**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Able to lift 40 lbs. without assistance **Job 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.** **Location/Division Specific Information** **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.** **Job Overview:** Reporting to the Clinical Operations Supervisor, the CDA ensures accurate filing of CRFs and source documents for research studies, collaborating with sponsors. **Essential Functions:** + Develop a filing system for each study to ensure accessibility and completeness of subject folders. Maintain order and audit all required forms for accuracy, flagging any discrepancies for resolution. + Review protocols and CRFs to determine study-specific information. Identify gaps and consult with the Supervisor and Clinical Research Manager to establish clear criteria for CRF completion. + Ensure accurate and timely completion of study CRFs to align with sponsor requirements and deadlines. + Ensure the principal investigator signs all CRFs, addressing any data issues promptly. + Ensure all study participants’ paperwork is complete and aligned with FDA requirements. Box completed study information following the clinical archival process, resolving any sponsor queries post-study. + Ensure all case report forms and subject folders undergo QA review before sponsor evaluation or PI signature. + Prepare sponsor rooms prior to visits. **Qualifications:** Education and Experience: + High/Secondary school diploma or equivalent with relevant vocational qualification. + Previous experience (0 to 2 years) that provides the necessary skills and knowledge for the role. + A combination of education, training, and directly related experience may be considered equivalent. **Knowledge, Skills and Abilities:** + Proven ability to manage multiple responsibilities and projects with overlapping priorities. + Basic digital literacy, including proficiency in Microsoft Office and adaptability to various data management systems. + Strong interpersonal skills with the capacity to explain complex information clearly. + Ability to work closely with diverse individuals in potentially challenging environments. + Outstanding attention to detail with strong planning and organizational skills. + Effective time-management skills and the ability to communicate the need for assistance when necessary. **Management Role:** This position does not entail management responsibilities. **Working Conditions and Environment:** + Work is conducted in an office or clinical setting. + Expect frequent long hours, including weekends and holidays. + Exposure to blood and biohazardous waste. + Availability by cell phone after hours. + Occasional travel may be required. **Physical Requirements:** + Frequent vertical or stationary standing for 6-8 hours per day. + Repetitive hand movements required. + Frequent mobility, bending, and twisting of the upper body. + Light to moderate lifting and carrying of objects up to 15-20 lbs. + Proficiency in accessing and using various computer software. + Ability to communicate and understand moderately complex information. + Frequent interaction with diverse groups. + Ability to apply basic principles to conceptual issues. + Capability to perform under stress and multitask effectively. + Regular and consistent attendance is essential. 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.