Clinical Research Coordinator II

How This Role Makes a Difference

The Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance.

How You'll Make An Impact

Patient Coordination

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.

Documentation

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.

Patient Recruitment

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)

The Expertise Required

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.

Certifications/Licenses, Education, and Experience:

Minimum Education:

Bachelor’s Degree preferred, or equivalent combination of education, training and experience.

Minimum Experience:

3 years prior Clinical Research Coordinator experience required

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

Recent phlebotomy experience required

How We Work Together

Location: This is an on-site position with regional commute requirements

Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.

Type of travel required: ​Regional (within 100 miles)​

Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

Walking, Standing, Sitting, Lifting (up to 25lbs and overhead), Driving - 20%

The expected pay range for this role is $60,000 - $90,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)

Paid Time Off (PTO) and Company Paid Holidays

100% Employer paid medical, dental, and vision insurance plan options

Health Savings Account and Flexible Spending Accounts

Bi-weekly HSA employer contribution

Company paid Short-Term Disability and Long-Term Disability

401(k) Retirement Plan, with Company Match

Relocation Support Provided