Assistant CRA

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

📋 Description

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

• Completes and documents training specific to each study.

• Provides orientation and training on any systems related to the study.

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

• Assists in tailoring the Site Informed Consent Form (ICF) with site contact information, as necessary.

• Conducts remote reviews of EMR/EHR checklists and aids in the collection of 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 directed.

• Aids site staff in the vendor qualification process when applicable.

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

• Follows up on site staff training as needed.

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

• Assists in maintaining vendor trackers as instructed.

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

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

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

• Aids in the ongoing remote review of centralized monitoring tools as requested.

• Facilitates Site payments processes by coordinating with various functional departments within the organization and the site.

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

• Confirms document collection status in company systems and drives actions for any missing, incomplete, or expired documents and open document findings as directed.

• May undertake other assigned site management responsibilities 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 administrative tasks such as expense reports and timesheets punctually.

⛳️ Requirements

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

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

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

• Ability to acquire and retain 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 keen attention to detail, with a proven capacity to manage multiple tasks efficiently and effectively.

• Demonstrated flexibility and adaptability.

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

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

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

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

• Exceptional English language and grammar proficiency.

🏝️ Benefits

• Flexible work arrangements

• Professional development opportunities

• Travel opportunities