Senior Clinical Research Associate (Sr CRA)

Advanced Clinical

Posted: January 15, 2016

Job ID: 142

Job Summary

Term: Contract
Job Roles: Other
Therapeutic Experience: Other
Required Education: BS degree in a life science or related field
Required Experience: 3 years
Compensation: hourly

Job Description

Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRFs, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CROs. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate. 0-3 Years Experience Level.
- planning study conduct, writing study protocols, designing CRFs, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CROs.

• Manage all operational study parameters including, but not limited to, clinical study start-
up activities, clinical supplies preparation, enrollment, data collection, and study budgets.
• Supervise monitoring activities of study data verification on source documentation and
case report forms (CRFs) to ensure compliance with the study protocols, GCPs, and
SOPs; Ensure data discrepancies are identified and resolved
• Prepare and oversee all study-related clinical documents including, but not limited to,
informed consent forms, site training materials, CRFs, clinical monitoring plans, source
document templates, and data audit worksheets
• Co-monitor on-site monitoring visits, including site qualification, initiation, interim, co-
monitoring with CRO, and close-out visits as necessary
• Up to 25% travel expectation, domestic
• BS degree in a life science or related field
• Experience as a Clinical Research Associate or similar role
• Medical device, biotech or pharmaceutical research experience
• Extensive experience in the preparation, monitoring, and execution of clinical studies
• 3 to 4 years of successful, wide-ranging experience managing contract research
organization (CRO) team members and study sites, including study start-up through study
maintenance and close out, with a demonstrated understanding of the data management
components needed in a trial, including enrollment projections, management and
• Superb verbal and written communication skills
• Excellent organizational skills along with strong attention to detail
• Ability to work both independently and collaboratively with cross-functional teams
• Highly proficient with Microsoft Office Suite
• Ability to utilize critical thinking to analyze problems which may require multiple factors
• Experience in a start-up or early stage company environment
• Experience in electrophysiology or cardiovascular preferred
• Project and people management experience

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439
mouranos@advancedclinical.com
www.linkedin.com/in/mohammadouranos/
www.advancedclinical.com

Be Advanced. Advanced solutions for a better clinical experience.

Referrals are crucial to our success and we offer a referral bonus, from $1000 to $3000, should we successfully deploy someone you introduce.

Look up active jobs on our website & email me the job order # directly! http://www.advancedclinical.com/find-a-job