How This Role Makes a DifferenceThe 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 candidatesย
- Obtain informed consent per Care Access Research SOP .ย
- Follows SOPs/GCP precisely; completes documentation accurately.ย
- Demonstrates empathy; follows patient privacy and safety protocols.ย
- Complete visit procedures in accordance with protocol.ย
- Complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.ย
- Receives structured mentorship; participates in shadowing and skills validation.ย
- Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.ย
- Low complexity; stable protocols with limited procedures and minimal IP handling.ย
- Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.ย
- Prioritize activities with specific regard to protocol timelinesย
- Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.ย
- Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.ย
- Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)ย
- Documentation
- Record data legibly and enter in real time on paper or e-source documentsย
- Accurately record study medication inventory, medication dispensation, and patient compliance.ย
- Resolve data management queries and correct source data within sponsor provided timelinesย
- Assist regulatory personnel with completion and filing of regulatory documents.ย
- Assist in the creation and review of source documents.ย
- Patient Recruitmentย
- Assistย with planning and creation ofย appropriate recruitmentย materials.ย
- Assistย inย developmentย of recruitment plan and obtainย listingย of potential candidates to contact fromย subjectย database.ย
- Actively work with recruitment team in calling and recruitingย participants
- Other Responsibilities
- Review and assess protocol (including amendments) for clarity, logistical feasibilityย
- Ensure that all training and study requirements are met prior to trial conduct.ย
- Communicate clearly verbally and in writing.ย
- Attend Investigator meetings as required.ย
- Adapts to new systems; seeks feedback; escalates issues.ย
- Owns assigned tasks; meets deadlines with support.ย
- Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)ย
- Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.ย
- Maintain effective relationships with study participants and other care Access Research personnel.ย
The Expertise Required- Ability to understand and follow institutional SOPs.ย
- Excellent working knowledge of medical and research terminologyย
- Excellent working knowledge of federal regulations, good clinical practices (GCP)ย
- Executes tasks with supervision; requires frequent review and guidance for visits, consent support, and complex procedures.ย
- Ability to communicate and work effectively with a diverse team of professionals.ย
- Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detailย
- Strong computer skills withย demonstratedย abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.ย
- Critical thinker and problem solverย
- Friendly, outgoing personality;ย maintainย a positive attitude under pressure.ย
- High levelย of self-motivation and energyย
- Excellent professional writing and communication skillsย
- Communicates clearly with guidance; asks questions; respondsย timely.ย
- Ability to work independently in a fast-paced environment with minimal supervision.ย
Certifications/Licenses, Education, and Experience:
- Minimum Education:
- Bachelor's Degree preferred, or equivalent combination of education, training, and experience.ย
- Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examinersย
- Minimum Experience:
- 1-year prior Clinical Research Coordinator experience requiredย
- Recent phlebotomy experience requiredย
How We Work Together- Location: Position requires onsite work 5 days per weekย
- 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:ย
- 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 Matchย