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  • Director of Clinical Trials, Medicine
    Medicine
    University at Buffalo



    Director of Clinical Trials, Medicine



    Position Information

    Position Title: Director of Clinical Trials, Medicine
    Department: Medicine
    Posting Link: https://www.ubjobs.buffalo.edu/postings/59463
    Job Type: Full-Time

    Posting Detail Information

    Position Summary


    The University at Buffalo Department of Medicine seeks a highly motivated and experienced Director of Clinical Trials to lead and expand its clinical research infrastructure. This leadership role will oversee all aspects of clinical trial operations within the Department, including regulatory compliance, trial development, coordination, budgeting, and stakeholder engagement. The Director will work closely with faculty investigators, research coordinators, hospital affiliates, sponsors, and institutional offices to support investigator-initiated and industry-sponsored trials.

    Key Responsibilities:

    Leadership & Oversight:


    • Direct and supervise the clinical trials operations team, including research coordinators and regulatory staff.

    • Develop and implement strategic plans for clinical trials growth across divisions.

    • Ensure trials are conducted in accordance with GCP, ICH, FDA, and IRB standards.


    Operational Management:


    • Manage study start-up activities including feasibility, protocol review, contract review, and budgeting.

    • Develop and optimize workflows, SOPs, and quality assurance measures.

    • Coordinate with clinical partners (e.g., UBMD Physicians Group, Kaleida Health, VA Western NY Healthcare System).


    Compliance & Reporting:


    • Serve as primary liaison for regulatory bodies and sponsor audits.

    • Ensure timely submission of IRB protocols, continuing reviews, and adverse event reports.

    • Oversee data integrity and compliance tracking systems.


    Financial & Administrative Management:


    • Collaborate with finance teams to prepare and manage trial budgets, billing compliance, and sponsor invoicing.

    • Monitor and report on enrollment metrics, timelines, and revenue targets.

    • Provide guidance on grant applications and funding opportunities related to clinical research.


    Education & Training:


    • Mentor research staff and faculty on clinical trial best practices.

    • Conduct training on compliance, data management, and protocol implementation.



    Learn more:


    As an Equal Opportunity / Affirmative Action employer, the Research Foundation will not discriminate in its employment practices due to an applicants race, color, religion, sex, sexual orientation, gender identity, national origin and veteran or disability status.


    Minimum Qualifications



    • Bachelors degree with 5 years of experience.

    • Experience in clinical research, including at least 3 years in a leadership or management role.

    • In-depth knowledge of FDA regulations, GCP, and clinical trial operations.

    • Experience working within academic medical centers or large health systems.



    Preferred Qualifications



    • Masters degree in Clinical Research, Public Health, Healthcare Administration, Life Sciences, or related field.

    • Familiarity with Epic, REDCap, OnCore, or similar CTMS platforms.

    • Experience collaborating with investigators in Internal Medicine or related subspecialties.

    • Knowledge of university or state research administration systems.


     


    Physical Demands


    Salary Range
    $110,000 - $120,000

    Special Instructions Summary


    Is a background check required for this posting?
    No

    Contact Information

    Contact's Name: Ariel Burden
    Contact's Pronouns:
    Contact's Title: Staff Assistant
    Contact's Email: aeburden@buffalo.edu
    Contact's Phone: 716-859-4848

    Posting Dates

    Posted: 10/14/2025
    Deadline for Applicants: 10/29/2025
    Date to be filled:




 


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