Clinical Research Coordinator II

Responsibilities

Prioritize activities with specific regard to protocol timelines

Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials

Maintain effective relationships with study participants and other care Access Research personnel

Balances protocol needs with patient experience; proactively addresses concerns

Monitors quality metrics; prevents deviations; resolves queries quickly

Interact in a positive, professional manner with patients, .representatives, investigators and Care Access Research personnel and management

Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives

Mentors CRC I peers; provides onboarding and day‑to‑day guidance

Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)

Moderate complexity; mixed visit types, active IP and AE/SAE workflows

Can operate as solo CRC onsite

Prescreen study candidates

Obtain informed consent per Care Access Research SOP

Complete visit procedures in accordance with protocol

Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc

Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion

Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff

Record data legibly and enter in real time on paper or e-source documents

Accurately record study medication inventory, medication dispensation, and patient compliance

Resolve data management queries and correct source data within sponsor provided timelines

Assist regulatory personnel with completion and filing of regulatory documents

Assist in the creation and review of source documents

Assist with planning and creation of appropriate recruitment materials

Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database

Actively work with recruitment team in calling and recruiting subjects

Review and assess protocol (including amendments) for clarity, logistical feasibility

Ensure that all training and study requirements are met prior to trial conduct

Communicate clearly verbally and in writing

Anticipates needs; proposes solutions; manages change effectively

Attend Investigator meetings as required

Owns studies; prioritizes competing demands; mentors CRC I

Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)

Preferred

Bachelor's Degree preferred

Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator

Benefits

For US Full Time Employees: Paid Time Off (PTO) and Company Paid Holidays

For US Full Time Employees: 100% Employer paid medical, dental, and vision insurance plan options

For US Full Time Employees: Health Savings Account and Flexible Spending Accounts

For US Full Time Employees: Bi-weekly HSA employer contribution

For US Full Time Employees: Company paid Short-Term Disability and Long-Term Disability

For US Full Time Employees: 401(k) Retirement Plan, with Company Match

For US Full Time Employees: Relocation Support Provided

Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.

Boston, Massachusetts, USA

https://careaccess.com/

Late Stage

Total Funding

unknown

Key Investors

Biomedical Advanced Research and Development Authority (BARDA)

2024-08-26

Grant

Leadership Team

Ahmad Namvargolian

CEO, Co-Founder

Josh Brandoff

Head of Applied Machine Learning

Recent News

PYMNTS.com

Walmart Health Research Institute to Host Clinical Trials at 4 New Sites

2026-01-23

Business Wire

Care Access and the Association of Black Cardiologists Partner to Expand Heart Health Screenings and Research Opportunities to More Communities

2025-11-19

No-Cost Heart & Kidney Health Screenings Coming to Jacksonville to Detect Dangerous Type of Cholesterol You’ve Probably Never Tested For

Qualifications

Ability to understand and follow institutional SOPs

Excellent working knowledge of medical and research terminology

Excellent working knowledge of federal regulations, good clinical practices (GCP)

Operates independently for most study activities; escalates complex issues as needed

Ability to communicate and work effectively with a diverse team of professionals

Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail

Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel

Critical thinker and problem solver

Friendly, outgoing personality; maintain a positive attitude under pressure

High level of self-motivation and energy

Excellent professional writing and communication skills

Manages stakeholder communications; facilitates visits and meetings

Ability to work independently in a fast-paced environment with minimal supervision

or equivalent combination of education, training and experience

3 years prior Clinical Research Coordinator experience required

Recent phlebotomy experience required

Or equivalent combination of education, training and experience

Bachelor's Degree preferred

Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator

Required skills

Clinical Research Coordination, Clinical Practice (GCP), Phlebotomy, Electronic Data Capture (EDC), Microsoft Word, Microsoft Excel, Federal Regulations

Preferred skills

Bachelor's Degree preferred

Experience

3+ years