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 Research Assistant plays a key supporting role in ensuring protocol compliance and data quality. Through collaborative efforts with the research team, the Research Assistant helps uphold the integrity of the study 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).
- 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
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.
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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