Care Access
Healthcare
ClinicalResearchCoordinatorII
“Clinical Research Coordinator II at Care Access. Skills: Clinical research, Patient monitoring, Protocol compliance. Screen study subjects. Enroll study subjects”
Industry & Context.
Problem solver; Critical thinker
Regional commute requirements, Up to 10% travel, Regional travel, Use keyboards, Use computer equipment, Walking, Standing, Sitting, Lifting up to 25lbs, Lifting overhead, Driving
What They're Looking For.
Must Have
3 years prior Clinical Research Coordinator experience, Recent phlebotomy experience
Nice to Have
Bachelor’s Degree preferred, 1 year of experience as a Care Access Research Clinical Research Coordinator
What You'll Do.
Screen study subjects
Enroll study subjects
Monitor clinical research study subjects
Ensure protocol compliance
Ensure regulatory compliance
Coordinate patient activities
Maintain adherence to FDA regulations
Maintain adherence to ICH guidelines
Maintain relationships with study participants
Maintain relationships with Care Access Research personnel
Address patient concerns
Interact with patients
Interact with representatives
Interact with investigators
Interact with Care Access Research personnel
Interact with management
Coordinate pre-study site visits
Coordinate site initiation visits
Coordinate monitor visits
Provide onboarding guidance
Provide day-to-day guidance
Identify adverse events
Identify Serious Adverse Events
Notify Principal Investigator
Moderate mixed visit types
Moderate active IP workflows
Moderate AE/SAE workflows
Operate as solo CRC onsite
Prescreen study candidates
Obtain informed consent
Complete visit procedures
Complete basic clinical procedures
Review laboratory results
Ensure investigator review
Discuss study medication
Discuss required procedures
Discuss eligibility criteria
Discuss impact on office flow
Enter data in real time
Record study medication inventory
Record medication dispensation
Record patient compliance
Resolve data management queries
Assist regulatory personnel
Complete regulatory documents
File regulatory documents
Create source documents
Review source documents
Assist with recruitment material planning
Assist with recruitment material creation
Assist in development of recruitment plan
Obtain listing of potential candidates
Call subjects for recruitment
Review protocol amendments
Ensure training requirements are met
Ensure study requirements are met
Communicate clearly verbally
Communicate clearly in writing
Attend Investigator meetings
Own competing priorities
Prioritize competing priorities
Ensure adequate supplies have arrived
How You'll Work.
Team & Collaboration
Work effectively with diverse team
Communication Scope
Verbal communication; Written communication
Applying for this Clinical Research Coordinator II role?
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