including protocols, informed consent forms, and clinical study reports
- Review of CRO‐created documents such as monitoring plans and reports, source document worksheets, and case report forms
- Build GCP compliance into each trial via assisting CROs and Biomea’s clinical staff site query resolution, minimizing protocol deviations, writing/following SOPs, and auditing study procedurs
- Work closely with CROs and other vendors to manage study electronic Trial Master Files (eTMFs) from study start‐up through closeout, including audits as necessary
- Ability to manage vendors independently
- Assist with Investigator meeting preparations, including the creation of training materials for both CROs and investigative sites, and help coordinate the investigator meeting planning and logistics
Education and Experience Requirements:
- A BA or BS in biological sciences, nursing, or related field is preferred.
- At least 3-5 years of relevant clinical operations experience are required.
- Experience monitoring clinical trial sites and experience with oncology and/or diabetes trials and studies using patient reported outcomes are a plus but are not required.
- Thrives in a dynamic start‐up
- Flexibility to wear multiple hats as
- Works well in a team environment but can also work independently without significant oversight
- Strong project management skills
- Thorough knowledge of GCP
- Ability to interact with all levels of staff to coordinate/execute study activities
- Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
Equal Employment Opportunity:
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.