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About the Role

This role will lead research operations, ensuring all aspects of study conduct are performed according to START standards, regulatory standards, and with highest quality patient care. The Director, Study Operations collaborates closely with the Director, Nursing and Shared Services teams to support overall clinic operations, Study Acquisition / Activation and Quality Assurance activities. In addition, this role will provide direction for department processes, training, employee recruitment, retention, and supervision for their areas of responsibility.

Responsibilities

Provide effective, proactive leadership to Clinical Research Coordinator team, Data Coordination team and Medical Records to ensure quality care delivery and ability to meet site specific key performance indicators.
Provide effective training and demonstrate competency of staff and management team for respective job roles.
Ensure timely and effective data management and communication with monitors and auditors, full compliance with GCP, and training documentation for all data management staff.
Uphold all SOPs, including their review and revision as described in the Global QMS program.
Support study acquisition and activation functions in collaboration with global shared services team to meet START goals for speedy study start up and network-wide study acquisition functions, including facilitating protocol review meetings and overseeing accurate data collection and documentation in Veeva and any other required systems.
Ensure departments are using efficient, effective processes and systems to support patient care workflows and compliant care delivery in the context of clinical research protocols.
Use continuous process improvement techniques to proactively identify and address areas of improvement for the good of the patients, team members and the organization as a whole.
Review all incoming protocols for feasibility with respect to clinical research operations, specifically research coordinator teams.
Ensure effective inter-departmental interaction and communication with other support departments including regulatory, quality, site development, pharmacy and finance to ensure successful care delivery and compliance with all federal, GCP and regulatory agency requirements.
Support effective use and implementation of CTMS system, EHR system, and other necessary software to ensure appropriate and accurate documentation and data capture in the departments of responsibility.
Collaborate with other department leaders to proactively identify and address areas for process improvement.
Collaborate with Director, Nursing to lead site operations and act as a change agent for strategic project efforts both at the local level and regionally.

Requirements

Bachelor’s degree
5 years of leadership experience in an oncology clinical research setting.
CITI GCP training.
Knowledge of GCP, GDPR and federal clinical research regulations required in US.
Must be familiar with Microsoft Office applications and clinical documentation systems.

Location

Albany, New York

Work Type

Monday-Friday 8:00am-5:00pm

Experience Level

5 years of leadership experience

Education Level

Bachelor’s degree
Master’s degree in health administration, nursing or other related field

Salary/Compensations

$135,000 - $145,000

Benefits

401(k) retirement savings plan with employer match
Eligibility for an annual performance bonus, based on role and company results
Generous paid time off and paid holidays
Comprehensive medical, dental, and vision coverage and optional insurance options
Company paid life and disability insurance for added financial protection
Employee Assistance Program (EAP) providing confidential, no‑cost support for you and your family from day one
Flexible FSA and HSA plans to support your financial wellness
Commitment to a supportive environment that values balance, wellbeing, and flexibility

About the Company

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research.
Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe.
START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA.
START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites.
Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”.
Learn more at STARTresearch.com.
Join us in our mission to conquer cancer, one clinical trial at a time.
Your expertise and dedication can help us bring hope and healing to patients worldwide.

Equal Opportunity

We are an equal opportunity employer that welcomes and encourages diversity in the workplace.
We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.