Clinical Research Coordinator

Alcanza Clinical Research•North Charleston, SC

31d•Onsite

About The Position

The Clinical Research Coordinator (CRC) works with other members of the clinical research site team to execute assigned studies in compliance with GCP, ICH, HIPAA, FDA regulations, and SOPs. The position is based at Coastal Carolina Research Center in Charleston, South Carolina, and reports to Nikki Shebelskie. Alcanza is a growing multi-site, multi-phase clinical research company with locations in multiple states and Puerto Rico. Its studies span Phase I–IV and therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine.

Requirements

Medical Assistant diploma, LPN/LVN credential, EMT credential, or associate degree, and at least one year of clinical research or clinical experience; an equivalent combination of education and experience is also accepted.
Proficiency with computer applications, including Microsoft applications, email, electronic health records, and web applications.
Ability to type at least 40 words per minute.
Ability to perform basic clinical procedures such as blood pressure measurements, vital signs, EKGs, and phlebotomy.
Strong organizational skills and attention to detail.
Well-developed written and verbal communication skills.
Well-developed interpersonal and listening skills, and ability to work independently and with coworkers, subjects, managers, and external customers.
Ability to handle multiple tasks and adapt to changing workloads and priorities.
Professionalism, respect for others, self-motivation, and a strong work ethic.
High degree of integrity and dependability.
Ability to work under minimal supervision, identify problems, and implement solutions.
Ability to handle sensitive information confidentially and professionally in compliance with HIPAA guidelines.

Nice To Haves

Proficiency in English and Spanish.
Proficiency with basic clinical procedures such as blood pressure measurements, vital signs, EKGs, and phlebotomy is highly preferred.

Responsibilities

Screen patients for study enrollment and obtain patient consents.
Conduct patient follow-up visits and schedule study visits, including appointment reminders.
Document study information in source clinic charts and build or update source documents as needed.
Enter data in EDC systems and answer queries.
Obtain vital signs and ECGs; perform basic laboratory procedures as required by protocol, including blood specimen collection, centrifuge operation, specimen storage and shipping, specimen accountability, and arranging courier pickup.
Request and track medical records.
Update and maintain logs and chart files.
Maintain and order study-specific supplies.
Conduct monitoring visits and resolve issues in a timely manner.
Ensure study-related reports and patient results are reviewed by the investigator in a timely manner.
File SAE and deviation reports with the 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.
Follow ALCOAC principles in all documentation.
Assist with study recruitment, patient enrollment, and tracking as needed.
Maintain confidentiality of patient, customer, and company information.
Complete study start-up activities, including required training and filing certificates in the ISF.
Prepare for and attend site initiation visits and investigator meetings as needed.
Set up, train users on, and maintain study-related technology as needed.
Perform other duties as requested or assigned.