PPD’s Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
The Sr. Clinical Research Associate (CRA) ensures the highest quality review of data and effective interaction with study sites. They conduct on-site monitoring visits throughout the study to help our client deliver life-changing therapies to patients. The Sr. CRA also 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.
- 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 investigational sites and client company personnel
- May assist project manager or clinical team managers on assigned projects
Grow within the CRA career path to Sr CRA II or PCRA or develop into a line manager role. CRAs often transition to our client dedicated teams and to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.
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What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
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 2+ 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 and knowledge of Microsoft Office with the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Below Is Listed The Working Environment/requirements For This Role
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary for typical working hours
- Able to work in non-traditional work environments
- Able to use and learn standard office equipment and technology with proficiency
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
- This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.