Care Access is looking for a Study Start Up Manager to play a critical role in facilitating the activities needed to select and activate clinical trial sites. You will lead cross-functional groups to complete pre-site visits and accelerate site activation, supporting our mission to expand access to research.

What You'll Do

Collect and interpret information from the Protocol and site feasibility teams to prepare for site evaluation visits.
Oversee the execution of Site Activation strategy, adhering to project timelines.
Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan.
Lead the process of study start-up to support site evaluation and selection visits for new studies.
Support sites through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent.
Collect and review study activation requirements, timelines, key contacts, and performance expectations.
Manage communications and expectations with the client (Sponsor and/or CRO).
Provide overall guidance and oversight of programs during the initial start-up phase.
Manage communications and expectations with site staff.
Support sites through their evaluation and begin start-up activities upon selection.
Work closely with onsite staff to address their remaining questions about the study.
Ensure all information gained during start-up is completely transitioned to sites and other central teams.
Partner with other Care Access teams to initiate study-related processes at the appropriate SSU milestone.
Liaise with internal key stakeholders across the organization to establish timelines and needs.
Drive and support Care Access sites throughout the activation process, ensuring risk assessment and mitigation.
Assist with triggering internal departments such as source, vendor management, and operational compliance.
Manage vendor requirements.
Handle start-up escalation and mitigation.
Track and report on forecasted and actual SSU submission and approval timelines.

What We're Looking For

Minimum 3+ years of clinical research experience.
At least 1 year of relevant experience completing study start-up activities at a site.
Expert knowledge of general clinical research processes and Good Clinical Practice.
Excellent written and verbal communication skills.
High level of professionalism and confidentiality.
Excellent interpersonal skills.
Ability to manage against tight timelines and competing priorities.
Strong judgment and ability to make evidence-based decisions.
Proficient with Microsoft Office Suite.
Ability to work collaboratively across departments.
Excellent project and process management skills; ability to prioritize in a fast-paced environment and pivot based on changing needs.
Ability to build relationships effectively in a geographically dispersed, largely remote environment.
Ability to independently coordinate and manage new processes.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Nice to Have

Bachelor’s degree in life sciences or equivalent.
6-10 years of experience in lieu of degree.

Technical Stack

Microsoft Office Suite

Benefits & Compensation

Compensation: $90,000 - $100,000 USD per year for full-time team members.
Paid Time Off (PTO) and Company Paid Holidays.
100% Employer paid medical, dental, and vision insurance plan options.
Health Savings Account and Flexible Spending Accounts.
Bi-weekly HSA employer contribution.
Company paid Short-Term Disability and Long-Term Disability.
401(k) Retirement Plan, with Company Match.

Work Mode

This is a fully remote position open to candidates in the United States.

Care Access is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.