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Clinical Regulatory Assistant

Company: Aerotek
Location: Summerville
Posted on: April 30, 2021

Job Description:


  • Present front facing personality, will meet and greet patients, answer phones, update emails, print and organize faxes, and other front desk duties as needed
  • Contract participants for appointments, reminders, or other trial requirements
  • Perform clerical duties in the preparation, submission, filing, and maintaining of regulatory documents. File correspondence
  • Extract data from source documents for clinical trials as directed. Collect data and complete case report forms.
  • Entering patient data accurately and in a timely manner in multiple systems
  • Updating patient demographic information, medical history, concomitant medications, etc. into site's CTMS system
  • Assist in requesting and/or printing medical records. Follow-up on requested medical records
  • Notifying of PCP of subject's participation in clinical trial
  • Learn to properly review and evaluate patient medical charts
  • Help update website and social media as needed
  • Order and maintain inventory level for supplies, both for the site and the trial
  • Assist CRC's and patient recruiter with internal/external marketing for study recruitment
  • Assist in preparing regulatory submissions and maintaining the regulatory files
  • Assists in preparation of regulatory documents for interim monitoring visits
  • Ensure proper maintenance of of GCP certificates of for all site personnel
  • Maintaining updates on IATA training on appropriate site personnel
  • Answer incoming calls and directing appropriate locations
  • Maintains a cooperative relationship among healthcare teams by communication, responding to requests, building rapport, participating in team problem solving methodsAdditional Skills & Qualifications:
    • At least 2 year college degree (associates) and 1 year of relevant experience, or equivalent combination
    • Knowledge of medical terminology
    • EDC (Electronic Data Capture) experience preferred
    • Familiarity with chart review and tracking data from charts
    • Experience with phlebotomy/medical laboratory work is a plus
    • Attention to detail
    • Ability to work effectively with wide range of individuals and groups at all levels of authority
    • Excellent interpersonal, oral, and written communication skills are essential
    • Strong clinical thinking and problem solving skills
    • Prior work with clinical research or patient care preferred
    • Must have a strong work ethic, be proactive in identifying tasks that need to be completed
    • Strive for accuracy and quality when completing assignments
    • Excellent computer skills and knowledge of Microsoft Office softwareCandidates from Clinical Trials of South CarolinaExperience Level:Entry Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Summerville , Clinical Regulatory Assistant, Healthcare , Summerville, South Carolina

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