Operations Business Lead - Clinical Research

Job Description

The Operations Business Lead – Clinical Research supports the Director of Growth & Partnerships in the coordination and execution of clinical research growth initiatives, new partnerships, study opportunities, and operational priorities.

This role is responsible for helping ensure that work moves forward across clinical research operations,
investigators, finance, legal, regulatory, sponsors, CROs, and other internal and external stakeholders.
Rather than directly leading clinical research programs or owning individual functional areas, the
Operations Business Lead provides coordination, follow-through, visibility, and accountability across
initiatives.

The ideal candidate understands clinical research operations and business processes well enough to
recognize what needs to happen, who needs to be involved, where barriers exist, and when issues need to be escalated.

Operational Coordination & Execution: 

• Support the Director of Growth & Partnerships in executing clinical research growth and operational initiatives.

• Coordinate activities associated with new research sites, provider partnerships, and study opportunities.

• Develop and maintain project plans, timelines, action items, and deliverables.

• Ensure responsible stakeholders understand expectations, deadlines, and dependencies.

• Follow up across functional teams to ensure agreed-upon activities are completed on time.

• Identify delays, operational gaps, and unresolved issues and escalate them to the appropriate leader.

• Facilitate communication between departments when activities require cross-functional coordination.

• Maintain visibility into the status of key initiatives and provide regular updates to the Director of Growth & Partnerships.

• Assist with developing standardized processes, tools, templates, and workflows that improve consistency and efficiency.

Study Feasibility & Startup Support:

• Assist with the coordination of study feasibility assessments and new study opportunities.

• Gather information from investigators, clinical teams, operations, and other stakeholders necessary to evaluate potential studies.

• Track feasibility requests, responses, deadlines, and outstanding information.

• Help assess operational considerations including staffing, patient population, equipment, space, technology, and investigator availability.

• Coordinate follow-up activities after study selection to help ensure startup requirements progress according to established timelines.

• Track startup barriers and escalate issues that may affect study activation.

Financial & Contract Coordination:

• Assist with the operational review of clinical trial budgets and Clinical Trial Agreements (CTAs).

• Coordinate information needed from operations, finance, legal, investigators, and other stakeholders during budget and contract review.

• Support development and review of study financial models and P&Ls.

• Help identify operational costs, staffing requirements, procedures, and other expenses that should be considered during budget development.

• Track outstanding contract and budget items and facilitate follow-up with responsible parties.

• Monitor timelines and escalate delays that could affect study startup or sponsor relationships.

• Assist with tracking study financial performance and identifying significant variances requiring additional review.

Recruitment & Enrollment Support:

• Assist with development and coordination of study-specific patient recruitment strategies.

• Work with research and clinical teams to identify available patient populations and potential recruitment channels.

• Help coordinate recruitment activities across practices, investigators, research teams, and approved external resources.

• Track recruitment and enrollment performance against established goals.

• Identify studies that are falling behind enrollment expectations and facilitate discussions regarding potential solutions.

• Support implementation of recruitment initiatives developed by clinical research leadership and operational teams.

Investigator & Provider Support:

• Serve as a resource and point of coordination for investigators and provider practices participating in clinical research.

• Assist with onboarding new investigators and practices into the research program.

• Coordinate meetings, training, operational discussions, and required follow-up activities.

• Help ensure investigator questions and operational concerns are routed to the appropriate team and resolved in a timely manner.

• Track outstanding provider needs and commitments.

• Support communication between investigators and internal research teams.

• Recognize when providers or practices may require additional operational support and communicate those needs to leadership.

Sponsor & CRO Coordination:

• Assist the Director of Growth & Partnerships with sponsor and CRO relationships and communications.

• Coordinate information requested regarding investigators, site capabilities, patient populations, feasibility, and operational readiness.

• Track sponsor and CRO requests and ensure appropriate internal stakeholders provide necessary information.

• Assist with preparation of site capability materials, presentations, and partnership discussions.

• Help ensure commitments made to sponsors and CROs are communicated internally and appropriately followed through.

Cross-Functional Coordination & Accountability:

• Serve as a central point of coordination for initiatives involving multiple departments.

• Maintain action-item trackers and clearly document owners, deadlines, dependencies, and status.

• Follow up with responsible stakeholders on outstanding deliverables.

• Facilitate meetings when cross-functional alignment is needed.

• Document decisions, next steps, and responsibilities following key meetings.

• Identify issues that may impact timelines, financial performance, study activation, enrollment, or partner relationships.

• Escalate unresolved issues to the Director of Growth & Partnerships or appropriate functional leader.

• Help create greater consistency and predictability across clinical research business and operational processes.

Key Performance Indicators:

• Timely completion of assigned action items and deliverables

• Reduction in outstanding or overdue operational items

• Study feasibility turnaround time

• Study startup and activation timeline performance

• CTA and budget coordination timelines

• Timeliness of cross-functional follow-up

• Recruitment and enrollment tracking

• Investigator and provider responsiveness

• Resolution and escalation of operational barriers

• Accuracy and visibility of project and initiative status

• Sponsor and CRO request turnaround

• Effectiveness of communication across functional teams

Qualifications

• Bachelor’s degree in healthcare administration, business, life sciences, clinical research, nursing, or related field; equivalent relevant experience may be considered.

• 5–7+ years of experience in clinical research, healthcare operations, project coordination, research site operations, or a related field.

• Working knowledge of clinical trial operations and study startup processes.

• Understanding of study feasibility, clinical trial budgets, and CTAs.

• Ability to understand basic study financials, including revenue, direct costs, overhead, and study-level P&Ls.

• Strong project management and organizational skills.

• Demonstrated ability to coordinate activities across multiple departments and stakeholders.

• Strong attention to detail and ability to manage multiple priorities and deadlines.

• Excellent written and verbal communication skills.

• Ability to identify barriers and appropriately escalate issues without assuming ownership of another functional area's responsibilities.

• Experience supporting new clinical research sites or research program expansion.

• Experience working with investigators, physician practices, sponsors, and CROs.

• Experience with CTMS, eRegulatory, EDC, or related clinical research systems.

• Familiarity with patient recruitment and enrollment strategies.

• Knowledge of ICH-GCP, FDA regulations, and clinical research requirements.

The salary range for this role is $90,000.00 to $110,000.00 in base pay and exclusive of any bonuses or benefits (medical, dental, vision, life, and pet insurance, 401K, paid time off, and other wellness programs). This role is also eligible for an annual bonus targeted at 15% and restricted stock units .The base pay offered will be determined based on relevant factors such as experience, education, and geographic location

Additional Information

All your information will be kept confidential according to EEO guidelines.

Technical Requirements (for remote workers only, not applicable for onsite/in office work):

In order to successfully work remotely, supporting our patients and providers, we require a minimum of 5 MBPS for Download Speed and 3 MBPS for the Upload Speed. This should be acquired prior to the start of your employment. The best measure of your internet speed is to use online speed tests like https://www.speedtest.net/. This gives you an update as to how fast data transfer is with your internet connection and if it meets the minimum speed requirements. Work with your internet provider if you have questions about your connection. Employees who regularly work from home offices are eligible for expense reimbursement to offset this cost.

Privia Health is committed to creating and fostering a work environment that allows and encourages you to bring your whole self to work. We understand that healthcare is local and we are better when our people are a reflection of the communities that we serve. Our goal is to encourage people to pursue all opportunities regardless of their age, color, national origin, physical or mental (dis)ability, race, religion, gender, sex, gender identity and/or expression, marital status, veteran status, or any other characteristic protected by federal, state or local law.