Clinical Research Assistant

Company Description:

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. Our board-certified physicians have completed more than 7,000+ successful clinical trials.

Job Description:

The Clinical Research Assistant (RA) supports the daily execution of clinical trial activities under the guidance of site leadership, the Principal Investigator (PI), and the clinical research staff. The Research Assistant plays a key supporting role in ensuring protocol compliance and data quality and prioritizes the safety and well-being of all study participants.

Essential Duties and Responsibilities:

• Maintain clinical supply inventory, including PPE, exam room, and lab supplies; monitor stock levels and coordinate replenishment.
• Ensure exam rooms, lab spaces, and equipment are clean, organized, well-maintained, and visit-ready; maintain equipment logs and temperature records.
• Assist with phlebotomy, sample processing, and preparation/shipment of biological specimens in accordance with protocol and IATA requirements.
• Support study visits by preparing participant charts, lab kits, requisitions, and required documentation.
• Perform protocol-specific clinical tasks as trained and delegated (e.g., vital signs, ECGs, PFTs).
• Accurately collect, document, and enter participant data in source records and EDC systems; assist with query resolution and eDiary reconciliation.
• Assist with participant scheduling, phone screenings, follow-up calls, and visit reminders.
• Support regulatory and study documentation filing, organization, and archiving in compliance with GCP, site SOPs, and sponsor requirements.
• Collaborate with Clinical Research Coordinators and clinical staff to ensure protocol adherence and regulatory compliance.
• Complete all required training (e.g., GCP, OSHA, IATA, site SOPs).

Qualifications:

• At least 2 years of experience working in a healthcare setting
• Phlebotomy experience is highly preferred
• Previous experience as a medical assistant, EMT or LPN/ LVN
• Prior clinical research experience preferred
• Excellent verbal & written communication skills
• Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking
• Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines
• Detail-oriented
• Strong interpersonal skills

Additional Information:

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance