Position Summary
Clinical Research Program Managers play a critical role within the Caris Operations business unit. Tasked with a diverse range of responsibilities supporting both internal and external customers as it relates to conducting clinical research, trial enrollment services and systems integrations with Caris. This role is hyper focused on downstream coordination and pull-through activities ensuring business requirements are met, responded to appropriately and delivering on time results. This role acts as a liaison between/across multiple departments within Caris, between Caris and the Precision Oncology Alliance (POA), and other business partners. The incumbent operates in a supportive function within the fast-paced multifaceted business unit supporting an array of business owners, relationships and initiatives.

Job Responsibilities

• Leads support activities related to conducting clinical research studies, clinical trial enrollment and POA research initiatives.
• Ensures POA coverage teams are equipped with the necessary information to respond timely to site requests or address specific topics that fall within the purview of Caris Clinical Research Operations.
• Conduct site facing presentations introducing study opportunities, data sharing and honest broker procedures/workflows, regulatory requirements, clinical trial matching and enrollment services, and system integrations (research and testing).
• Development and deployment of a strategy to meet or exceed company’s recruitment targets for investigative sites that will participate in Caris-sponsored research studies.
• Responsible for project plans to onboard study sites who participate in Caris sponsored studies.
• Responsible for navigating institutional policies and procedures within each site to create mutually agreed upon plan to execute a given project or initiative. Drives associated contracting processes, regulatory review and system access procedures/requirements.
• Responsible for overall project plans, project management and successful implementation of study/initiative at assigned study sites.
• Maintains proper visibility on all projects for which assigned sites are participating; proactively communicates status across all internal and external stakeholders.
• Actively participates in contract review process and ensures regulatory documentation requirements are met.
• Applies effective project management principles to ensure all projects, initiatives, and contract deliverables are well documented, tracked and reportable.
• Responsible for routine internal status reporting; communicating overall project, engagement status, issues, risk mitigation, and success factors.
• Able to effectively manage multiple assignments/projects at simultaneously in a fast-paced and fluid environment.
• Accepts other duties as assigned.

Required Qualifications

• Bachelor’s degree in a related field.
• 3+ years’ experience in a clinical research setting.
• Experience in project management.
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.

Preferred Qualifications

• Master’s degree in related field.
• 5+ years’ experience in a clinical research setting.
• 2+ years relationship management experience.
• Strong business aptitude, customer focused mindset
• Ability to work independently, self-starter, critical thinker and able to make decision.
• Ability to effectively prioritize and manage multiple projects simultaneously; works well under pressure and able to meet tight deadlines.
• Function in a fast-paced environment by adapting to changes while meeting critical deadlines.
• Detail oriented and highly organized.
• Strong communicator, both written and verbal
• Projects a professional disposition, excellent work ethic and positive attitude.
• Teamwork - Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.

Physical Demands

• Will work at a computer a majority of the time as well as need to keep inventory and ordering records requiring the use of copiers, fax machines, and PDF scanners.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• Occasional business travel is required.
• Travel and work schedule may be required after hours. Responsibilities may include client meetings/dinners after normal business hours. Weekend/evening/holiday work may be required depending on business need, however, is not to be the norm.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability

• Leads support activities related to conducting clinical research studies, clinical trial enrollment and POA research initiatives.
• Ensures POA coverage teams are equipped with the necessary information to respond timely to site requests or address specific topics that fall within the purview of Caris Clinical Research Operations.
• Conduct site facing presentations introducing study opportunities, data sharing and honest broker procedures/workflows, regulatory requirements, clinical trial matching and enrollment services, and system integrations (research and testing).
• Development and deployment of a strategy to meet or exceed company’s recruitment targets for investigative sites that will participate in Caris-sponsored research studies.
• Responsible for project plans to onboard study sites who participate in Caris sponsored studies.
• Responsible for navigating institutional policies and procedures within each site to create mutually agreed upon plan to execute a given project or initiative. Drives associated contracting processes, regulatory review and system access procedures/requirements.
• Responsible for overall project plans, project management and successful implementation of study/initiative at assigned study sites.
• Maintains proper visibility on all projects for which assigned sites are participating; proactively communicates status across all internal and external stakeholders.
• Actively participates in contract review process and ensures regulatory documentation requirements are met.
• Applies effective project management principles to ensure all projects, initiatives, and contract deliverables are well documented, tracked and reportable.
• Responsible for routine internal status reporting; communicating overall project, engagement status, issues, risk mitigation, and success factors.
• Able to effectively manage multiple assignments/projects at simultaneously in a fast-paced and fluid environment.
• Accepts other duties as assigned