FSP-CRA (Customer- dedicated) with Sign on bonus!
: Job Details :

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAccountable for all aspects of site management including ensuring completion and delivery of all local activitiesrequiredfor high quality set up, execution and completion of studies to agreed timelines.Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency (Risk Based Monitoring) and site closeout visits.Collaborates with the study teams to conduct study feasibility and site selection. Performs site evaluation visits,determinesthe feasibility of conducting protocols with reference to study complexity, staff availability, clinical facilities, potential for recruiting patients, site selection and ability tocomply withICH GCP investigator and GSK requirements for clinical studies.Works with Local Delivery Lead (LDL) to carry out a local study / site level risk assessment.Assistswith audits and inspections.Communicates progress and relevant study information or escalate issues of the study to the local study management team and other key stakeholders-e.g.CRA Manager / Lead asappropriate.Ensures that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met.Maintains good relationships with site while communicating and implementing patient inclusion / exclusion criteria, study stop/go decisions, timeline changes, early termination of studies and changed status of studies.Works with the sites to ensure they address data queriesin a timely manner. Ensure Investigator and site staff receive safety reports and new safety informationin a timely manner.Assists (depending on local practices) with submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs) andmaintaincommunication with RA and ECs to ensure all regulatory requirements are met intimelymanner throughout the study.Ensures all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study.Ensure all unused study supplies are accounted for and destroyed appropriately.Ensures clinical study activities are conductedin accordance withthe clinical trial agreement and related contracts.Responsible formaintainingthe sponsor files during the life of the study.Assistingwith archiving at the end of studyin accordance withrelevant GSK SOPs,policiesand local regulatory requirements.Deliversappropriate trainingto site staff and other relevant parties, asrequired.Accountable toacquireandmaintainan optimallevel of knowledge in all areas to effectively perform study activities. May take on role of local expert/champion or subject matter expert in a business system / process.Shares best practices within the LOC and with colleagues in other LOCs.Acquiresandmaintainsan appropriate levelof knowledge on the pathology of disease area being studied, the study compound, the studyprotocoland all study related activities.Attendanceatinternal project meetings and relevant training courses. Participates continuously in relevant training courses to improve personal / professional skills. Keeps up to date with all the changes / required knowledge on ICH GCP, GSK written standards and attendingappropriate trainingsessions.Available and willing to travel as job requires.