Clinical Research Assistant

Job Description
M3 Wake Research Inc. is one of the largest independent clinical research site services companies in North America. Wake Research has 23 owned and managed research sites across 9 states in the US and continues to grow. Due to continued growth and expansion, we are seeking a Clinical Research Assistant for our Atlanta, GA location.

The Clinical Research Assistant (RA) is a research professional working with and under the direction of the clinical research site management, Principal Investigator (PI), and clinical research staff. While the PI is primarily responsible for the overall conduct and management of the clinical trial, the Research Assistant supports the clinical research staff with daily clinical trial activities and plays an important role in the conduct of the study. By performing these duties, the research assistant works with the PI, site management and clinical research staff to support all aspects related to the conduct of clinical trials. The primary concern of all Wake Research personnel is the protection of study subjects.

Requirements

General / Administrative

• Completes all site training requirements including but not limited to: GCP training, IATA training, OSHA training, site SOP review, individual department training.
• Completes training on and shows competency with clinical skills as delegated (phlebotomy, vital signs, ECG, PFTs etc).
• Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of noncompliance to the lead study coordinator or site management.
• Assists with coordinating and facilitating monitoring visits.

Study Preparation

• Reviews and comprehends assigned protocol.
• Attends research meetings for assigned studies as required.
• Prepares study materials for assigned studies. These study materials may include but are not limited to: source document creation, adverse event and concomitant medication logs, drug/device accountability logs, subject visit spreadsheets, chart preparation.
• Assists with organizing study files, including but not limited to, regulatory binders and other materials.
• Attend site initiation visit (SIV) and attends protocol training/team meetings prior to start of screening.
• Communicates with lead study coordinator to help ensure there are no delays in the start-up of assigned study. (i.e. all required training has been completed by appropriate staff, all study supplies have been received, IRB approval has been obtained, etc.).

Conduct of Research

• Assist with recruitment strategies and collaborate with recruitment department to ensure suitable subjects meet study criteria.
• Performs study related procedures according to study protocol as trained (i.e. Vital signs, ECG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator).
• Collects data on source documentation as required by the protocol. Assists with timely completion of Case Report Forms.
• Helps to Maintain regulatory files throughout the conduct of the entire trial.
• Reviews study supply inventory to ensure site has adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
• Maintains effective and ongoing communication with Lead study coordinator, site management and PI during the course of the study.
• Works with lead study coordinator to assist with resolving any issues that may arise during the conduct of the study or during a monitor visit. Involve management with any issues where assistance may be required.

Project Closeout

• Assist lead study coordinator with close-out visit activities (i.e. drug reconciliation, drug return, IRB close-out report, regulatory document filing)

Benefits

• Competitive salary
• Advancement and career opportunities
• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance