Sr CRA
hace 3 días
Job Description
 Monitors investigator sites with a risk-based monitoring approach, applies rootÂ
cause analysis (RCA), critical thinking and problem-solving skills to identify siteÂ
processes failure and corrective/preventive actions to bring the site intoÂ
compliance and decrease risks. Ensures data accuracy through SDR, SDV andÂ
CRF review as applicable through on-site and remote monitoring activities.Â
Assess investigational product through physical inventory and records review.Â
Documents observations in reports and letters in a timely manner usingÂ
approved business writing standards. Escalates observed deficiencies and issuesÂ
to clinical management expeditiously and follow all issues through to resolution.Â
May need to maintain regular contact between monitoring visits withÂ
investigative sites to confirm that the protocol is being followed, that previouslyÂ
identified issues are being resolved and that the data is being recorded in aÂ
timely manner. Conducts monitoring tasks in accordance with the approvedÂ
monitoring plan. Participates in the investigator payment process. Ensures aÂ
shared responsibility with other project team members on issues/findingsÂ
resolution. Investigates and follows-up on findings as pplicableÂ
ï· Provides updates on potential trends noted across multiple sites and discussesÂ
potential strategies for their management to the Clinical Team Manager (CTM).Â
ï· Participates in investigator meetings as necessary. Identifies potentialÂ
investigators in collaboration with the client company to ensure the acceptabilityÂ
of qualified investigative sites. Initiates clinical trial sites according to theÂ
relevant procedures to ensure compliance with the protocol and regulatory andÂ
ICH GCP obligations, making recommendations where warranted. Ensures trialÂ
close out and retrieval of trial materials.
ï· Ensures that required essential documents are complete and in place, accordingÂ
to ICH-GCP and applicable regulations. Conducts on-site file reviews as perÂ
project specifications.Â
ï· Contributes to the project team by mentoring new members, assisting inÂ
preparation of project publications/tools including informed consents, CRFÂ
guidelines and monitoring plans, and sharing ideas/suggestions with teamÂ
members. Assists in project specific training for the clinical team whereÂ
necessary. Identifies areas for potential process improvements & share potentialÂ
solutions for improvements.
ï· 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).
ï· Provides trial status tracking and progress update reports to the Clinical TeamÂ
Manager (CTM) as required. Ensures study systems are updated per agreedÂ
study conventions (e.g. Clinical Trial Management System, CTMS). Perform QCÂ
check of reports generated from CTMS system where required.
ï· Facilitates effective communication between investigative sites, the clientÂ
company and the PPD project team through written, oral and/or electronicÂ
contacts.
ï· Responds to company, client and applicable regulatoryÂ
requirements/audits/inspections federal regulatory requirements/audits.
ï· Maintains & completes administrative tasks such as expense reports andÂ
timesheets in a timely manner
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