Job Description

Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection.

The Department of Surgery Clinical Research Core supports a large and diverse portfolio of more than 80 active clinical research studies across multiple surgical divisions, including Vascular Surgery, Cardiac Surgery & Lung Transplantation, Thoracic Surgery, Surgical Oncology, General Surgery, and Endocrine Surgery. The Clinical Research Supervisor II serves as an operational leader within the Clinical Research Core and is responsible for managing an assigned portfolio of clinical research studies, investigators, and Clinical Research Coordinators (CRCs). This position provides full operational oversight throughout the study lifecycle, including feasibility assessment, study startup, regulatory implementation, financial oversight, enrollment management, quality assurance, study conduct, and closeout, while also overseeing staffing, performance management, programmatic workflow, and financial stewardship for assigned studies. The supervisor serves as the primary operational contact for assigned investigators and sponsors and is accountable for ensuring studies are conducted efficiently, compliantly, and in accordance with departmental objectives. Collaborates with fellow Clinical Research Supervisors and Clinical Research Core leadership to develop operational strategies supporting the Clinical Research Core, including staffing models, study portfolio management, workload forecasting, study startup planning, resource allocation, program development, and continuous process improvement. Exercises independent judgment in managing assigned portfolios while collaborating with leadership on complex operational, financial, or programmatic initiatives.

Responsibilities

of time

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

30%

Yes

Supervises staff work assignments and schedules to meet clinical research goals and timelines. Meets regularly with assigned staff to set goals and ensure objectives are being met. Directly supervises subordinates' quality and quantity of work to ensure studies meet objectives and are compliant with all regulations. Advises employees regarding resolution of technical problems. Communicates and collaborates with cross-functional teams.

Manage routine portfolio meetings with assigned Clinical Research Coordinators to review study progress, identify operational risks, establish priorities, assign follow-up actions, and ensure accountability for study milestones.

20%

Yes

Direct responsibility for delivery of key trial goals and objectives, including enrollment targets and outcome event adjudication. Monitors compliance with all policies and processes. Adheres to standards.

Maintains operational awareness of assigned studies and proactively identifies issues requiring intervention to support successful study execution.

Provides operational leadership for an assigned portfolio of clinical research studies and oversees studies from feasibility assessment and startup through study conduct and closeout.

Oversees all phases of assigned studies, including feasibility assessment, regulatory approvals, study startup, protocol implementation, budget development, contract coordination, invoice management, research billing oversight, revenue tracking, enrollment oversight, data management, monitoring activities, and final sponsor closeout requirements.

Reviews and resolves research billing discrepancies, ensures appropriate billable trigger identification, collaborates with the post-award finance team to support financial stewardship of assigned studies, and prepares, reviews, and approves study-related operational and regulatory documents to ensure compliance with sponsor, institutional, and regulatory requirements.

Serves as the primary operational lead for assigned investigators, sponsors, and Clinical Research Coordinators throughout the study lifecycle.

5%

Yes

Serves as the main liaison between clinical trials and program leaders. Proposes solutions to difficulties arising from multidisciplinary research, implements structural changes to maximize time efficiency within the constraints of limited resources.

Develops operational recommendations and collaborates with Clinical Research Supervisors and Clinical Research Core leadership to implement process improvements, improve workflows, and maximize operational efficiency.

5%

Yes

Administers fiscal, material and human resources within study budget. Plans and implements resource allocations to individual trials.

Participates in long-range operational planning for the Clinical Research Core, including staffing models, workload forecasting, study portfolio planning, and resource allocation to support efficient and sustainable research operations.

Suggests ways to be more efficient. If necessary, requests additional resources. Manages revenue collection, invoicing, and reimbursement accounting.

Interfaces with clinical monitors to review data accuracy, protocol violations and deviations, and regular updates to reporting.

5%

Yes

Reviews new budget proposals for feasibility with industry sponsors, creates internal budgets for grants, creates invoices, and reconciles budget spending and salary support. Reviews and monitors all research related charges to ensure budgetary compliance.

