Job Title: Senior Clinical Research Associate

Job Location: Wilmington, NC

Job Description:
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. Performs the function of mentor for junior clinical team members. May assist the Project Manager, Senior Project Manager or CTM with certain project management functions. 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.
•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.
•Excellent clinical trials monitoring skills to include conduction of qualification, initiation, monitoring and close out visits.
•Demonstrated ability to mentor and train other monitors in a positive and effective manner.
•Excellent understanding of FDA guidelines and GCPs and ability to attain and maintain a working knowledge of applicable SOPs.
•Basic computer skills and ability to learn and become proficient with appropriate software
•Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology.
•Effective organizational skills and strong attention to detail.
•Effective oral and written communication skills with ability to communicate effectively with medical personnel
•Excellent team player with team building skills.
•Strong customer focus and excellent interpersonal skills
•Ability to utilize problem-solving techniques applicable to constantly changing environment
•Valid Driver’s License and ability to qualify for and maintain a corporate credit card with sufficient credit line to allow for extensive business travel

PPD IS AN EQUAL OPPORTUNITY EMPLOYER

Person of Contact:
Mark Czesak
Phone: 910-772-2885
Email: mark.czesak@wilm.ppdi.com