Sr. CRA – REGIONAL – CENTRAL US Job in Detroit 48205, Michigan US
The Sr. 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.
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 manager on assigned projects.
Required to travel 60-80% on average.
Education and Experience: Bachelor’s degree in a science related field or an RN certification (or equivalent certification/licensure from an appropriately accredited institution) Previous experience as a clinical research field monitor (comparable to 2+ years) that provides the required knowledge, skills and abilities Valid Driver’s License 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 the ability to learn appropriate software Good English language and grammar skills Good presentation skillsPPD is an Equal Opportunity Employer
Sr. CRA – REGIONAL – CENTRAL US Job in Detroit 48205, Michigan US
Tags: ability, Clinical, clinical research associate, Detroit, Effective, equal opportunity employer, experience, Good, good clinical practices, international quality assurance, knowledge, Michigan, quality assurance audits, research, time management skills, US, written communication skills