Pre-Screening Coordinator

Pre-Screening Coordinator

Remote, US

Full time – Temporary

Remote

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 Pre-Screening Lab Process Coordinator will serve as an integral part of the organization by helping to facilitate oversight of lab result process for Care Access’s Pre-Screening Program. This role will ensure that labs have resulted, reported, filed, and escalated with appropriate medical oversight.

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

Lab Management:

· Coordinate with clinical and administrative staff, and management to ensure that all necessary labs are returned to the proper party.

· Ensure that all lab results are accurately recorded, filed in the appropriate participant’s medical record, and communicated with the Retention Team.

· Escalate abnormal lab results to the appropriate medical personnel and ensure proper medical oversight is maintained.

· Communicate with Care Access and vendor laboratories to ensure samples have properly resulted.

· Perform checks of participant data in tech systems to ensure accurate lab reporting.

· Effectively perform quality checks of teammates’ work to ensure the highest level of data quality.

· Maintain a call schedule with lab process manager for communicating needs such as medical oversight and cross functional collaboration.

· Perform duties of the role in compliance with state specific guidelines, legal, regulatory, and organizational policies.

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):

    • Successfully able to manage multiple sites/projects.
    • Strong organizational skills: Able to prioritize, support, and follow through on assignments.
    • Thorough knowledge of company SOPs and Care Access Project Specific process flows/ expectations
    • Good working knowledge of federal regulations, good clinical practices (GCP) especially as it relates to research laboratory processes.
    • Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors.
    • Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring a positive and supportive attitude to achieving these goals.
    • Strong computer skills with demonstrated abilities using clinical trials databases and Microsoft systems.
    • Maintain a positive attitude under pressure.
    • High level of self-motivation and energy
    • Must have a client-service mentality.

Certifications/Licenses, Education, and Experience:

    • Fluent reading and writing in Portuguese
    • Will be required to work in Brazil operating hours.
    • 1 year of Clinical Research experience, clinical research laboratory experience is a plus.
    • Strong knowledge of GCP-ICH requirements and data collection in a research setting
    • Proficient in research terminology and medical (basic) terminology
    • Strength in communication, planning, and time management skills
    • Strong People Skills
    • Office/business skills and computer skills

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