Assistant CRA

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

📋 Description

• Executes study and site management tasks as specified in the task matrix, and as directed for the assigned study.

• Completes and records training specific to the study.

• Provides orientation and training on any systems that are specific to the study.

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

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

• Conducts remote reviews of the EMR/EHR checklist 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 materials intended for patients and evaluates translations, as directed.

• Aids site personnel with 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 training for site staff, as applicable.

• Organizes and coordinates logistics for IM attendance, as directed.

• Assists in maintaining vendor trackers, as needed.

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

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

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

• Assists with 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.

• Carries out reconciliation tasks on assigned trials, which may include 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 carry out other assigned site management tasks as directed by the CRA and according to the Task Matrix.

• May undertake specific role profiles for FSP opportunities based on client requests.

• Maintains and completes administrative duties 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.

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

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

• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations, and company procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal and customer service abilities.

• Good organizational and time management skills with a keen attention to detail.

• Demonstrated flexibility and adaptability.

• Capability to work both in a team environment and independently, as necessary.

• Well-developed critical thinking skills.

• Proficient in computer skills, with good knowledge of MS Office.

• Ability to extract relevant information from all study documents.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.

• Professional development opportunities.