Sr. Clinical Research Associate – Boston

Company Information:

Breakthrough Careers!
A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

This position will work with the Manager, Clinical Operations, the Clinical Research Manager and other members of the clinical project team to ensure the execution of assigned clinical trials in accordance with Clinical Operations Plans.

Duties and Responsibilities:

Trains and provides oversight to CRA teams including TCR and trip report review, co-monitoring and mentoring.

Convenes and leads the cross-functional, matrix clinical study team(s) in the planning and execution of clinical trials in accordance with regulatory requirements and standard operating procedures.

Participates in vendor management and vendor budget oversight.

Plans, convenes, runs and presents at investigator meetings.

Contributes to protocol concept, template Informed Consent Form and final protocol development.

Coordinates and provides oversight to site contracting process.

Conducts budget negotiations with sites.

Provides input to patient recruitment strategies and operational feasibility and implementation of clinical trial objectives.

Creates and implements study monitoring plans.

Conducts on-site monitoring and performs site management for assigned sites.

Prepares and ensures the accuracy and appropriateness of study-related reports, manuals and other tools.

Coordinates ongoing study team review of clinical trial data.

Qualifications:

Basic qualifications:

BS/RN/RPh degree with 5+ years of clinical operations experience or MS degree with 3+ years of clinical operations experience including 1+ year of independent site monitoring/management experience.

Preferred qualifications:

Strong site management, site monitoring and clinical operations experience.

Thorough understanding of FDA, ICH, and GCP guidelines as well as a strong understanding of cross-functional clinical processes including data management, biostatistics, and medical writing.

Strong leadership, planning and project management skills.

Good interpersonal and negotiations skills.

Strong verbal and written communications and presentation skills.

Strong problem solving skills with the ability to contribute creative, practical solutions to problems.

Prior CRA oversight responsibility.

Ability and willingness to travel up to 35% of the time (international and domestic).

Willingness to work in different therapeutic areas.


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