Assistant CRA

Work Schedule

Environmental Conditions

Job Description

Job Title: Assistant Clinical Research Associate (CRA)

Job Description:The Assistant CRA performs remote activities on assigned projects in coordination with the Remote CRA On-Site CRA and study Clinical Trial Manager (CTM). This role provides support for site preparedness logistical support for the monitoring process and assists with tasks related to site management and remote monitoring in accordance with Standard Operating Procedures (SOPs) and regulatory guidelines. The Assistant CRA may also be assigned limited site contact activities during study start-up site management recruitment and close-out phases.

Essential Functions:

• Complete study and site management activities as defined in the task matrix and as directed for the assigned study.
• Complete and document study-specific training.
• Orient and train on any Clinical Research Group (CRG)/study-specific systems.
• Provide in-house support during pre-study assessments and with pre-study assessment waivers as agreed for the project.
• Customize Site Informed Consent Forms (ICF) with site contact details as needed.
• Perform remote review of Electronic Medical Records (EMR)/Electronic Health Records (EHR) checklists and support collection as applicable.
• Verify document collection and Regulatory Compliance Review (RCR) submission status; update site Essential Document List (EDL) and verify site information.
• Review patient-facing materials and translations as directed.
• Support site staff with the vendor-related qualification process where applicable.
• Ensure system access is requested/granted and revoked for relevant site staff during pre-activation and throughout the study.
• Follow up on site staff training as applicable.
• Coordinate and support logistics for Investigator Meetings (IM) attendance as directed.
• Maintain vendor trackers as directed.
• Coordinate study/site supply management during pre-activation and throughout the study.
• Support Essential Document collection review and updating in systems as applicable.
• Follow up on missing study vendor data like ECGs lab samples and e-diaries as directed.
• Perform ongoing remote review of centralized monitoring tools as directed.
• Support site payment processes by coordinating with various functional departments within the organization and the site. Update systems and perform reconciliations as directed and follow up on site invoices throughout the study period.
• Perform reconciliation tasks on assigned trials including but not limited to Case Report Form (CRF) and query status deviations Serious Adverse Events (SAEs) and safety reports as applicable.
• Verify document collection status in CRG systems and drive action for missing/incomplete/expired documents and open document findings as directed.
• Perform other assigned site management tasks as directed by the Remote CRA and as per the Task Matrix.
• Perform specific role profiles for Functional Service Provider (FSP) opportunities according to client requests.
• Maintain and complete administrative tasks such as expense reports and timesheets in a timely manner.

Qualifications:

Education and Experience:

• Bachelors degree 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 CRG procedural documents.
• Effective oral and written communication skills.
• Excellent interpersonal and customer service skills.
• Good interpersonal and time management skills and strong attention to detail with ability to handle multiple tasks efficiently and effectively.
• Ability to work in a team or independently.
• Well-developed critical thinking skills including but not limited to: critical outlook in-depth investigation for appropriate root cause analysis and problem-solving.
• Proficient computer skills with good knowledge of MS Office and the 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 Clinical Trial Management Systems (CTMS) and dashboards.
• Excellent English language and grammar skills.

Why Thermo Fisher Scientific

We provide a competitive salary and benefits package. You will be a member of a diverse and inclusive team that values collaboration and creativity. Our dedication to your professional growth guarantees that you can progress and excel in your career. Come aboard and a significant impact through innovative research that transforms lives!