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Form of workCompany Description
M3 Wake Research 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.
Job Description
We are looking for an Entry LevelClinical Research Coordinator (CRC) to join our growing team. This position is fully on-site.
TheClinical Research Coordinator (CRC) is a specialized research professional working with, and under the direction of, the Clinical Research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates, and coordinates the daily trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, sponsor, and clinical trial site to support and ensure compliance related to all aspects of the clinical study. The primary concern of all Wake Research personnel is the protection of the study subjects.
Essential Duties and Responsibilities:
- Completes all site training requirements, including but not limited to, GCP training, IATA training, OSHA training, site SOP review, and individual department training.
- Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
- Coordinates with site management/PI to help ensure that Clinical Research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
- Reviews and adheres to assigned protocol, e.g., study procedures and timelines, inclusion and exclusion criteria.
- Attends investigator meetings for assigned studies as required. Some travel may be required.
- Maintains organized study files, including but not limited to regulatory binders, source documents and other materials.
- Attends PSVs, SIVs, IMVs, and COVs as required.
- Begins to learn process of regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
- Assist with recruitment strategies and collaborate with recruitment department to ensure suitable subjects meet study criteria and enrolment goals are met.
- In accordance with site’s informed consent SOP, participates in the informed consent process with research participants by confirming ICF was executed and documented appropriately.
- Performs study-related procedures that have been trained/delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
- Assists with timely completion of case report forms, if appropriately delegated/trained.
- Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
- When required, has professional and ongoing communication with sponsor, sponsor representatives, research participants and investigators during the study and documents accordingly.
- Assists fellow co-workers with studies as time and ability permits or as management delegates.
- Schedules secure storage of study documents with management once close-out visit has been performed and reconciliation of all study documents has occurred.
Qualifications
- Clinical skills, including the ability to perform phlebotomy
- Excellent communication and organizational skills
- Detail-oriented
- Strong interpersonal skills
- Strong computer skills
Additional Information
M3 Wake Research Benefits:
As a key member of our team, you will enjoy an attractive compensation and benefits package, reflective of your skills and experience, and a dynamic work culture. Highlights include:
- 401(k), 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
*This position offers compensation of $15.00-$23.00 per hour.
About M3USA
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. Embrace the chance to drive change with M3 USA.
*M3 reserves the right to change this job description to meet the business needs of the organization
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