M3 Wake Research ยท 18 hours ago
Research Assistant/ Laboratory Coordinator
M3 Wake Research, an M3USA Company, is a leading clinical research organization with a vast network of investigational sites. They are seeking a Research Assistant/Laboratory Coordinator to support daily clinical trial activities under the guidance of site leadership, ensuring protocol compliance and data quality while prioritizing participant safety.
Health CareMedicalPharmaceutical
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)
Qualification
Required
At least 2 years of experience working in a healthcare setting
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
Extensive clinical trial knowledge through education and/or experience
Detail-oriented
Strong interpersonal skills
Preferred
Phlebotomy experience is highly preferred
Previous experience as a medical assistant, EMT or LPN/ LVN
Prior clinical research experience preferred
Successful completion of GCP Certification and Advanced CRC preferred
Familiarity with the Code of Federal Regulations as they pertain to human subject protection
Benefits
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance