Clinical Research Coordinator II (On-site)

• Company DescriptionM3 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 DescriptionThe Clinical Research Coordinator II (CRC II) 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 II independently manages and coordinates day-to-day clinical trial activities, ensuring protocol compliance, data integrity, and operational efficiency.
• The CRC II 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 requirementsMaintain accurate and timely case report forms, source documentation, study charts, and regulatory documentationProvide mentorship, training, and day-to-day oversight to Clinical Research Coordinators and Research AssistantsEnsure all clinical research activities are conducted in compliance with study protocols, GCP guidelines, sponsor requirements, and applicable laws, regulations, policies, and proceduresCollect, review, and enter study data with a high degree of accuracy and attention to detailSupport management in the candidate interview, selection, onboarding, and shadowing processes for new hiresAssist with study start-up activities, ongoing study maintenance, and close-out procedures across assigned studies and team initiativesCollaborate with investigators, sponsors, CROs, and internal departments to facilitate efficient study operations and issue resolutionDemonstrate the ability to independently prioritize workload and adapt to changing study needs and assignmentsServe as a resource for team members regarding study processes, protocol requirements, and site proceduresQualificationsClinical Research Coordinator with 2+ years of experiencePhlebotomy experience is highly preferredExcellent verbal & written communication skillsAbility to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-taskingMust be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA GuidelinesExtensive clinical trial knowledge through education and/or experienceSuccessful completion of GCP Certification and Advanced CRC preferredDetail-orientedFamiliarity with the Code of Federal Regulations as they pertain to human subject protectionStrong interpersonal skillsAdditional InformationAbout 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) matchingDental insuranceDisability insuranceEmployee assistance programFlexible spending accountHealth insuranceLife insurancePaid time offVision insurance*M3 reserves the right to change this job description to meet the business needs of the organization#LI-Onsite#LI-LB1