Senior Clinical Trial Associate

About the Role >>> Senior Clinical Trial Associate

As the Senior Clinical Trial Associate reporting to the Senior Manager, Clinical Trial Leader, you will provide Clinical team members project-specific administrative support related to the department and conduct of all types of clinical trials. Responsibilities include assisting with study team activities, performing administrative clerical duties, obtaining study materials, and updating invoices and clinical study trackers. This position adheres to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines.

This is a fantastic opportunity for a motivated CTA to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women's oncology company with significant potential to transform breast cancer treatments.

This role is based out of either our office San Francisco or Cambridge office and will require approximately 10-25% travel.

Your work will primarily encompass:

• Performs support for study team(s) in ensuring ongoing accurate and essential documentation of study conduct.

• Manage study-related vendors and serving as a point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics.

• Conducts reconciliation and tracking of study processes in collaboration with study team and escalates issues in a timely fashion to study lead.

• Assists in contacting vendors and investigator sites to provide/extract study-specific information.

• Ensures receipt, completeness, accuracy, and appropriate filing of clinical and administrative documents.

• Coordinates distribution and shipment of study-related materials.

• Coordinates vendor and investigator site payments as needed (tracking of invoice and payments).

• Facilitates flow and maintenance of correspondence with vendors and sites.

• Manages and tracks contracts, invoices, and budgets.

• Conducts periodic quality control reviews and records reconciliation of the Trial Master File (TMF).

• Assists in coordination of study initiation documentation materials.

• Performs study and departmental administrative and clerical duties such as agendas and minutes for team meetings and meeting planning and support. Assists with preparation of presentation materials and other duties as required.

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• Bachelor's degree is required.

• Research or health care related academic or work experience required.

Experience:

• At least three years of related industry experience.

• Senior CTA requires 2 years' experience working as a Clinical Trial Associate.

• Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook).

• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines is preferred.

• Experienced with leading small group meetings and/or managing vendor relationships.

• Working knowledge of ICH/GCP regulations.

• Working knowledge of clinical protocols.

• Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed.

Attributes:

• Highly motivated and enjoys working in a fast-paced, dynamic environment.

• Excellent teamwork and collaboration skills.

• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.

• Positive, flexible, self-starter, and thrives under pressure.

• Excellent written and verbal communication skills.

The base pay range for this position is expected to be $105,000 - $111,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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