Assistant CRA

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

📋 Description

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

• Completes and records training specific to the study.

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

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

• Aids in customizing the Site Informed Consent Form (ICF) with contact details as necessary.

• Conducts remote reviews of the EMR/EHR checklist and supports collection for assessments as applicable.

• Assists site staff with the vendor qualification process, when relevant.

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

• Provides follow-up support on site staff training, as required.

• Coordinates and facilitates logistics for Investigator Meetings (IM), as directed.

• Aids in maintaining vendor trackers as instructed.

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

• Assists with 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 directed.

• Supports ongoing remote reviews of centralized monitoring tools, as instructed.

• Coordinates site payment processes by liaising 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 period.

• Carries out reconciliation tasks for 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 issues, as directed.

• May undertake other designated site management responsibilities as directed by the Clinical Research Associate (CRA) and as per the Task Matrix.

• Completes administrative duties such as expense reports and timesheets in a timely manner.

⛳️ Requirements

• 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 individual with the knowledge, skills, and abilities necessary to perform the job (equivalent to 0 to 2 years).

• Basic understanding of the medical/therapeutic area and familiarity with medical terminology.

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

• Strong oral and written communication abilities.

• Excellent interpersonal and customer service skills.

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

• Demonstrated flexibility and adaptability.

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

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

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

• Competence in extracting relevant information from all study documents, electronic study data systems, CTMS, and dashboards.

• Exceptional English language and grammar skills.

🏝️ Benefits

• Opportunities for professional development.

• Options for remote work.