Company Name: PPD Development, L.P.
Position Title: Principal Clinical Research Associate (Multiple Positions Available)
Location: 929 North Front Street, Wilmington, NC 28401

Summary of Duties: Perform and coordinate all aspects of the clinical monitoring and site management process. Conduct remote or on- site visits to assess protocol and regulatory compliance and manage required documentation. Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects’ rights, well-being and data reliability. Ensure audit readiness. Develop collaborative relationships with investigational sites and client company personnel. Assist project manager or clinical team manager on assigned projects and will take a lead role where required. Support the line manager to mentor, train and contribute to the development of junior clinical team members. Monitor investigator sites with particular ability to manage complex studies and/or challenging sites using a risk-based monitoring approach, apply root cause analysis (RCA), critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Document observations in reports and letters in a timely manner using approved business writing standards. Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. Conduct monitoring tasks in accordance with the approved monitoring plan. Participate in the investigator payment process. Ensure a shared responsibility with other project team members on issues/findings resolution. Investigate and follows-u on findings as applicable. Provide updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Support Clinical Team Management, including or Clinical Manager of CRAs (CM-CRA), to mentor, train and contribute to the development of junior CRAs. Assist in project specific training for the clinical team where necessary. Identify areas for potential process improvements, share potential solutions and implement where appropriate. Facilitate effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contact. Duties may be performed remotely. 80% domestic travel.

Qualifications: Bachelor’s degree in Chemistry, Pharmaceutical Science, Medical Science, or other life science related field, and five (5) years of experience as a Clinical Research Associate, Clinical Research Coordinator, Clinical Trial Coordinator, Laboratory Assistant, or other related role. Employer will also accept a Master’s degree in Chemistry, Pharmaceutical Science, Medical Science, or other life science related field, and three (3) years of experience as a Clinical Research Associate, Clinical Research Coordinator, Clinical Trial Coordinator, Laboratory Assistant, or other related role. Three (3) years of experience with: Clinical monitoring; Application of FDA guidelines, ICH GCPs regulations, and SOPs; In-depth investigation for appropriate root cause analysis and problem solving; Risk Based Monitoring concepts and processes; Evaluating medical research data and knowledge of medical terminology; Veeva Vault Clinical (CTMS, eTMF, SDE, EDC, SSU); EMR; Monitoring Visit Report writing; and Source Document Review/Source Document Verification. Two (2) years of experience with: Mentoring and training others.