Clinical Research Associate / Site Manager
Jobbeschreibung
Wien, Wien, Österreich
Johnson & Johnson
06.05.2024
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DescriptionA Site Manager (SM) serves as the primary contact point
between the Sponsor and the Investigational Site.A Site Manager is
assigned to trial sites to ensure inspection readiness through
compliance with the clinical trial protocol, company Standard
Operating Procedures (SOP), Good Clinical Practice (GCP), and
applicable regulations and guidelines from study start-up through to
site closure. Responsibilities may include assisting with site
selection, pre-trial assessment, subject recruitment and retention
planning, site initiation, on-siteand remote monitoring and close-out
activities.The Site Manager will partner with the Local Trial Manager
(LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM)
to ensure overall site management while performing trial related
activities for assigned protocols. May contribute to process
improvement andtraining.1. Acts as primary local company contact for
assigned sites for specific trials.2. May participate in site
feasibility and/or pre-trial site assessment visits3.
Attends/participates in investigator meetings as needed.4. Responsible
for executing activities within site initiation and start-up,
preparation and conduct of sitemonitoring (including remote
monitoring), site management (by study specific systems and
otherreports/dashboards) and site/study close-out according to SOPs,
Work Instructions (WIs) and policies.Responsible for the
implementation of analytical risk based monitoring model at the site
level and towork with site to ensure timely resolution of issues found
during monitoring visits.5. Ensures site staff are trained and the
corresponding training records are complete and accurate at anytime
point during all trial phases. Responsible in close collaboration with
LTM and central study teamfor the activities during site activation
phase in order to speed up the process and activate the site
inshortest possible timeframe.6. Contributes to site level recruitment
strategy and contingency planning and implementation inpartnership
with other functional areas.7. Ensures site study supplies (such as
Non-Investigational Product (IP), lab kits, etc.) are adequate
fortrial conduct.8. Ensures that clinical drug supplies are
appropriately used, handled and stored and returns areaccurately
inventoried and documented. 9. Arranges for the appropriate
destruction of clinical supplies.10. Ensures site staff complete data
entry and resolve queries within expected timelines.11. Ensures
accuracy, validity and completeness of data collected at trial
sites12. Ensures that all Adverse Events (AE) /Serious Adverse Events
(SAEs )/Product Quality Complaints(PQCs) are reported within the
required reporting timelines and documented as appropriate.
ForAEs/SAEs, ensures that they are consistent with all data collected
and with the information in thesource documents.13. Maintains
complete, accurate and timely data and essential documents in relevant
systems utilizedfor trial management.14. Fully documents trial related
activities, in particular monitoring. Writes visit reports and
follow-upletter in accordance with the SOPs. Promptly communicates
relevant status information and issuesto appropriate stakeholders.15.
Reviews study files for completeness and ensures archiving retention
requirements are met, includingstorage in a secure area at all
times.16. Collaborates with LTM for documenting and communicating
site/study progress and issues to trialcentral team.17. Attends
regularly scheduled team meetings and trainings.18. Complies with
relevant training requirements. Act as local expert in assigned
protocols. Developstherapeutic knowledge sufficient to support role
and responsibilities.19. Works closely with LTM to ensure Corrective
Action Preventative Action (CAPA) is completed forQuality Assurance
(QA) site audits and for quality issues identified at the site during
routinemonitoring and other visit types, e.g. On Site Quality
Monitoring Visit (OSQMV).20. Prepares trial sites for close out,
conduct final close out visit.21. Tracks costs at site level and
ensure payments are made, if applicable.22. Establishes and maintains
good working relationships with internal and external stakeholders
inparticular investigators, trial coordinators and other site
staff.23. May participate in the Health Authority (HA) and IEC/IRB
submission and notification processes asrequired/appropriate.24. Acts
as a point of contact in site management practices.25. May contribute
to process improvement and training.QualificationsA minimum of a BA or
BS degree in Life Sciences, Nursing or related scientific field (or
equivalent experience) is required.A minimum of 1 year of clinical
trial monitoring experience is preferred, however, other relevant
experiences and skills may be considered by the hiring manager when
considering the candidate’s eligibility.Specific therapeutic area
experience may be required depending on the position.Strong working
knowledge of GCP, company SOPs, local laws and regulations, assigned
protocols and associated protocol specific procedures including
monitoring guidelines.Strong IT skills in appropriate software and
company systems. Willingness to travel with occasional overnight stay
away from home.Proficient in speaking and writing the country language
and English. Good written and oral communication.Job Field:
Clinical/Medical OperationsOrganization: Janssen Cilag Pharma GmbH
(8558)
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Clinical Research Associate / Site Manager
Johnson & Johnson
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