Clinical Research Operations Manager - Full time - Days

Mohawk Valley Health System•City of Utica, NY

2d•Onsite

About The Position

The Clinical Research Operations Manager (CROM) provides strategic oversight and administrative leadership for all department activities within the Clinical Trials Office (CTO). Operating at the intersection of the Quality and Research teams, this role is responsible for aiding in the development, implementation, and long-term sustainability of a system-wide Program of Clinical Research. The CROM serves as the primary point of contact for the CTO, liaising with executive leaders, clinical investigators, and industry sponsors to streamline the clinical trials processes for MVHS. The CROM will ensure protocol integrity, and foster a culture of quality, compliance, and research excellence across the healthcare system.

Requirements

Bachelor’s degree in Life Sciences, Nursing, Healthcare Administration, or a related field.
8 years of experience in facilitating clinical research within a healthcare system or academic medical setting.
Comprehensive understanding of FDA regulations, ICH-GCP guidelines, and IRB requirements.
Exceptional leadership and interdisciplinary collaboration skills.
Proven ability to develop and implement complex organizational workflows.
Strong verbal and written communication skills for executive-level reporting and staff training.

Nice To Haves

Master’s degree, or dual degrees in Life Sciences, Nursing, Healthcare Administration, or a related field.
2–3 years in a supervisory or management role.
Regulatory training certificates from an accredited entity with coursework covering Human Subjects Research (HSP) and Good Clinical Practice (GCP) is required.
Professional certification (e.g., CCRP via SoCRA or CCRC via ACRP).

Responsibilities

Provide Operational Leadership: Direct day-to-day operations of the CTO, providing guidance and administrative support to developing research teams.
Develop Policies and Processes: Author and implement departmental policies, Standard Operating Procedures (SOPs), and regulatory templates to standardize research activities across all clinical service lines.
Regulatory Compliance Oversight: Ensure all research activities maintain protocol integrity and strictly align with federal/international regulations and the Principles of Good Clinical Practice (GCP).
Key Stakeholder Management: Act as the primary point of contact for investigator-initiated, federally funded, and industry-sponsored research studies.
Program Development & Education: Lead the recruitment and training of designated research teams. Provide ongoing education to clinical staff to embed compliant research practices into the organizational culture.
Strategic Organizational Growth: Collaborate with executive leaders to expand the research program’s footprint and identify new opportunities for clinical innovation.
Human Resources: Drive performance by recruiting, training, and mentoring staff, setting clear goals, providing actionable feedback, performance improvement plans and fostering a positive, compliant work environment to achieve organizational objectives.