Clinical Research Assistant

Piedmont HealthCare PA • Charlotte, NC

11h • Hybrid

About The Position

The Research Assistant coordinates and supports the clinical site in planning and executing multiple phase clinical trials. This role works with the Clinical Research Coordinator to perform study activities related to pre-trial assessment(s), start up, active phase, and closeout. This includes preparing and submitting sponsor and regulatory documents; recruiting and pre-screening participants; collecting study data, including specimen samples, according to identified protocols and organizing and managing it in study folders/binders, whether manually and/or electronically. The position also participates in pre-trial assessments, initiation visits and investigator meetings, as appropriate and assists in communicating with and coordinating visits by study monitors. Additionally, the role involves processing regulatory packets for submission to the sponsor, which may include obtaining patient signatures for protocols/amendments, updating consent forms with site-specific information, collecting completed FDA forms, updated C.V.s and medical licenses for investigators and other personnel involved in studies, and responding to requests related to advertisements, indemnification, completed W-9 Forms, appropriate signatures on Clinical Trial Agreements, and correspondence/questionnaires to IRB requesting review and approval for site and site information form. The assistant may attend IRB meetings when necessary.

Requirements

• Bachelor’s degree in science or health-related field preferred
• Two years clinical research experience desired
• Clinical research certification (ACRP or SOCRA preferred).
• Knowledge of all applicable laws, policies and procedures with regard to research.
• Knowledge of common safety hazards and precautions to establish/maintain a safe work environment.
• Skill in applying and modifying the principles, methods and techniques of professional research to provide ongoing patient care.
• Skill in identifying problems and recommending solutions.
• Skill in preparing/maintaining records, writing reports and responding to correspondence.
• Ability to maintain quality control standards.
• Ability to react calmly and effectively in all situations.
• Ability to communicate clearly.

Responsibilities

• Works with Clinical Research Coordinator to perform study activities related to pre-trial assessment(s), start up, active phase and the closeout.
• Prepares and submits sponsor and regulatory documents.
• Recruits and pre-screens participants.
• Collects study data, including specimen samples, according to identified protocols.
• Organizes and manages study data in study folders/binders, whether manually and/or electronically.
• Participates in pre-trial assessments, initiation visits and investigator meetings, as appropriate.
• Assists in communicating with and coordinating visits by study monitors.
• Processes regulatory packets for submission to the sponsor.
• Attends IRB meetings when necessary.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level