Oversees financial planning for assigned studies from startup through closeout and evaluates financial implications of operational decisions affecting assigned portfolios.

5%

Yes

Oversees clinical research data management activities supporting assigned study portfolios. Compiles study reports as needed and provides investigators, research staff, and trainees with guidance regarding study design, data collection, and data management. Serves as a resource for study logistics and clinical research operations.
20%

Yes

Recommends salary actions, promotions, and terminations. Conducts necessary personnel actions for assigned staff including disciplinary actions. Recommends changes in staffing and changes to budget to ensure the efficient operation of the function. Participates in recruitment and orientation of new employees.

Training & Onboarding:Develop and implement comprehensive onboarding programs and ongoing training plans for Clinical Research Coordinators and other Clinical Research Core personnel.

Train coordinators on study startup activities, clinical research operations, regulatory processes, REDCap and CTMS platforms, research billing, adverse event reporting, and protocol compliance. Continuously assess training needs, mentor CRC staff, and collaborate with fellow Clinical Research Supervisors and Clinical Research Core leadership to develop standardized training materials, onboarding processes, operational workflows, and Clinical Research Core standards that promote consistency and operational excellence across multiple surgical divisions.

Evaluates assigned staff performance and competency. Defines individual development goals. Mentors professional staff, including employees that are learning a new area of clinical practice. Encourages assigned staff to further their knowledge through clinical education, and certifications.

Provides mentorship to develop independent operational leadership, critical thinking, and decision-making skills among assigned Clinical Research Coordinators.

10%

Yes

Leads and contributes to Clinical Research Core operational initiatives by developing standardized workflows, onboarding processes, quality improvement activities, SOPs, training resources, and cross-divisional best practices.

Collaborates with fellow Clinical Research Supervisors and Clinical Research Core leadership to support program development, operational consistency, scalability, and continuous process improvement across multiple surgical divisions.

100%
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Qualifications

Required Qualfications

• Bachelor's degree in related area.
• Minimum of 3 years of Lead/Supervisory/Manager experience.
• Minimum of 5 years of relevant experience.
• Broad knowledge of clinical or laboratory research and clinical research philosophy. Demonstrated ability to translate clinical research philosophy into business best practices in a trial setting.
• Demonstrated project management skills. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated experience managing people with a wide range of educational backgrounds and skills. Demonstrated management and conflict resolution skills to effectively lead and motivate others. Demonstrated experience in training others in the field of research.
• Demonstrates good problem-solving and analytical skills. Creatively addresses complex or new problems.
• Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.
• Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended study team. Ability to influence / persuade. Proven ability to effectively coordinate and integrate programs with others in division, department, and organization.
• Comprehensive knowledge of clinical research operations including clinical trial coordination, regulatory compliance (FDA, ICH-GCP, IRB), adverse event and protocol violation reporting, and quality data submission across diverse study types (IND, device, investigator-initiated, and federal).
• Demonstrated experience supervising and managing clinical research staff, including hiring, onboarding, training, performance evaluation, and workload management across a multi-study, multi-division research portfolio.
• Experience with study startup activities: feasibility review, IRB submissions (initial, amendments, modifications, SAEs), coverage analysis, budget development, and clinical trial contract execution.
• Knowledge of research billing compliance, including billing trigger identification, invoice tracking, charge dispute resolution, and coordination with post-award finance teams.
• Proficiency with REDCap, clinical trial management systems (CTMS), and EHR-based research platforms; ability to generate reports and conduct quality assurance reviews of data entry and regulatory documentation.
• Demonstrated ability to develop, implement, and maintain standardized SOPs, training programs, and quality improvement processes across a large, complex research program.

Certifications

• Clinical Trial Professional certification from a professional society within one year in position; CCRP certification (through SOCRA).

Preferred Qualifications

• Advanced degree.