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. While the PI oversees the conduct of the study and the Clinical Research Coordinator (CRC) manages its day-to-day operations, the RA plays a key supporting role in ensuring protocol compliance and data quality. Through collaborative efforts with the research team, the RA helps uphold the integrity of the study and prioritizes the safety and well-being of all study participants.

Essential Duties and Responsibilities:

Including, but not limited to the following:

• Complete all required site and department training (GCP, IATA, OSHA, SOPs).
• Maintain exam rooms and manage clinical supply inventory.
• Ensure trial procedures follow ICH/GCP, federal regulations, site SOPs, and sponsor protocols.
• Review study protocols and perform delegated tasks (vitals, ECGs, PFTs, phlebotomy, sample processing/shipment, EDC entry, eDiary reconciliation, safety follow-ups).
• Manage regulatory documentation, lab area upkeep (temperature logs, centrifuge records, inventory), and resolve data queries.
• Assist with participant screening, scheduling, visit preparation (charts, lab requisitions, kit assembly).
• Accurately collect and document source data per protocol and GCP standards.
• Support archiving of study documentation in compliance with regulatory and sponsor requirements.
• Travel to peripheral/satellite sites to coordinate research activities and oversee visits.

Qualifications

• Associates degree or equivalent of clinical experience.
• Medical assistant, EMT, Certified Pharmacy Technician, LPN/LVN, or Phlebotomist strongly preferred.
• Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs is preferred.
• Successful completion of the GCP certification.
• Prior clinical research experience preferred.
• Prior patient recruitment/community outreach experience preferred.

Additional Information

About M3:

M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.

Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.

Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.

Benefits:

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

*M3 reserves the right to change this job description to meet the business needs of the organization

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