CRC- Clinical Research Coordinator

About the role

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. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

Responsibilities

• Screening of patients for study enrollment
• Patient consents
• Patient follow-up visits
• Documenting in source clinic charts
• Entering data in EDC and answering queries
• Obtaining vital signs and ECGs
• Performing 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
• Requesting and tracking medical record requests
• Updating and maintaining logs, chart filings
• Maintaining & ordering study specific supplies
• Scheduling subjects for study visits and conducting appointment reminders
• Building/updating source as needed
• Conducting monitoring visits and resolving issues as needed in a timely manner
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner
• Filing SAE/Deviation reports to Sponsor and IRB as needed
• Documenting and reporting adverse events
• Reporting non-compliance to appropriate staff in a timely manner
• Maintaining positive and effective communication with clients and team members
• Always practicing ALCOAC principles with all documentation
• Assisting with study recruitment, patient enrollment, and tracking as needed
• Maintaining confidentiality of patients, customers and company information
• Performing all other duties as requested or assigned
• Completing all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.
• Preparing and attending site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
• Setting up, training and maintaining all technology needed for studies

Qualifications

A Medical Assistant diploma, LPN