Assistant CRA - FSP

Thermo Fisher Scientific

About The Position

The Assistant Clinical Research Associate provides support for site preparedness, monitoring logistics, site management, and remote monitoring in accordance with standard operating procedures and regulatory guidelines. The role performs remote activities on assigned projects in liaison with the CRA and study Clinical Lead, and may have limited site contact during study start-up, site management, recruitment, and close-out. The role may also follow a specific FSP role profile according to client requests. The position supports study and site management activities, study-specific training and systems, pre-study assessments, site documentation and information, vendor qualification, site staff access and training, meeting and supply logistics, essential document management, follow-up on missing vendor data, centralized monitoring tools, site payments and invoices, and trial reconciliation tasks. Administrative duties include timely completion of expense reports and timesheets. Work is performed most of the time in an office or home office environment. Occasional travel to clinics or hospitals may be required. The Assistant CRA role does not involve regular travel; direct promotional opportunities in the CRA career track require frequent travel of 60–80%.

Requirements

Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent and relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0–2 years; an equivalent combination of appropriate education, training, and/or directly related experience may be considered.
Previous experience in oncology clinical studies is required, preferably in roles such as CTC, PSC, or Study Coordinator.
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 leverage modern technology when applicable.
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 as defined in the task matrix and as directed for assigned studies.
Complete and document study-specific training and learn study-specific systems.
Provide in-house support during pre-study assessments and 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 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.
Support 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, such as 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 relevant internal departments and the site; support system updates and reconciliations and follow up on site invoices throughout the study.
Perform assigned trial reconciliation tasks, 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.
Complete administrative tasks, including expense reports and timesheets, in a timely manner.