CRA/Senior CRA

Study Planning/set-up activities
·When re******** assist LTM to conduct site feasibility
·conduct Pre-trial visits to assess the investigational staff an********
·Discuss the items liste******** the PAR with the investigatoran******** appropriate staff
·Review the site commitment in detail with the investigator
·Develo******** recruitment an******** strategy for the site
·Ensure all require********-related materials an******** areprovide******** the investigational site
·Ensure that the investigators sen******** SUA gap pack to the IEC/IRB,when the sponsor is not responsible for sending safety information tothe IEC/IRB
·Set up the IF an********
·If nee******** development of site-specific ICF
·Ensure that the investigational staff are instructe******** therequirements for proper informe********
·When local Ethics Committees are used, ensure that the IEC/IRB isprovide******** current an******** copies of all documents that theIEC/IRB requests to fulfill its obligation an******** a copy of theval******** IEC/IRB approval an******** relate******** ********including the composition of the IEC/IRB
·Obtain site relate******** documents an******** them for completenessan********
·Negotiate investigator budgets at site level an******** the status ofsite CTA
·Plan an******** investigator an********-staff training
·Conduct site initiation visits
·If appl******** execute the user acceptance testing plan
·If appl******** create site specific an******** tools

Monitoring activities
·Notify the GTM an******** Local CSC in wr******** when a countryan******** investigational site is approve******** receive clinical drugsupplies
·At the investigational s******** ensure clinical drug supplies areava******** appropriately used, han******** stored (e g , temperaturelogs, security), an********, accurately inventorie******** documented.Inform the investigational staff of the distribution process
·Conduct monitoring visits according to the checklist of activitiesliste******** the Monitoring Visit Report
·Report to LTM on study site status through monitoring report an********
·Document all study relate********
·Perform SDV to ensure accurate data is recorde******** if required
·Follow up with the trial site(s) regarding completion of case reportforms an******** correction forms within require********
·Ensure that all AE******** are reporte******** reporting timelinesan******** as appropriate. For AE******** ensure they are consistentwith all data collecte******** with the information in the sourcedocuments
·Ensure that the investigators sen******** safety reports to theIEC/IRB, when the sponsor is not responsible for sending safetyinformation to the IEC/IRB
·Arrange for the appropriate destruction of clinical drug supplies
·Ensure that the investigational staff stores the randomization codes ina limite******** area that is accessible 24 hours a day an******** themon the code-breaking procedure
·In studies where IVRS/EDC are used, ensure that the IVRS/EDC at thesite work smoothly during the study.
·Track costs at site level an******** payments are made withplanne******** schedule
·Ensure TCF is maintaine******** require******** maintain IF
·Ensure subject commitment per site is met
·Conduct site closure visit according to the checklist activitiesliste******** the site closure report
·If appl******** remin******** investigator to notify the IEC/IRB of thesite closure
·Ensure the IF is complete an********
·Provide study report synopsis to ******** IEC/IRBs
·Check the Site details on Appendix 1 documents an******** feedback tothe LTM
·Follow up on an******** any pending ******** including adverse eventsan******** one year post-trial

General activities
·Represent the company an******** organization adequately to thecustomers an******** external parties
·Base all actions on Credo
·Protect the rights of others, protect privacy an******** assets,particularly information as the key asset
·Conduct business in line with the HCC, company policies an********,including applicable SOPs, always having the ethical aspect in mind
·Maintain adequate communication with relevant parties within an********the company
·Comply with ICH-GCP an******** applicable local laws an********
·Actively follow trainings to ensure adequate qualification forperforming job-relate********
·Report (suspicion of) frau******** scientific/ethical misconduct asappropriate
·Regularly update information in applicable systems an********
·Contribute to the development an******** of departmental proceduresan******** an******** in the scope of the company’s effort towardscontinuous quality improvement
·Maintain quality standards an******** that are consistent with businessneeds