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Site Start Up - Clinical Research Associate Position vacant at PPD, India

Description

Duties and Responsibilities (according to relevant guidelines, laws and SOPs):
 
  1.  Identify potential investigators in collaboration with the Sponsor, Project Manager, Clinical Team Manager and Clinical Management, as appropriate.
  2. Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites.
  3. As necessary, support the Clinical Submission Specialist(s) with the preparation and submission of regulatory, ethics committee and provincial applications and regulatory packages.
  4. As necessary, support the Clinical Submissions Specialist(s) to ensure the proper essential documents are in place prior to trial start-up; to assist in the preparation of Regulatory Compliance Review packages.
  5. Facilitate, in conjunction with the Clinical Contracts Specialist(s) the administrative set-up of sites, laboratories, storage facilities, equipment, etc.
  6.  Enter and maintain trial status information relating to start-up activities onto tracking databases (e.g. CASCADE) in an accurate and timely manner.
  7.  Provide start-up status tracking and progress reports as required to the Project Manager or Clinical Team Manager.
  8. Upon completion of evaluation visits, to clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards.
  9. Maintain a working knowledge of ICH GCP, Corporate SOP/WPDs and applicable client SOPs.
  10. Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic communication.
  11. Facilitate and respond to company, client and regulatory audits where required.
  12. Contribute to the start-up team by assisting in preparation of project tools and sharing ideas and suggestions with team members.
  13. Support the coordination of country-level feasibility activities, as required, in accordance with agreed timelines.
Start Up Clinical Research Associate: Performs and coordinates Identification and selection of qualified study sites, site evaluation visits in accordance with ICH GCP and FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites. Works in conjunction with the Clinical Submissions Specialist(s) and Clinical Contracts Specialist(s) to prepare investigational sites for initiation. Represents PPD in the global medical research community and develops collaborative relationships with investigational sites.
 
Supports local Clinical Management in the mentorship, training and work direction of local start-up team members. Identifies and suggests potential process improvements. Provides feedback on tools, processes and procedures. Acts as a point of reference for operational and role-specific questions. May assist management team with certain project management functions.
 
Career Ladder: SUCRA-I, II, Senior, Prinicipal SUCRA, Clinical Manager-SU, if perfomance is consistently exceeding expectations and development of competency level of next ladder.

Qualifications

  1. Bachelor's or higher graduate degree in a science related field, licensed or certified health care training or equivalent experience.
  2. Minimum of 3 years of monitoring experience.

Job: Clinical Management

Primary LocationAsia Pacific-India-Maharashtra-Mumbai

OrganizationClin Dev-India (CLDIN)

RecruiterPratibha Bilay

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Friday , 16   December , 2011