• Study Coordinator, Nonclinical Studies

    Job Locations US-MA-Bedford
    ID
    2019-1070
    Category
    Toxicology / BioAnalytical
    Type
    Full Time Salary
  • Overview

    This role is responsible for the management of the conduct of nonclinical studies and associated activities by interfacing with the contract research organizations (CROs) to provide study designs, obtain project estimates, monitor studies, develop protocols and review reports. Responsibilities include identification and onboarding of CRO, interfacing with internal cross-functional teams to align activities for support of all studies, and to provide study and timeline updates to project team members. The Study Coordinator is responsible for both GLP and non-GLP research and safety studies and supports both the Toxicology and External Research functions. This position will report into the Head of Toxicology.

    Responsibilities

     

    • Work with the head of Toxicology, and the head of External Science to support nonclinical efficacy, biodistribution and toxicology studies for AAV vectors
    • Interact directly with external Study Directors and other key personnel at multiple Contract Research Organizations (CROs) for study coordination and planning, protocol development, research report review, and project timelines.
    • Monitor outsourced nonclinical studies through regular communications with external Study Directors and interim data reviews and communicate updates to the project team.
    • Contribute to tactical resolutions to scientific challenges (e.g. dose level selection, study design optimization, data interpretation) and troubleshooting.
    • Conduct critical research report reviews, in conjunction with other team members, and provide comments to the external Study Director, and coordinate report finalization.
    • Assist in the qualification and selection of nonclinical CROs to support the nonclinical program
    • Co-ordinate shipment of animals, critical reagents, test article and samples between sites to facilitate studies
    • Arrange for archival of study materials after finalization
    • Assist in data analysis from studies by preparing Excel and Powerpoint files
    • Assist in obtaining quotes from CROs for pending nonclinical studies or support services including providing detailed study designs for RFPs.
    • Work with Legal and contracts manager to ensure MSA, NDA, SOW, and POs are in place and tracked properly
    • Lead activities to ensure completion of all project milestones and maintain documentation to ensure complete understanding among stakeholders and communicate to Program Management.
    • Critically review study design and protocol to identify critical tasks and dependencies, and ensure that study team is prepared and has all required materials and contracts prior to study start
    • Travel domestically on occasion to monitor studies; once every 1-2 months

    Qualifications

     

    Education:

    B.S. in Biology or related field

     

    Experience: 

    • Minimum of 5 years experience in pharmaceutical nonclinical toxicology/safety assessment or research project management.
    • Experience with gene therapy/biologics/small molecule drug development, specifically with a focus on bioanalytical or in vivo pharmacology/toxicology studies.
    • Experience in working in the conduct and monitoring of nonclinical studies.
    • Experience participating on drug development teams.
    • Experience with outsourcing nonclinical studies including CRO selection and management.
    • Understanding of analytical/bioanalytical measurement techniques and methodology.
    • Excellent communication, multitasking, and collaboration skills.
    • Knowledge of FDA GLP regulations is preferred, but not required.

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