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Company Name:                                              PPD Development, L.P.

Position Title:                                                   Sr. Clinical Research Associate

Location:                                                           929 North Front Street, Wilmington, NC 28401

Summary of Duties: Monitors investigator sites with a risk-based monitoring approach, applies 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. Ensures 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. 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. May need to maintain 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. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM). Participates in investigator meetings as necessary. 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, making recommendations where warranted. Ensures trial close out and retrieval of trial materials. Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share potential solutions for improvements. Duties may be performed remotely. Travel required 60%-80%.

Qualifications: Bachelor’s degree in Biology, Science, Chemistry or related field and Three (3) years of experience in the job offered or as a Clinical Research Associate II, Clinical Research Associate I, Remote Site Monitor or related role. Must have three (3) years of experience with: clinical monitoring; FDA guidelines, ICH GCPs, applicable regulations and procedural documents; risk-based monitoring concepts and processes; use of various clinical systems such as EDC and CTMS systems; Root Cause analysis, critical thinking and corrective and preventative action planning; monitoring visit reporting; and site management and communication, retraining of site staff on protocol as needed.

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