Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
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 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 execute high-quality, cost-efficient clinical studies.
As an Assistant CRA, you will support the execution of clinical studies by performing remote activities in collaboration with the Remote CRA, On-Site CRA, and Study CTM. You will contribute to site preparedness, provide logistical and operational support throughout the monitoring process, and assist with tasks related to site management and remote monitoring in compliance with SOPs and regulatory requirements. You may also be assigned limited site-contact responsibilities during study start-up, site management, recruitment, and close-out phases.
Essential Functions:
Completes study and site management activities as defined in task matrix, applicable and directed for study assigned.
Completes and documents study-specific training.
Orients and trains on any 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.
Supports 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.
Follows 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 CRA 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 Requirements:
Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
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
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
Working Conditions and Environment:
The Assistant CRA role does not involve regular travel, however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).
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.