Principal CRA

Company Name:PPD Development, L.P.Position Title:Principal Clinical Research AssociateLocation:929 North Front Street, Wilmington, NC 28401

Summary of Duties: Acts as a clinical data management professional to perform and coordinate 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. Assists project manager or clinical team manager on assigned projects and will take a lead role where required. Supports the line manager to mentor, train and contribute to the development of junior clinical team members. Monitors investigator sites, with particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess 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, and follow 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, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. 80% domestic travel requried. Duties may be performed remotely.

Company Name:PPD Development, L.P.Position Title:Principal Clinical Research AssociateLocation:929 North Front Street, Wilmington, NC 28401

Summary of Duties: Acts as a clinical data management professional to perform and coordinate 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. Assists project manager or clinical team manager on assigned projects and will take a lead role where required. Supports the line manager to mentor, train and contribute to the development of junior clinical team members. Monitors investigator sites, with particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entries in relation to patient records/clinic notes (source document verification). Assess 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, and follow 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, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. 80% domestic travel requried. Duties may be performed remotely.

Qualifications: Bachelor's in a Life Science, Medicine, or related field and five (5) years’ experience in a Clinical Research Associate or related role. Two (2) years’ experience with: Application of GCPs and applicable SOPs; FDA Guidelines; Microsoft Office; Medical Terminology; Metrics and Trend Analysis; Root Cause and Risk Based Monitoring; and Evaluating Medical Research Data.

Qualifications: Bachelor's in a Life Science, Medicine, or related field and five (5) years’ experience in a Clinical Research Associate or related role. Two (2) years’ experience with: Application of GCPs and applicable SOPs; FDA Guidelines; Microsoft Office; Medical Terminology; Metrics and Trend Analysis; Root Cause and Risk Based Monitoring; and Evaluating Medical Research Data.