Clinical Research Assistant

Clinical Research Assistant

Department: Operations


Employment Type: Full Time

Location: Coastal Carolina Research Center | Charleston, SC

Reporting To: Nikki Shebelskie

Description

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 have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.


The Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site.

Key Responsibilities

Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to:

• Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol:
  • Assists with the basic screening of patients for study enrollment;
  • Assists with patient follow-up visits;
  • Documents in source clinic charts;
  • Enters data in EDC and answers queries;
  • Obtains vital signs and ECGs;
  • May perform blood draws;
  • 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;
  • Enters data in EDC and answers queries;
  • Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and
  • Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed;
• Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner.
• Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed;
• Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and
• Perform all other duties as requested or assigned.

Skills, Knowledge and Expertise

Minimum Qualifications : A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus.

Required Skills:

• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm).
• Must possess 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.

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 date of hire.
• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.