About the Role
Title: Study Activations & Readiness Specialist
Location: Remote, US
Type: Full Time – Regular
Workplace: remote
Category: Trial Management
Job Description:
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