Job Description

　　Assistant CRA - UK

　　We are currently hiring for a number of Assistant CRAs to join our UK Clinical Operations team. This role can be office based in Bellshill/Cambridge, fully home based or work in a hybrid model with 2-3 days office based per week. This role is suitable for candidates looking to grow in to a travelling CRA position in the future and provides excellent development opportunities.

　　We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services, thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.

　　You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

　　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.

　　Summarized Purpose:

　　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.

　　Essential Functions:

　　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 and Experience:

　　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 and 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 management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively

　　Proven flexibility and adaptability

　　Strong attention to detail

　　Ability towork 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

　　Full, clean UK driving licence

　　full right to work in the UK indefinately

　　Working Environment:

　　PPD clinical research services values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive

　　e support and encourage individuals to create a healthy and balanced environment where they can thrive.

　　Our 4i Values: Integrity – Innovation – Intensity – Involvement

　　If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

　　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.