Sr CRA (Level II)

Company Name:PPD Development, L.P.Position Title:Senior Clinical Research Associate (Level II)Location:929 North Front Street, Wilmington, NC 28401

Summary of Duties: Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations, and PPD SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Ensures 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. Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records and clinic notes (source document verification). Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously, presents solutions, and follows all issues through to resolution. Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations. Performs additional tasks as assigned by CTM or Clinical Manager of CRAs. 80% domestic travel. Duties may be performed remotely.

Company Name:PPD Development, L.P.Position Title:Senior Clinical Research Associate (Level II)Location:929 North Front Street, Wilmington, NC 28401

Summary of Duties: Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations, and PPD SOPs. Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Ensures 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. Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records and clinic notes (source document verification). Assesses investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously, presents solutions, and follows all issues through to resolution. Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations. Performs additional tasks as assigned by CTM or Clinical Manager of CRAs. 80% domestic travel. Duties may be performed remotely.

Qualifications: Bachelor’s degree in a life science or related field and three (3) years’ experience as Clinical Research Associate or related role. Three (3) years’ experience in: Clinical Trial Management systems; Electronic Data Capture; Microsoft Office; Electronic Medical Record Review; and IVRS/IWRS System Review. Two (2) years’ experience in: Electronic Filing Systems; Review Site and Patient Visualization Tool; and Electronic Training System Proficiency.

Qualifications: Bachelor’s degree in a life science or related field and three (3) years’ experience as Clinical Research Associate or related role. Three (3) years’ experience in: Clinical Trial Management systems; Electronic Data Capture; Microsoft Office; Electronic Medical Record Review; and IVRS/IWRS System Review. Two (2) years’ experience in: Electronic Filing Systems; Review Site and Patient Visualization Tool; and Electronic Training System Proficiency.