What We Do
Care Access is a distinctive, multi-specialty network of research sites that functions as a unified team of physician investigators, nurse coordinators, and operations managers.

Who We Are
We are driven by care. Our team powers our mission to transform access to clinical trials for patients worldwide. We support each other, foster innovation to advance medicine, and strive to make a lasting impact for future generations.

Position Overview
Study Start-Up Managers at Care Access play a vital role in coordinating the necessary steps to select and activate clinical studies at our sites. They lead cross-functional teams across our global organization to ensure successful pre-site visits and expedite study activation, following established processes, industry regulations, Care Access SOPs, and study-specific guidelines.

Key Responsibilities (including but not limited to):

– Analyze information from protocols, business development strategies, and site feasibility teams to prepare site staff for evaluation visits.
– Manage the site activation process and strategy, ensuring alignment with project timelines and developing a Management Plan based on the Scope of Work and Project Plan.
– Lead study start-up efforts to support site evaluation and selection, ensuring selected sites are activated and ready to enroll participants.
– Guide sites through evaluation and initiation visits, and the greenlight process.
– Gather and review study activation requirements, understand timelines, key contacts, and performance expectations.
– Serve as the main point of contact for communication with sponsors and CROs.
– Provide oversight and direction during the initial start-up phase as a key member of the study start-up team.
– Maintain clear communication with site staff and support them through evaluation and activation.
– Collaborate with site teams to resolve study-related questions.
– Ensure all start-up information is effectively transferred to sites and central teams.
– Coordinate with other Care Access teams to initiate study-related processes at appropriate milestones (e.g., capacity planning, system setup).
– Work with internal and global stakeholders to define timelines and requirements.
– Support Care Access sites through the activation process, including risk assessment and mitigation.
– Coordinate with internal departments such as sourcing, vendor management, and compliance.
– Manage vendor-related requirements.
– Handle start-up issue escalation and resolution.
– Monitor and report on forecasted and actual start-up submission and approval timelines.

Scope of Role:

– Autonomy: Performs duties with general supervision.
– Direct Reports: None.

Physical Requirements:

– This is a fully remote role requiring the use of computers and related equipment.

Travel Requirements:

– This remote position requires less than 10% travel, with occasional planned trips.

What You Bring (Knowledge, Skills, and Abilities):

– In-depth understanding of clinical research processes and Good Clinical Practice (GCP).
– Strong written and verbal communication skills.
– High professionalism and discretion.
– Excellent interpersonal abilities.
– Capability to manage tight deadlines and multiple priorities.
– Sound judgment and evidence-based decision-making.
– Proficiency in Microsoft Office Suite.
– Collaborative mindset across departments.
– Strong project and process management skills; adaptable to fast-paced environments.
– Ability to build relationships in a mostly remote, geographically dispersed team.
– Self-starter with the ability to manage new processes independently.
– Strong relationship-building skills with colleagues, managers, and clients.

Certifications/Licenses, Education, and Experience:

– At least 3 years of clinical research experience, including 1 year in study start-up at a site.
– Bachelor’s degree in life sciences preferred (or 6–10 years of relevant experience in lieu of a degree).

Benefits:

– Paid time off, sick leave, and holidays.
– Fully covered medical, dental, and vision insurance; 75% coverage for dependents.
– Health Savings Account (HSA) plan.
– Short-term and long-term disability insurance, and life insurance.
– Inclusive and growth-oriented culture.
– 401(k) retirement plan.

Diversity & Inclusion
We work with patients and researchers from diverse backgrounds and are committed to building a team that reflects the communities we serve. We foster an inclusive environment where everyone feels respected and valued. Diversity strengthens our mission and drives innovation. At Care Access, we are advancing medical breakthroughs by integrating standard care with cutting-edge research. We bring transformative treatments to patients and collaborate with top physicians and industry leaders.

We are an equal opportunity employer. All qualified applicants will be considered regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability, genetic information, veteran status, or any other legally protected status.

Note: Care Access does not currently sponsor work visas.

Employment Statement
Care Access adheres to all employment laws and regulations, ensuring fair practices, equitable pay, and compliance with labor standards. We do not tolerate forced labor, child labor, or human trafficking in any form, including within our supply chain and partnerships. We are committed to upholding human rights globally.