About This Role
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
- 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.
