Director of Study Operations

The START Center for Cancer Research; Pittsburgh (Allegheny County); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) with match

Annual bonus

Paid time off

Medical/dental/vision

Life and disability insurance

EAP

FSA/HSA

Inclusive culture

Job summary

The START Center for Cancer Research in Pittsburgh is seeking a Senior Leader to guide Clinical Research Coordinators, Data Coordination and Medical Records teams in delivering high-quality patient care within oncology trials.

You will train staff, ensure GCP compliance, and manage data across CTMS, EHR, and related systems while collaborating with global partners to accelerate study initiation and ensure regulatory standards are met.

Qualifications

• Bachelor’s degree required in a relevant field.
• 5+ years of leadership experience in oncology clinical research.
• CITI GCP training completed.
• Knowledge of GCP, GDPR and US clinical research regulations.

Responsibilities

• Provide leadership to Clinical Research Coordinator, Data Coordination and Medical Records teams.
• Train staff and demonstrate competency for roles.
• Ensure timely data management and regulatory compliance (GCP, SOPs).
• Support study acquisition and activation with global teams.
• Improve processes to support patient care workflows in research settings.
• Review incoming protocols for feasibility with operations teams.
• Coordinate with regulatory, quality, site development, pharmacy and finance.
• Support CTMS, EHR and other systems for accurate documentation.
• Collaborate with department leaders to drive site operations improvements.
• Serve as change agent for strategic projects locally and regionally.

Skills

Leadership

Team training

Interdepartmental collaboration

Quality-focused

Education

Bachelor’s degree

Master's degree (preferred)

Tools

Microsoft Office

Clinical documentation systems

Job description

Essential 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.

Required Education And Experience

• 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.

Preferred Education And Experience

• Master\'s degree in health administration, nursing or other related field


• BLS/ACLS

Physical And Travel Requirements

• Approximately 80% of time is spent sitting.


• Very fast-paced and ever-changing healthcare environment.


• Demanding deadlines and time frames.


• Constant demand for updating knowledge.


• Works closely with physicians and ancillary personnel in caring for and treating oncology/hematology patients.


• Intermittent travel, less than quarterly, to support new site activation

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


• We\u2019re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you\u2019ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.

More About START

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\u2019s 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 atSTARTresearch.com.

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.