Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Assistant Clinical Research Associate

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeFranceNo salary listed

About the Job

Requirements

A Bachelor's degree in a life science-related field, or a relevant/equivalent formal academic or vocational qualification; an appropriate combination of education, training and/or directly related experience may also satisfy the requirement in some cases.
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.
Interpersonal and customer service skills.
Organizational and time-management skills, attention to detail, and a track record of handling multiple tasks efficiently.
Flexibility and adaptability.
Ability to work in a team or independently, as required.
Critical thinking, investigation, root cause analysis, and problem-solving skills.
Computer skills, knowledge of Microsoft 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 as defined in the task matrix and as directed for assigned studies.
Complete and document study-specific training.
Learn and use company- and 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 with site contact details, as needed.
Perform remote review of electronic medical record/electronic health record checklists and support collection and applicable assessments.
Verify document collection and regulatory country requirement submission status; update the site essential document list and verify site information.
Review patient-facing materials and translations, as directed.
Support site staff through 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 meeting attendance, as directed.
Maintain vendor trackers, as directed.
Coordinate study and site supply management during pre-activation and throughout the study.
Collect, review, and update essential documents in systems, as applicable.
Follow up on missing study-vendor data, including electrocardiograms, laboratory samples, and electronic diaries, as directed.
Support ongoing remote review of centralized monitoring tools, as directed.
Support site payment processes by coordinating with organizational functional departments and the site; support system updates and reconciliations, and follow up on site invoices throughout the study.
Perform reconciliation tasks on assigned trials, including case report form and query status, deviations, serious adverse events, and safety reports, as applicable.
Verify document collection status in company systems and drive action to resolve missing, incomplete, or expired documents and open document findings, as directed.
Perform other assigned site-management tasks as directed by the Remote CRA and in accordance with the task matrix.
Perform a specific role profile for functional service provider opportunities according to client requests, where applicable.
Complete administrative tasks such as expense reports and timesheets in a timely manner.

Desired Qualifications

Clinical research experience would be an advantage.

Work Schedule

Other

Environmental Conditions

Office

Job Description

Assistant CRA – Paris, Lyon & Nantes, FR

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our clinical department defines, develops and delivers clinical programmes. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.

Discover Impactful Work:

As an Assistant CRA (ACRA), you combine knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions, and deliver results.

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.

A Day in the Life:

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 company/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
Support with 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
Follow 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 RCRA 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.

Education

Bachelor’s Degree in a life science-related field or relevant/equivalent formal academic/vocational qualification
Clinical research experience would be an advantage
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

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 leadership skills and strong attention to detail, with a proven track record to handle multiple tasks efficiently and optimally
Proven flexibility and adaptability
Strong attention to detail
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

*Please submit your CV in English

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

About the Company

Thermo Fisher Scientific

Makes lab instruments, reagents and supplies

Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.

Company size: 10,001+
Company stage: IPO
Headquarters: Waltham, MA
Founded: 1956

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