Assiatant CRA

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 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.