Assistant CRA

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

📋 Description

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

• Completes and records training specific to the study.

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

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

• Assists in customizing the Site ICF with relevant site contact information, as necessary.

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

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

• Reviews patient-facing materials and assesses translations, as directed.

• Aids site personnel with the vendor qualification process, as necessary.

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

• Supports follow-up on site staff training, as applicable.

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

• Aids in the upkeep of vendor trackers, as instructed.

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

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

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

• Supports ongoing remote assessments of centralized monitoring tools, as directed.

• Facilitates site payment processes by collaborating with various functional departments within the organization and at the site. Aids in 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 document collection status within company systems and drives action for any missing, incomplete, or expired documents and addresses open document findings, as directed.

• May undertake additional site management tasks as directed by the CRA and per the Task Matrix.

• May fulfill a specific role profile for FSP opportunities according to client requests.

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

⛳️ Requirements

• Bachelor’s degree in a life science discipline or a related field, or a Registered Nursing certification or equivalent formal academic/vocational qualification.

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

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

• Ability to acquire and maintain a thorough understanding of ICH GCP, relevant regulations, and company procedural documents.

• Strong oral and written communication skills.

• Exceptional interpersonal and customer service abilities.

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

• Established flexibility and adaptability.

• Capability to work collaboratively within a team or independently, as needed.

• Well-developed critical thinking skills, encompassing a critical mindset, thorough investigation for appropriate root cause analysis and problem resolution.

• Proficient computer skills with a solid understanding of MS Office and the ability to learn and utilize relevant software. Leverage modern technology where applicable.

• Ability to extract relevant information from all study documents, electronic study data systems, CTMS, and dashboards.

• Excellent command of the English language and grammar skills.

🏝️ Benefits

• Flexible work arrangements

• Professional development opportunities