Director of Study Operations

Posted 15 Days Ago
Be an Early Applicant
Fort Worth, TX, USA
In-Office
135K-145K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead and oversee clinical research operations for oncology early‑phase trials, managing CRC, data, and medical records teams. Ensure GCP and regulatory compliance, timely data management in Veeva/CTMS/EHR, support study startup/activation, drive process improvements, cross‑department collaboration, training, SOP/QMS adherence, and site operational leadership.
Summary Generated by Built In

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.  


We are seeking a Director of Study Operations will lead research operations, ensuring all aspects of study conduct are performed according to START standards, regulatory standards, and with highest quality patient care. This role provides direction and oversight to the Clinical Research Coordinator, Data Coordinator and Medical Records teams with a high degree of autonomy. 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.

The annual base salary for this remote role is $135,000-145,000 . However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience.


Work Schedule: M-F 8:00AM-5:00PM

Location: START Dallas-Fort Worth, TX


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.
  • Other duties may be assigned at any time.

Required Education and Experience:

  • 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.
  • Other duties may be assigned at any time.

Preferred Education and Experience:

  • Master's degree in health administration, nursing or other related field
  • BLS/ACLS


Best-in-Class Benefits and Perks 

We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally: 


  • 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’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll 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’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.  


Ready to be part of a team changing the future of cancer treatment? 

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. Please submit your application online. 


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. 

Skills Required

  • Leadership of Clinical Research Coordinator, Data Coordination, and Medical Records teams
  • Ensure compliance with GCP and federal/regulatory requirements
  • Experience with Veeva for clinical data management
  • Experience implementing and using CTMS and EHR systems
  • Familiarity with SOPs and Global QMS processes, including SOP review and revision
  • Experience supporting study acquisition, activation, and protocol feasibility review
  • Experience with training, documentation, and staff competency assessment
  • Use of continuous process improvement techniques in clinical operations
  • Master's degree in health administration, nursing, or related field
  • BLS/ACLS certification
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
294 Employees
Year Founded: 2007

What We Do

Deeply rooted in community oncology centers globally, the START Center for Cancer Research ('START') provides patients with access to specialized Phase 1 clinical trials for novel anti-cancer agents. With research sites in the United States and in Spain, Portugal, and Ireland, START’s clinical trial sites have conducted more than 1,500 early phase clinical trials, including for 50 therapies that have gained FDA/EMA approval.

Similar Jobs

Optum Logo Optum

Senior Nurse Manager ASC - Fort Bend Kelsey Seybold Clinics

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
Sugar Land, TX, USA
160000 Employees
92K-164K Annually

Optum Logo Optum

RN - Behavioral Health - Kelsey-Seybold Clinic - Pearland

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
Pearland, TX, USA
160000 Employees
29-52 Hourly

Optum Logo Optum

Supervisor, Healthcare Informatics - Kelsey - Seybold Clinic - Remote

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office or Remote
Pearland, TX, USA
160000 Employees
92K-164K Annually

Optum Logo Optum

Medical Assistant WellMed at Kyle

Artificial Intelligence • Big Data • Healthtech • Information Technology • Machine Learning • Software • Analytics
In-Office
Kyle, TX, USA
160000 Employees
16-29 Hourly

Similar Companies Hiring

Sailor Health Thumbnail
Healthtech • Social Impact • Telehealth
New York City, NY
20 Employees
Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account