Job Description

 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 pplicable 
 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.
 Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CMCRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
 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). Perform QC 
check of reports generated from CTMS system where required.
 Facilitates effective communication between investigative sites, the client 
company and the PPD project team through written, oral and/or electronic 
contacts.
 Responds to company, client and applicable regulatory 
requirements/audits/inspections federal regulatory requirements/audits.
 Maintains & completes administrative tasks such as expense reports and 
timesheets in a timely manner