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.
