PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
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 Clinical Research Associate II (CRA) / Sr 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
Growwithin the CRA career path to Sr CRA II or PCRA or develop into a line managerrole. CRAs often transition to our client dedicated teams and to becoming CTMsworking alongside our Project Management team responsible for clinicaldeliverables on our studies.
At PPD wehire the best, develop ourselves and each other, and recognize the power ofbeing one team. It's not just talk - our award winning training programs speakfor themselves.
To learn how PPD can advance your career, apply now!
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.
Qualifications 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 minimum 2 years in interventional trials 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
PPD values thehealth and wellbeing of our employees. We support and encourage individuals tocreate a healthy and balanced environment where they can thrive.
Below is listed the workingenvironment / requirements for this role :
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.