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Sunday, April 29, 2012

Clinical Research Associate II Medpace Clinical Research India Pvt. Limited in Navi Mumbai


Job Description
• Verify that the rights and well -being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s).

• Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Medpace/Sponsor Standard Operating Procedures (SOPs).

• Serve as the primary resource to the clinical investigator and site staff.


• Maintain close collaboration, interaction, and effective working relationships with Medpace internal cross-functional teams.

• Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and Medpace monitoring portal.

• Excellent communication skills, both written and verbal.

• Operational knowledge of MS office and other basic windows software.
Salary:
Not Disclosed by Recruiter
Industry:
Medical, Healthcare, Hospitals
Functional Area:
Healthcare, Medical, R&D
Role Category:
R&D
Role:
Clinical Research Associate/ Scientist
Keyskills:
Clinical Research, Clinical Research Associate
Desired Candidate Profile
Education:
(UG - B.Sc) AND (PG - Any PG Course)
• Bachelor of Science (Post Graduation will be preferred) with prior independent clinical research monitoring for Investigational Medicinal Product and Medical Devices and site management experience for at least 2 years .

• Demonstrate comprehensive knowledge of Good Clinical Practice Guidelines and Sponsor Standard Operating Procedures (SOPs) (as appropriate);

• Ability to interact with other departments and Sponsors on project-related issues;

• Ability to carry out the job duties without close supervision and is expected to work independently.

• Highly self-motivated, result oriented individuals with positive attitude and independent judgment.

• Ability to travel extensively up to 70%
Company Profile
Medpace Clinical Research India Pvt. Limited
http://www.medpace.com
Medpace is a leading global full-service clinical research organization providing Phase I-IV core development services for drug, biologic, and device programs. With medical and regulatory expertise in multiple therapeutic specialties, Medpace has assembled the industry’s most experienced and therapeutically focused teams to execute at every level of the company’s operations, providing complete and seamless drug development services.
Medpace creates strategic partnerships with pharmaceutical and biotechnology companies to provide the most efficient and cost-effective path to drug development – from program planning and execution to product approval.

With more than 1000 employees and clinical trial experience in over 40 countries, Medpace has the global reach and capability to conduct studies and navigate regulatory requirements worldwide. In addition to Phase II-IV development services, Medpace provides Phase I / IIA clinical services from Medpace Clinical Pharmacology, central laboratory and therapeutically specialized testing from Medpace Reference Laboratories, complete bioanalytical services in all stages of drug development from Medpace Bioanalytical Laboratories, centralized imaging core laboratory management and reading from Imagepace, and medical device development from Medpace Medical Device.
Contact Details
Executive Name:
HR
Contact Company:
Medpace Inc
Email Address:




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