CRA accountabilities include:• feasibility, site qualification, contracting and preparing documentation for necessaryapprovals, initiating sites, performing routine monitoring visits & closeout visits accordingto all SOP/GCP/legal requirements• obtaining and preparing documents required by RA and EC submissions, includingamendments, notifications and end-of-trial notification• setting up of finance systems accurately, processing invoices & tracking payments• processing SUSAR notifications and SAEs in a timely manner• reviewing CRFs (paper or electronic) and subject source documentation for validity andaccuracy and generate queries to sitesSnCTA responsibilities include:• assisting CRAs on monitoring visits including pre-study, initiation, monitoring, close-outincluding arrangement, organization and supporting of these visits• arranging translation of patient documents, managing and maintaining studydocuments & trial supplies e.g.: Patient Information Sheets, Patient Diaries• co-operation and correspondence with Sponsor representatives• assisting with collating, tracking & shipping CRFs & data queries to Data Management,• general study filing into TMF/eTMF (Veeva Vault)• coordinating archiving of study documentation• preparing study for MHRA inspection• taking minutes & distributing• sending out Study Newsletters/Study Correspondence to all participating sitesTherapeutic areas: Rare Diseases, Urology, Infectious diseases, Dermatology, Rheumatology,Neurology

CTA responsibilitites include:• tracking, reporting of negotiating, contract development, approval, maintenancepayments, entire administrative aspects of clinical trials including start-ups• quality and control of TMF/eTMF(Veeva Vault)• preparing essential clinical trial documentation, distributing, tracking and filing ofdocuments on return• ensuring that any clinical trial databases/tracking tools are set up and maintainedthroughout the trial• conducting feasibility studies in various indications field of medicine• preparing study for external and internal audits performed by sponsor and QA DirectorSafety Officer duties include:• reporting promptly and in accordance with sponsor SOPs and ICH-GCP and localregulatory requirements any SAEs reported by sites to relevant sponsor contact and/orRegulatory Authority contact as appropriate• distributing of safety reports (SUSARs, Line Listings, DSURs) in accordance with IEC & localregulatory requirements to the sites, Regulatory Authorities, Ethic Committees• collection of initial and follow up SAE reports & checking of SAE reports for accuracy,consistency, completeness, and English translation of supporting documents• forwarding SAE reports to the Sponsor & forwarding any queries raised to theinvestigator site• managing data related with the safety reportsTherapeutic areas: Urology, Infectious diseases, Dermatology, Rheumatology, Neurology,Oncology