Assistant CRA

This is a fully remote position, open to applicants in Singapore.

📋 Description

• Executes study and site management tasks as outlined in the task matrix, and as applicable and instructed for the assigned study.

• Completes and records training specific to the study.

• Provides orientation and training on any study-specific systems.

• Offers in-house support during pre-study assessments and for pre-study assessment waivers, as agreed for the project.

• Assists in customizing the Site ICF with the site's contact details, as necessary.

• Conducts remote reviews of the EMR/EHR checklist and aids in the collection, as applicable assessments.

• Confirms the status of document collection and RCR submissions; updates the site EDL and verifies site information.

• Reviews patient-facing materials and translations, as instructed.

• Aids site staff in the vendor qualification process, where applicable.

• Ensures that system access is requested, granted, and revoked for relevant site staff during pre-activation and throughout the study.

• Follows up on site staff training, as applicable.

• Coordinates and supports logistics for IM attendance, as directed.

• Assists with the maintenance of vendor trackers, as directed.

• Manages study/site supply logistics during pre-activation and throughout the study.

• Supports the collection, review, and updating of Essential Documents in systems, as applicable.

• Follows up on missing study vendor data such as ECGs, lab samples, and e-diaries, as instructed.

• Aids in ongoing remote reviews of centralized monitoring tools, as directed.

• Facilitates site payment processes by coordinating with various functional departments within the organization and the site, supports system updates and reconciliations as directed, and follows up on site invoices throughout the study duration.

• Conducts reconciliation tasks on assigned trials including, but not limited to, CRF and query status, deviations, SAEs, and safety reports, as applicable.

• Verifies the status of document collection in company systems and initiates action for missing, incomplete, or expired documents and open document findings, as instructed.

• May undertake other assigned site management tasks as directed by the CRA and according to the Task Matrix.

• May fulfill a specific role profile for FSP opportunities based on Client requests.

• Completes and manages administrative tasks such as expense reports and timesheets promptly.

⛳️ Requirements

• Bachelor's degree in a life science discipline or related field, or a Registered Nursing certification or equivalent.

• Prior experience that equips the candidate with the knowledge, skills, and abilities required for the position (equivalent to 0 to 2 years).

• Basic understanding of medical/therapeutic areas and medical terminology.

• Capability to acquire and maintain a working knowledge of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal and customer service abilities.

• Good organizational and time management skills, along with a strong attention to detail, demonstrating the ability to manage multiple tasks efficiently and effectively.

• Proven adaptability and flexibility.

• Ability to work collaboratively in a team or independently, as needed.

• Well-developed critical thinking skills, including a critical mindset, thorough investigation for accurate root cause analysis and problem-solving.

• Proficient computer skills with a solid understanding of MS Office.

🏝️ Benefits

• Paid time off.

• Flexible working hours.

• Opportunities for professional development.