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Assistant CRA

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Thermo Fisher Scientific

18d ago

  • Job
    Full-time
    Entry & Junior Level
  • Research & Development
    Healthcare
  • Birmingham, +25
    Remote

AI generated summary

  • You need a life science degree or nursing certification, 0-2 years of related experience, good communication skills, attention to detail, flexibility, critical thinking, and proficiency in MS Office.
  • You will manage study tasks, verify documents, support site training, coordinate logistics, and assist with data collection and site payments throughout the study lifecycle.

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).
  • 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

Responsibilities

  • Completes study and site management activities as defined in task matrix, and as 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 subsequent course 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.

FAQs

What is the work schedule for the Assistant CRA position?

The work schedule for the Assistant CRA position is standard, Monday through Friday.

What are the primary responsibilities of an Assistant Clinical Research Associate?

The primary responsibilities include completing study and site management activities, providing logistical support, assisting with site training, verifying document collection, and coordinating site supply management.

Is prior experience required for this role?

Yes, the role requires previous experience that provides the knowledge, skills, and abilities to perform the job, typically comparable to 0 to 2 years.

What educational qualifications are needed to apply for the Assistant CRA position?

A Bachelor's degree in a life science discipline, a Registered Nursing certification, or equivalent formal academic/vocational qualification is required.

Will there be any travel involved in this position?

The Assistant CRA role does not involve regular travel; however, occasional travel to clinics/hospitals may be required.

What knowledge is beneficial for an Assistant CRA?

A basic understanding of medical terminology, ICH GCP, applicable regulations, and company procedural documents is beneficial.

What skills are important for an Assistant CRA?

Important skills include effective communication, organizational and time management skills, attention to detail, flexibility, critical thinking, and proficiency in MS Office.

What working environment can the Assistant CRA expect?

The work environment is primarily an office or home office setting, with occasional exposure to electrical office equipment.

Are there opportunities for career advancement in this role?

Yes, while the Assistant CRA position itself involves limited travel, direct promotional opportunities in the CRA career track will require frequent travel (60-80%).

How is performance managed in this role?

Performance is managed through the execution of assigned tasks, completion of administrative duties, and regular communication with the Clinical Research Associate and study Clinical Lead.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.