Assistant CRA

Work Schedule

Environmental Conditions

Job Description

ACRA United Kingdom

PPD part of Thermo Fisher Scientific are currently hiring for experienced Assistant Clinical Research Associates across the UK.

At Thermo Fisher Scientific youll 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 lifechanging 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 endtoend 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 highquality costefficient clinical studies.

PPD Clinical Research Services are currently hiring for ACRAs to join our team in the UK across a range of locations.

The ACRA:

Performs remote activities on assigned projects in liaison with the Remote CRA OnSite 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 startup 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 studyspecific training.
• Orients and trains on any CRG/studyspecific systems.
• Provides inhouse support during prestudy assessments and with prestudy asssessment 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 preactivation and subsequent course of the study.
• Provides support to followup on site staff training as appplicable.
• Coordinates and supports logistics for IM attendance as directed.
• Supports maintenance of vendor trackers as directed.
• Coordinates study/site supply management during preactivation 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 ediaries 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 followsup 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 CRG systems and drives action for missing/incomplete/expired documents and open document findings as directed.

Knowledge and Skills:

• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCP applicable regulations and CRG 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
• Welldeveloped critical thinking skills including but not limited to: critical mindset indepth 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

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 100000 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!

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.