Provides project-specific clerical support to the Clinic Research Managers (CRM) and Primary Study Investigator during the course of a clinical research study. Maintains the clinical research essential files. Facilitates the submission of documents to the IRB's during study initiation activities. Distributes study related documents as needed. Audits study files to ensure all project documents are accounted for and no incorrectly filed documents exist in the file. Performs other duties as assigned. Work is performed in office.
Education
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate.
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). 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, Abilities
Ability to work in a team or independently as required
Good organizational skills and strong attention to detail, with ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
Strong customer focus
Flexibility to prioritize workload to meet changing project timelines
Ability to attain and maintain a good working knowledge of applicable regulations and procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout
Good English language and grammar skills
Good computer skills, proficient in MS Office, ability to obtain knowledge and master all database systems and modern technology
Critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Skills to work under constant pressure to meet project/client deliverables and timelines
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Production, Supply Chain, and Manufacturing
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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