Study Activations & Readiness Specialist

What We Do 

Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every patient. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are 

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. 

Position Overview 

The Study Activation & Readiness Specialist will support study, site & staff readiness to ensure FPI is achieved at site level for assigned trials for both the traditional and decentralized site models. They are responsible for ensuring compliance with regulations and supporting start up activities. They are also responsible for ensuring any new staff added to sites have appropriate readiness tasks to work on the study.

What You'll Be Working On (Duties include but not limited to):

• Ensure effective communication on projects to stakeholders
• Support key regulatory requirements for site readiness within the Shared Investigator Platform
• Support essential document management
• Support audits and monitoring visits
• Provide support to study team members and site staff to ensure training technologies related to a Protocol, EDC, EMR and various other systems and technologies relevant to the role.
• Review and understand study information and understand start-up timelines, requirements, key contacts, and performance expectations
• Communicate with site staff, sponsor contacts and vendors to resolve study specific training and access issues
• Perform access reviews to ensure access to resources related to job function. 
• Perform other duties and responsibilities as assigned.
• Participate in department and study meetings
• Support department growth and process optimization 

Physical and Travel Requirements

• This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.

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

• Strong Project Management skills
• Demonstrated Understanding of clinical research infrastructure and assists with operational improvements.
• Hands-on experience with using web technologies and software platforms in clinical research
• Ability to present findings and discuss issues with providers confidently and effectively
• Ability to handle sensitive communications with team leads, internal teams and sponsor representatives
• Ability to address arising issues using creative problem solving skills
• Ability to function independently and in a team environment.
• Ability to multi-task and manage competing priorities and a diverse workload, while achieving results in a fast-paced, deadline-driven environment.
• Ability to problem-solve and generate creative solutions to onboarding challenges, while working effectively with providers, staff and business partners.
• Ability to work with cross-functional teams.
• Excellent Google Sheet skills with proficiency in Google Suite, internet research and database functionality.
• Excellent technology skills and understanding of operating systems and hardware.
• Excellent interpersonal and customer service skills with the ability to interact effectively with clinical professionals and business partners at all levels of the organization.

Certifications/Licenses, Education, and Experience:

• Bachelor's degree in a related field or the equivalent experience 

Benefits (US Full-Time Employees Only)

• PTO/vacation days, sick days, holidays.
• 100% paid medical, dental, and vision Insurance. 75% for dependents.
• HSA plan
• Short-term disability, long-term disability, and life Insurance.
• Culture of growth and equality
• 401k retirement plan

Diversity & Inclusion 

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the 

physicians and caring for patients. 

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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. 

Care Access is unable to sponsor work visas at this time. 

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.