Clinical Research Associate II
Proclinical is currently recruiting for a Clinical Research Associate for a medical device development firm located in San Diego, CA. Successful candidate will manage and monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.
- Perform the management of 1-2 Clinical Studies at a time.
- Serve as the main contact and liaison for project specific client and communicates with investigative sites.
- Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
- Research and learn project indication.
- Participate in team meetings with clients and keep project team members informed of study progress, issues and potential timeline delays by preparing weekly updates.
- Identify and negotiate contract and budget of clinical sites for the project.
- Generate clinical study documents such as Protocols, ICFs, Source Documents, and Monitoring Plans.
- Review vendor contracts and budgets.
- Develop and manage study timelines.
- Complete, maintain and close IRB submissions.
- Ensure CRAs assigned to project are scheduled appropriately for SIVs, IMVs and SCVs.
- Assist Clinical Trial Assistant with generating and ordering Study supplies.
- Perform essential document site file reconciliation. Perform source document verification and query resolution.
- Assess IP accountability, dispensation, and compliance at the investigative sites.
- Ensure all required training is completed and documented.
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
- May be assigned additional Clinical Operations tasks.
- Help create a fun, rewarding and collaborative environment.
Skills and Requirements:
- BS in the Life Sciences or related field required; advanced degree (Master's or above) preferred.
- Pursuing a certification as a CCRP or CCRA.
- 5+ years as a CRA including the ability to interact effectively with investigators and cross-functional teams; in vitro diagnostics experience is preferred.
- Thorough knowledge of GCP, GLP, ICH guidelines and other U.S. and international clinical regulatory requirements.
- Strong work ethic and demonstrated ability to deliver assignments on time.
- Ability to travel (up to 80%).
- Ability to handle difficult situations professionally and maintain a professional and caring demeanor.
- Proven ability to collaborate in a team environment and work independently.
- Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.
- Must be responsible, creative and highly motivated.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Susan Chapman at (+1) 646-542-0158 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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