At PPD, you'll have the freedom to try new ideas and the ability to do something truly great. In our environment, innovation is encouraged. That's why the world's leading pharmaceutical and biotechnology companies come to us for discovery and development services. And why PPD is the best choice for you and for your career. CRA (Level II)- Late Phase Description
Position requires a minimum of 1 year traveling site monitoring experience along with experience in Women's Health. Experience in phase IIIB, IV and/or Observational Studies preferred.
Performs all aspects of in-house site management on assigned registries/compliance programs in accordance with Good Clinical Practices and PPD Global Standard Operating Procedures. Conducts site management calls on a regular basis to maintain ongoing contact with the sites to assist them with the execution of the registry/compliance programs. Plays an active role within the clinical team to reach project goals, achieve deliverables, and meet project deadlines.
Responsibilities include:
- Communicate with sites to assess facility/staff, implement procedure documents and ensure site compliance with procedure document specifications and regulatory obligations. Make recommendations as warranted. Document communications in phone contact reports. Assist with query resolution as needed
- Identify potential sites/physicians in collaboration with the client company to ensure the acceptability of qualified sites/physicians
- Review regulatory documents and maintain required files at PPD
- Facilitate effective communication between sites, the client company and the PPD project team through written, oral and/or electronic contacts
- Contribute to the project team by mentoring new members, assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members
Qualifications
Education and Experience:
- Bachelor's Degree or an RN certification from an appropriately accredited institution
- 1 year as a clinical monitor or completion of the PPD Drug Development Fellowship
Knowledge, Skills and Abilities:
- Previous successful completion of or ability to successfully complete PPD training program
- Effective clinical site management skills including the ability to interact with physicians and other health care professionals in a knowledgeable and professional manner
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail
- Computer literate and ability to learn appropriate software
- Ability to work in a team environment and independently as needed
- Maintain a working knowledge of Good Clinical Practices and PPD Global Standard Operating Procedures through professional career development
- Serve as a resource for site personnel
PPD is an Equal Opportunity Employer
Additional Information
Position Type: Full Time, Employee
Ref Code: 00549  
| 
