Clinical Research Associate (CRA) Jobs
Columbia, MD
This position performs and coordinates all aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Conducts site visits to determine protocol and regulatory compliance, and prepares required documentation. Represents PPD in the global medical research community and develops collaborative relationships with investigative sites and client company personnel.
Required to travel 60-70% on average.
EDUCATION AND EXPERIENCE:
.Bachelor's degree in life sciences or related field or certification in a related allied health profession from an appropriately accredited institution (i.e.: RN, MT, PA, RPh, RT)
.Minimum two years as a clinical monitor or strong seasoning as a health care professional with an appropriate combination of management experience and/or directly related experience in a specific therapeutic setting that may be substituted for monitoring experience. The combination of experiences appropriate to this level will be determined by current business requirements. (Therapeutic Specialist)
.In some cases, a combination of education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
KNOWLEDGE, SKILLS AND ABILITIES:
.Previous successful completion of or ability to successfully complete PPD training program.
.Effective clinical monitoring skills to include conduction of qualification, initiation, monitoring and close out visits; or health care setting management skills; or core therapeutic expertise
.Excellent understanding of or ability to attain and maintain a working knowledge of GCPs and applicable SOPs
.Basic computer skills and ability to learn and become proficient with appropriate software
.Demonstrated understanding of medical terminology
.Effective oral and written communication skills with ability to communicate effectively with medical personnel
.Strong customer focus and excellent interpersonal skills
.Strong attention to detail
.Proven flexibility and adaptability
.Ability to work in a team environment and independently as needed
.Valid drivers license
.Ability to qualify for and maintain a corporate credit card with sufficient credit line to allow for extensive business travel
For more information please call 910-251-0081
