Assistant CRA

Description

• Completes study and site management activities as defined in task matrix, and as applicable and directed for the assigned studies.
• Completes and documents study-specific training.
• Orients and trains on any CRG/study-specific systems.
• Provides in-house support during pre-study assessments.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor qualification process.
• Ensures that system access is requested, granted or revoked for relevant site staff throughout the study. Oversees site staff training and ensures this is current.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports maintenance of vendor trackers, as directed.
• Coordinates study/site supply management during pre-activation and subsequent course of the study.
• Supports Essential Document collection, review and updating in systems, as applicable.
• Resolves missing vendor data such as ECGs, lab samples, and e-diaries, as directed.
• Conducts ongoing remote review of centralized monitoring tools, as directed.
• Facilitates the site payment processes by coordinating with various functional departments within the organization and with the site.
• Supports system updates and reconciliations and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
• Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
• May perform other assigned site management tasks, as directed by study team and as per Task Matrix.
• May perform a specific role profile for FSP opportunities according to Client requests.
• Maintains & completes administrative tasks such as training, expense reports and timesheets in a timely manner.
• Job Complexity: Works on problems of limited scope.
• Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
• Job Knowledge: Learns to use professional concepts.
• Applies company policies and procedures to resolve routine issues.
• Supervision Received: Normally receives detailed instructions on all work.
• Business Relationships: Contacts are primarily with immediate supervisor, and other personnel in the department.
• Builds stable working relationships internally.

Qualifications

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Basic medical/therapeutic area knowledge and understanding of medical terminology.
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRG procedural documents.
• Effective oral and written communication skills.
• Excellent interpersonal and customer service skills.
• Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
• Proven flexibility and adaptability.
• Ability to work in a team or independently, as required.
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software.
• Leverage modern technology when applicable.
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards.