Clinical Research Coordinator (On-site)

M3 Wake Research; Raleigh (NC); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Disability insurance

Employee assistance program

Flexible spending account

Health insurance

Life insurance

Paid time off

Vision insurance

Job summary

M3 Wake Research in Raleigh, NC is hiring a Clinical Research Coordinator II to support day-to-day trial activities and ensure protocol compliance. You will work closely with the PI and site management to drive data integrity and study execution on-site.

Responsibilities include screening participants, managing case report forms, mentoring staff, and coordinating start-up, maintenance, and close-out activities across trials while upholding HIPAA, GCP, and CFR requirements.

Qualifications

• 2+ years as Clinical Research Coordinator
• Phlebotomy experience preferred
• Excellent verbal and written communication
• Ability to learn quickly and follow complex protocols
• Maintain HIPAA confidentiality and compliance
• Strong knowledge of GCP and CFR as they relate to human subjects
• Detail-oriented with strong data accuracy
• Strong interpersonal skills

Responsibilities

• Screen and review potential study participant eligibility per protocol
• Maintain case report forms, source documentation, study charts, and regulatory documentation
• Mentor and oversee Clinical Research Coordinators and Research Assistants
• Ensure activities comply with study protocols, GCP, sponsor requirements, and applicable laws
• Collect and enter study data with high accuracy
• Support candidate interviewing, onboarding, and shadowing processes
• Assist with study start-up, maintenance, and close-out procedures
• Collaborate with investigators, sponsors, CROs, and internal departments to resolve issues
• Prioritize workload and adapt to changing study needs
• Serve as a resource on study processes and site procedures

Skills

Phlebotomy

Communication skills

HIPAA compliance

Multi-tasking

Attention to detail

Interpersonal skills

Study protocol literacy

CFR familiarity

Education

GCP Certification

Advanced CRC training

Job 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. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Due to our continued growth, we are hiring for a Clinical Research Coordinator II at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC.

Job Description

The Clinical Research Coordinator (CRC) is an experienced research professional who works collaboratively with clinical research site management and the Principal Investigator (PI) to support the successful execution of clinical trials. While the PI maintains overall responsibility for the conduct of the study, the CRC independently manages and coordinates day-to-day clinical trial activities, ensuring protocol compliance, data integrity, and operational efficiency. The CRC also serves as a resource and mentor to research staff and contributes to study oversight, workflow optimization, and team development.

Essential Duties and 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

Qualifications

• Clinical Research Coordinator with 2+ years of experience
• Phlebotomy experience is highly 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
• Extensive clinical trial knowledge through education and/or experience
• Successful completion of GCP Certification and Advanced CRC preferred
• Detail-oriented
• Familiarity with the Code of Federal Regulations as they pertain to human subject protection
• Strong interpersonal skills

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