More Information
- Reference number 13/01/2025
- Location In Poland
- The form of work hybrid work
- Working hours full-time
- Experience level required pół roku - 1 rok
- Student status absolwent studiów magisterskich
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Requirements
Position requires approx. 70% travel
At least 6months of relevant monitoring experience (on-site and remote)
Proficient with MS Office Suite
Excellent computer and organizational skills
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Competences sought
High level of attention to detail required
Ability to work on varying projects and exercise critical thinking
Self-starter who can work remotely and a team player who can work cross functionally with some oversight
Knowledgeable in clinical research operations, including interpretation and implementation of country regulations/ICH guidelines, as required per their role as a CRA
Excellent organizational, interpersonal, and communication skills (both verbal and written)
Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment
Knowledgeable in prioritization, problem-solving, organization, critical thinking, decision making, time management, and planning activities
Ability to collaborate with internal and external colleagues and work well in a team-oriented setting
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Scope of duties
Under supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.), independently schedules and conducts remote and on-site monitoring visits such as qualification/pre-study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for-cause visits.
As part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.
Documents observations and monitoring activities in a site visit report at the conclusion of the visit.
Facilitates and oversees Action Item resolution post visit.
Helps to ensure that clinical sites are conducting the study in compliance with protocol/clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.
Provides training and retraining to site staff including protocol, GCP/GDP, and other training under direction from the project CRA staff oversight lead.
Identifies areas requiring follow-up and improvement at each clinical study site and reports findings to project CRA staff oversight lead.
Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures
Serves as point of contact for study site personnel to answer questions and resolve study related issues under the direction of the project CRA staff oversight lead
May assist with the development and/or review of study-related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.
Prepares for and attends project team meetings and provides updates on project status and site-specific performance
Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines
Participates in Investigator Meetings or other client meetings as needed
Assists with filing and archiving of study documents
May assist in preparing sites for audits and may provide support and cooperation during audits/inspections (including translation to Auditor if needed)
May assist with coordination of clinical study supplies
May assist with submission of applications/notifications to Institutional Review Board (IRB)/Ethics Committee (EC)/Regulatory Authority
May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans.
Performs site management activities as required
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Employment conditions offered
Full-time employment
Meal vouchers
Hybrid working
- Number of wanted persons 1
