PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
Requisition ID: 154480
The Senior Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures.
Key Responsibilities Include
- Conducts site visits to assess protocol and regulatory compliance and manages required documentation
- Responsible for ensuring that data will pass international quality assurance audits.
- Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigation sites and client company personnel.
- May assist project manager or clinical team manager on assigned projects.
- Travel across Africa, but in particular Kenya, Tanzania, Uganda & Ethiopia
Education And Experience
- Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution
- Previous experience as a clinical research monitor (comparable to 3+ years) that provides the required knowledge, skills and abilities
- Valid Driver's License where applicable
- In some cases an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
Knowledge, Skills and Abilities:
- Effective clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Strong customer focus
- Effective interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Proven flexibility and adaptability
- Ability to work in a team or independently as required
- Good computer skills: good knowledge of Microsoft Office
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Method of Application
Interested and qualified? Go to PPD career website on ppdi.referrals.selectminds.com to apply