Alcanza Clinical Research

Clinical Research Coordinator

Alcanza Clinical Research

full-time

Posted on:

Origin:  • 🇺🇸 United States • South Carolina

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Job Level

Junior

Tech Stack

Google Cloud Platform

About the role

  • In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
  • Screening of patients for study enrollment.
  • Patient consents and patient follow-up visits.
  • Documenting in source clinic charts and building/updating source as needed.
  • Entering data in EDC and answering queries.
  • Obtaining vital signs and ECGs.
  • May 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.
  • 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.
  • 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 timely manner.
  • Maintaining positive and effective communication with clients and team members; maintaining confidentiality of patients, customers and company information.
  • Complete all needed activities for study start-up, including completing required training, uploading/printing certificates to file in ISF; prepare and attend site initiation visits (SIVs) and Investigator Meetings (IMs) as needed.
  • May assist with study recruitment, patient enrollment, and tracking as needed; may set up, train and maintain all technology needed for studies.
  • Perform all other duties as requested or assigned.

Requirements

  • A 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, is required.
  • Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred.
  • Bi-lingual (English / Spanish) proficiency is a plus.
  • BLS certified/preferred.
  • Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the 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 and the 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.