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About the role
- Assistant CRA supporting clinical trials management for top pharmaceutical companies. Performing remote tasks for site management, ensuring compliance with protocols and regulations.
Responsibilities
- Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
- Completes and documents study-specific training.
- Orients and trains on any study-specific systems.
- Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
- Supports to customize Site ICF with site contact details, as needed.
- 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 related qualification process, where applicable.
- Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
- Provides support to follow-up on site staff training, as applicable.
- 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.
- Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
- Supports ongoing remote review of centralized monitoring tools, as directed.
- Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed 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 company 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 CRA and as per Task Matrix.
- May perform a specific role profile for FSP opportunities according to Client requests.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Requirements
- Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
- Basic medical/therapeutic area knowledge and understanding of medical terminology.
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company 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.
- Excellent English and French language and grammar skills.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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