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.
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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