Responsibilities
- 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 studyrelated issues under the direction of the project CRA staff oversight lead. CORPORATE CONFIDENTIAL
- 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
- Assists 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
Qualifications
- Bachelor’s degree (scientific discipline preferred) or equivalent work experience
- At least 1-2 years of relevant monitoring experience (on-site and remote)
- Proficient with MS Office Suite
- Excellent computer and organizational skills
- 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 oral 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