SR CRA (LEVEL I)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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 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.
.
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.
 Contributes to the project team by assisting in preparation of project  publications/tools, and sharing ideas/suggestions with team members.
Performs  additional study tasks as assigned by CTM (e.
.
trip report review, newsletter  creation, lead CRA team calls etc).
 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.
 Maintains & completes administrative tasks such as expense reports and  timesheets in a timely manner.
 Contributes to other project work and initiatives for process improvement, as  required.