Prin CRA

Job Description

 Monitors investigator sites with particular ability to manage complex studies and/or challenging sites using 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 pplicable  Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).  Supports Clinical Team Management, including or Clinical Manager of CRAs (CMCRA), to mentor, train and contribute to the development of junior CRAs. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate. Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts

Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required. 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. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner