Assistant CRA

Thermo Fisher Scientific

20h

About The Position

The Assistant Clinical Research Associate supports assigned clinical research projects by performing remote activities in liaison with the CRA and study Clinical Lead. The role supports site preparedness, monitoring logistics, site management, and remote monitoring in accordance with standard operating procedures and regulatory guidelines. Limited site contact may be assigned during study start-up, site management, recruitment, and close-out phases. The position completes study- and site-management tasks according to the project task matrix, supports study-specific training and systems, assists with essential document and site information processes, coordinates study and site supplies and logistics, and helps follow up on data, training, invoices, and missing documents. The role also performs assigned reconciliation and administrative tasks. Work is generally performed in an office or home-office environment, with occasional travel to clinics or hospitals. Regular travel is not part of the Assistant CRA role; advancement to direct CRA opportunities may involve frequent travel of 60–80%.

Requirements

Bachelor’s degree in a life science discipline or related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0–2 years; an appropriate combination of education, training, and/or directly related experience may be considered equivalent.
Basic medical or therapeutic-area knowledge and understanding of medical terminology.
Ability to attain and maintain 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, strong attention to detail, and proven ability to handle multiple tasks efficiently and effectively.
Flexibility and adaptability.
Ability to work in a team or independently, as required.
Well-developed critical thinking skills, including a critical mindset, in-depth investigation for root-cause analysis, and problem solving.
Proficient computer skills, good knowledge of MS Office, and ability to learn and use appropriate software and modern technology.
Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards.
Excellent English language and grammar skills.

Responsibilities

Complete study and site management activities defined in the task matrix, as applicable and directed for assigned studies.
Complete and document study-specific training and orient to study-specific systems.
Provide in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for the project.
Support customization of site informed consent forms with site contact details as needed.
Perform remote review of EMR/EHR checklists and support collection and applicable assessments.
Verify document collection and RCR submission status, update the site EDL, and verify site information.
Review patient-facing materials and translations as directed.
Support site staff with vendor-related qualification processes 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 IM attendance as directed.
Support maintenance of vendor trackers as directed.
Coordinate study and site supply management during pre-activation and throughout the study.
Support collection, review, and updating of essential documents in systems as applicable.
Follow up on missing study vendor data, including ECGs, lab samples, and e-diaries, as directed.
Support ongoing remote review of centralized monitoring tools as directed.
Support site payment processes by coordinating with internal functional departments and sites; support system updates and reconciliations and follow up on site invoices throughout the study.
Perform reconciliation tasks on assigned trials, including CRF and query status, deviations, SAEs, and safety reports, as applicable.
Verify document collection status in company systems and drive action on missing, incomplete, or expired documents and open document findings as directed.
Perform other assigned site management tasks as directed by the CRA and according to the task matrix.
Perform a specific role profile for FSP opportunities according to client requests, if applicable.
Complete administrative tasks, including expense reports and timesheets, in a timely manner.