Clinical Research Coordinator I

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

Prescreen study candidates

Obtain informed consent per Care Access Research SOP .

Follows SOPs/GCP precisely; completes documentation accurately.

Demonstrates empathy; follows patient privacy and safety protocols.

Complete visit procedures in accordance with protocol.

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

Receives structured mentorship; participates in shadowing and skills validation.

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

Low complexity; stable protocols with limited procedures and minimal IP handling.

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

Prioritize activities with specific regard to protocol timelines

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

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

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

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 participants

Other Responsibilities

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.

Attend Investigator meetings as required.

Adapts to new systems; seeks feedback; escalates issues.

Owns assigned tasks; meets deadlines with support.

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

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

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

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)

Executes tasks with supervision; requires frequent review and guidance for visits, consent support, and complex procedures.

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

Communicates clearly with guidance; asks questions; responds timely.

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:

A minimum of 1-year prior Clinical Research Coordinator experience required

Recent phlebotomy experience required

How We Work Together

Location: Position requires onsite work 5 days per week

Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives.

Physical demands associated with this position Include:

Walking, Standing, Sitting, Lifting (Up to and Overhead 25 lbs), and Driving - 20% each

The expected pay range for this role is $55,000 - $85,000 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

Mandatory Employer Disclosures

Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.

Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.

Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.

Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.

Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.