- Assisting trial Investigator in screening and review of potential study participants eligibility
- Maintaining case report forms, charts and documentation
- Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants
- Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements
- Collecting and entering data as necessary
- Assist management with potential new hire selection and shadowing process
- Assist with study start-up, maintenance, and close-out of studies as needed for those on the team
- Ability to be flexible with study assignments
- Clinical Research Coordinator with 2+ years of experience
- Phlebotomy & EKG experience strongly 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
- 401(k), 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
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Clinical Research Coordinator - Irvine - M3 Wake Research
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 at Wake Research, an M3 company. This position is on-site and located in Irvine, CA.
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance 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 clinical trial activities and plays a critical role in the conduct of the study.
Essential Duties and Responsibilities:
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:
*This position offers a competitive pay rate of $30–$40 per hour.
*M3 reserves the right to change this job description to meet the business needs of the organization
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