The Clinical Research Coordinator works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. This role involves patient screening, consents, follow-up visits, and documentation, ensuring all activities adhere to regulatory standards.
Responsibilities
Work in collaboration with other members of the clinical research site team to ensure the execution of assigned studies
Screen patients for study enrollment
Obtain patient consents
Conduct patient follow-up visits
Document in source clinic charts
Enter data in EDC and answer queries
Obtain vital signs and ECGs
Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up
Request and track medical record requests
Update and maintain logs and chart filings
Maintain and order study specific supplies
Schedule subjects for study visits and conduct appointment reminders
Build and update source as needed
Conduct monitoring visits and resolve issues as needed in a timely manner
Ensure study related reports and patient results are reviewed by investigator in a timely manner
File SAE/Deviation reports to Sponsor and IRB as needed
Document and report adverse events
Report non-compliance to appropriate staff in a timely manner
Maintain positive and effective communication with clients and team members
Always practice ALCOAC principles with all documentation
Assist with study recruitment, patient enrollment, and tracking as needed
Maintain confidentiality of patients, customers and company information
Perform all other duties as requested or assigned
Complete all needed activities for study start-up, including completing required training and uploading/printing certificates to file in ISF
Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
Set up, train and maintain all technology needed for studies
Requirements
Medical Assistant diploma, LPN/LVN, EMT credential OR Associate’s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience
Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications
Ability to type proficiently (40+ wpm)
Strong organizational skills and attention to detail
Millions of jobs, with real people getting hired every day
200,000+
New jobs added daily
7,000,000+
Verified job listings
1,000,000+
Tailored applications submitted
Well-developed written and verbal communication skills
Well-developed interpersonal and listening skills
Ability to work well independently as well as with co-workers, subjects, managers and external customers
Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities
Must be professional, respectful of others, self-motivated, and have a strong work ethic
Must possess a high degree of integrity and dependability
Ability to work under minimal supervision, identify problems and implement solutions
Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines
Nice to have:
Proficiency with performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc.
Bi-lingual (English / Spanish) proficiency
Benefits
Medical insurance
Dental insurance
Vision insurance
Life insurance
Short and long-term disability insurance
Health savings accounts
Supplemental insurances
401k plan with a safe harbor match
About the Company
Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. They have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Alcanza Clinical Research is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. They conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Alcanza is a culturally competent organization that values diversity and inclusion.
