Medical Monitor, MD

Advanced Clinical Services LLC has as an outstanding one-year consulting opportunity for a Board-Certified MD with 5 years of industry experience working as a Medical Monitor. The physician joining us must be able to work at our client?s Minneapolis-St. Paul site 50-75% of each week, overseeing their dermatology clinical program. This position does offer a lucrative salary and participation in Advanced Clinical's Benefit program.Design, develop, prepare and initiate clinical study protocols and required documentation in compliance with project plans, federal regulations, GCP and good medical practiceProvide medical and scientific input to review of clinical data, patient medical safety data and laboratory values; maintain an ongoing assessment of the safety profile, and efficacy data Provide medical surveillance on Serious Adverse Event (SAE) reporting, and follow-ups. Work with Regulatory Deptartment for the submission of IND safety reportsParticipate in the planning, writing and review of Clinical Study Reports, regulatory updates and submissionsContinuing research of new scientific developments, competitor products and research in the area of anti-infective diseases Analyze and interpret study data and prepare reports for FDA and publication Support corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees Publish study data and present study data at professional conferences. Serve as the primary medical contact with academic experts, collaborators and opinion leadersParticipate as an active member of multidisciplinary teams to successfully achieve corporate goals

Education:MD degree, completed residency and board certification in Internal or General MedicineSub-specialty training in Dermatology is preferred

Qualifications:Demonstrated experience in review, compilation and analysis of safety data, including SAEs and product withdrawalDemonstrated proficiency in the implementation, monitoring and management of clinical trials, timelines and budgetsDemonstrated experience in the operational aspects of a clinical study including the review of eCRFs and CRFs Participation in a clinical trial program through NDA Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essentialDemonstrated leadership skills; ability to establish excellent collaborative internal and external relationshipsExcellent oral and written skills, including manuscript writing

About Advanced Clinical Services LLC:

Since 1994 Advanced Clinical Services LLC has been an integral member of the clinical research community, providing national staffing services that unite clinical trial sponsors and CROs with experienced professionals. As an Advanced Clinical Services candidate, you will receive personal service from staffing professionals focused exclusively in the area of clinical research. We use our clinical research expertise, knowledge, pipeline, and strong industry relationships to provide you with matched opportunities. Our corporate headquarters is located in Downers Grove, IL and we have an office in San Francisco, CA.

EOE/AA M/F/D/V

We invite you to visit our Web Page at: http://www.advancedclinical.com