Clinical Research Coordinator

M3 Wake Research, an M3USA Company, is an integrated network of investigational sites supporting clinical research for biopharmaceutical, biotechnology, medical device, pharmaceutical, and clinical research organizations. The Clinical Research Coordinator II independently manages and coordinates day-to-day clinical trial activities, ensuring protocol compliance, data integrity, and operational efficiency while mentoring research staff and supporting study oversight.

Apps

• Healthcare
• Telecom & Communications
• Marketing
• Health Care
• Internet
• Medical
• Insider Connection @M3 USA
• 2 email credits available today
• Beyond your network
• Vlad Mendelson & 1 connections
• From your previous company

Responsibilities

• Assist the Investigator in screening and reviewing potential study participant eligibility in accordance with protocol requirements
• Maintain accurate and timely case report forms, source documentation, study charts, and regulatory documentation
• Provide mentorship, training, and day-to-day oversight to Clinical Research Coordinators and Research Assistants
• Ensure all clinical research activities are conducted in compliance with study protocols, GCP guidelines, sponsor requirements, and applicable laws, regulations, policies, and procedures
• Collect, review, and enter study data with a high degree of accuracy and attention to detail
• Support management in the candidate interview, selection, onboarding, and shadowing processes for new hires
• Assist with study start-up activities, ongoing study maintenance, and close-out procedures across assigned studies and team initiatives
• Collaborate with investigators, sponsors, CROs, and internal departments to facilitate efficient study operations and issue resolution
• Demonstrate the ability to independently prioritize workload and adapt to changing study needs and assignments
• Serve as a resource for team members regarding study processes, protocol requirements, and site procedures

Preferred

• Phlebotomy experience is highly preferred
• Successful completion of GCP Certification and Advanced CRC preferred

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
• M3 USA believes in growth, for our company and for the people who drive it's success.
• Fort Washington, Pennsylvania, USA
• https://www.m3.com/
• Growth Stage
• Leadership Team
• Marina Lamitina, MBA, MA
• Chief Human Resources Officer
• Recent News
• m3.com
• M3, Inc. (Headquarters: Tokyo, Japan; CEO: Itaru Tanimura; URL: https://corporate.m3.com/; “M3”
• 2022-06-10
• MandASoft
• M3.com, acquired MirVracha LCC
• 2022-02-04
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Qualifications

• Clinical Research Coordinator with 2+ years of experience
• 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
• Familiarity with the Code of Federal Regulations as they pertain to human subject protection
• Strong interpersonal skills
• Phlebotomy experience is highly preferred
• Successful completion of GCP Certification and Advanced CRC preferred

Required skills

• Clinical trial management, Code of Federal Regulations for human subject protection, HIPAA compliance, Phlebotomy

Preferred skills

• Phlebotomy experience is highly preferred

Experience

• 2+ years