Junior Accountant

Convoy Finance; Quilmes; On-site; ARS 1,000,000 - 1,400,000; Full time

Job summary

Thermo Fisher Scientific in Buenos Aires seeks an Assistant Clinical Research Associate to support site readiness, monitoring and regulatory compliance across trials globally. You will collaborate with the CRA and Clinical Lead, perform pre-study assessments, assist with site management, remote monitoring, and document control while adhering to SOPs and regulatory guidelines.

Excellent communication and organizational skills required.

Qualifications

• Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent.
• 0–2 years of relevant experience.
• Equivalency may be considered sufficient for the role.

Responsibilities

• Complete study and site management activities as defined in task matrix.
• Complete and document study-specific training.
• Orient and train on any study-specific systems.
• Provide in-house support during pre-study assessments and waivers.
• Support site ICF customization with site contact details.
• Perform remote review of EMR/EHR checklists and support data collection.
• Verify document collection and RCR submission status; update site EDL and verify site information.
• Review patient materials and translations as directed.
• Support vendor qualification processes where applicable.
• Ensure system access for site staff during pre-activation and study.
• Follow up on site staff training as applicable.
• Coordinate and support logistics for IM attendance.
• Maintain vendor trackers as directed.
• Coordinate study/site supply management during pre-activation and subsequent course of the study.
• Support Essential Document collection and updating in systems.
• Follow up on missing vendor data like ECGs, labs, and e-diaries.
• Assist with remote review of centralized monitoring tools.
• Support Site payments processes and reconciliations; follow up on invoices.
• Perform reconciliation tasks on trials including CRF and queries.
• Drive action for missing/incomplete/expired documents.
• May perform other site management tasks as directed.
• May perform a role profile for FSP opportunities per Client requests.
• Maintain and complete administrative tasks such as expense reports and timesheets.

Skills

ICH GCP knowledge

Communication skills

MS Office

English proficiency

Organizational skills

Teamwork

Education

Bachelor's degree in life science

Registered Nursing certification

Tools

CTMS

Job description

Buenos Aires ThermoFisher Scientific

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Assistant Clinical Research Associate - Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you'll have the opportunity to perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate, you'll provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.

What You'll Do

• Completes study and site management activities as defined in task matrix, andas applicable and directed for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
• Provides support to follow-up on site staff training, as applicable.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports maintenance of vendor trackers, as directed.
• Coordinates study/site supply management during pre-activation and subsequentcourse of the study.
• Supports Essential Document collection, review and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
• Performs 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 in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
• May perform other assigned site management tasks, as directed by CRA and as per Task Matrix.
• May perform a specific role profile for FSP opportunities according to Client requests.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience Requirements

• Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
• Effective oral and written communication skills
• Excellent interpersonal and customer service skills
• Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven flexibility and adaptability
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
• Excellent English language and grammar skills

Working Conditions and Environment

• Work is performed most of the time in an office or home office environment.; occasional travel toclinics/hospitals may be required.
• Exposure to electrical office equipment.
• The Assistant CRA role does not involve regular travel, however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.