Clinical Research Coordinator II

About the Role

Under the direction of the Site Manager/Director and the Principal/Sub Investigators, the Clinical Research Coordinator II conducts clinical research activities according to the study protocol, company processes & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines. The Clinical Research Coordinator (CRC) ensures the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs.

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 conduct research across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine.

Responsibilities

• Screening of patients for study enrollment
• Obtaining patient consents
• Conducting 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 and ordering study-specific supplies
• Scheduling subjects for study visits and conducting appointment reminders
• Building/updating source as needed
• Conducting monitoring visits and resolving issues in a timely manner
• Ensuring study-related reports and patient results are reviewed by the investigator promptly
• 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
• Practicing ALCOAC principles with all documentation
• Completing all needed activities for study start-up, including required training and uploading/printing certificates to file in ISF
• Preparing for and attending site initiation visits (SIVs) and Investigator Meetings (IMs), as needed
• Handling all IRB functions for assigned studies independently or with an assigned regulatory team member
• Assisting with training new research assistants and coordinators
• Assisting with scheduling and planning for visit capacity for assigned studies
• Setting up, training, and maintaining all technology needed for studies
• Assisting with study recruitment, patient enrollment, and tracking as needed
• Handling more complex study assignments and volumes
• Participating in community outreach/education events
• Maintaining confidentiality of patients, customers, and company information
• Performing all other duties as requested or assigned

Requirements

A Medical Assistant diploma, LPN/LVN, EMT credential AND 2+ years of clinical research coordination experience, OR an equivalent combination of education and experience, is required.

Qualifications

• Proficiency with performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc. (highly preferred)
• CCRC or CCRP credential (preferred)
• BLS certification (preferred)
• Bi-lingual (English/Spanish) proficiency (a plus)

Skills

• Proficiency with computer applications such as Microsoft applications, email, electronic health records, and 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
• Professional, respectful of others, self-motivated, and strong work ethic
• 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, in compliance with HIPAA guidelines

Benefits

Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following the date of hire. Benefits include:

• Medical, dental, and vision insurance
• Life insurance
• Short and long-term disability insurance
• Health savings accounts
• Supplemental insurances
• 401k plan with a safe harbor match