**Work Schedule** Other **Environmental Conditions** Office **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. Discover Impactful Work: Under the general direction of the Research Team Leader, the Research Team CDA is responsible for the successful completion and filing of case report forms and source documents for clinical research studies. Works with sponsor representatives at all meetings/visits when case report form data is reviewed. Ensures all subject data is boxed as required for study archiving. A day in the Life: Develops filing system for each study, to ensure each subject folder will be accessible to others if necessary. Ensures each folder is eventually complete and orderly with all required forms completed and audited for accuracy. Flags any discrepancies in data to be resolved by appropriate staff. Ensures proper documentation to the study file addressing any study issues so all aspects of the study are clear even years after study is completed. Reviews protocol and case report forms (CRFs) to determine study specific information. Evaluates for gaps in information and discuss omissions with Team Leader and Project Manager to develop clear criteria for case report form completion. Ensures accurate and timely completion of study CRFs to meet sponsor requirements and deadlines. Informs Research Team Leader and Project Manager of any issues/problems, which may cause delays. Ensures principal investigator signs all CRFs and is apprised of any data issues on the study. Ensure all study participants’ paperwork is complete and adequately reflects participation in the study as per FDA requirements. Boxes completed study information in accordance with the clinical archival process. Resolves any sponsor queries after the study has been completed. Ensures all case report forms and subject folders are reviewed by QA prior to review by sponsor or signature by PI. Sets up sponsor rooms prior to sponsor visit. Keys to Success: Education High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience. Bachelors Degree preferred. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills, Abilities Demonstrated ability managing multiple responsibilities and completion of projects in either a work or school setting. Basic computer skills including knowledge of Microsoft Office and the ability to learn various programs and/or systems such as the Oracle database. Strong communication skills. Ability to clearly explain information to a wide variety of individuals. Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings. Strong attention to detail. Strong planning and organization capabilities to manage multiple tasks and multiple study groups at one time. Effective time-management skills. Strong auditing and documenting skills. Ability and willingness to learn to administer investigational drugs or test investigational devices. This may include dosing orally, intravenously, topically or other approved dosing methods. Physical Requirements / Work Environment Work is performed in an office or clinical environment with exposure to electrical office equipment. Occasional drives to site locations. Potential Occasional travel required. Frequent long hours, weekends and/or holidays Exposure to blood and biohazardous waste Be available by cell phone after hours Exposure to fluctuating and/or extreme temperatures on rare occasions Physical Requirements: Frequently stationary for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. May interact with others, relating and gathering sensitive information. Interaction includes diverse groups. Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! 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.