
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
đĽ 13 hours ago
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
⢠Review assigned protocols and related documentation for accuracy, feasibility, timing, and resources ⢠Prepare and maintain Investigator Site Files and/or Trial Master Files ⢠Participate in timelines, start-up meetings, Investigator Meetings, Site Initiation Visits, and sponsor discussions ⢠Coordinate study start-up activities, clinic logistics, schedules, team training, source documents, CRFs, laboratory workbooks, staffing, and study supplies ⢠Confirm regulatory and contractual documentation before study start ⢠Support the Principal Investigator with delegation logs, daily task management, visit calendars, and monitor visits ⢠Advertise, recruit, and screen potential study participants ⢠Perform study activities in accordance with Good Clinical Practices ⢠Manage multiple clinical trials simultaneously and protect participant safety ⢠Collect and enter study data; complete Case Report Forms and submit data on time ⢠Coordinate screening and assist with informed consent ⢠Facilitate study-data audits and respond to auditor data-clarification inquiries ⢠Coordinate clinic visits, including admission, dosing, randomization, discharge, and follow-up ⢠Provide on-call support when applicable ⢠Screen eligibility and oversee, coordinate, and/or perform study-drug administration as delegated ⢠Monitor study activities for compliance with protocol, SOPs, and applicable regulations ⢠Manage adverse-event reporting, study logs, trackers, quality control, and monitor findings ⢠Coordinate QC, monitor, CRF, and other findings through resolution ⢠Oversee study close-out documentation, deviation reporting, CRF completion, TMF updates, logs, supply returns, IRB reports, and archiving ⢠Monitor participant compliance and escalate participant or study issues ⢠Prepare for and participate in sponsor, monitor, and QA audits ⢠Provide timely project-status updates to Project Managers and sponsors ⢠Collaborate on process improvement, SOP creation/revision, meetings, and company initiatives ⢠Coordinate and perform regulatory activities, including protocol, consent, amendment, and yearly renewal submissions when requested ⢠Report trial-related adverse events and maintain study files ⢠Perform other assigned work-related duties
⢠Registered Nurse and/or University Degree such as Bachelor of Science Degree required ⢠Clinical Research certification preferred ⢠Minimum of 1 year of experience in clinical research required; 2+ years preferred ⢠Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines ⢠Problem solving, planning, and evaluation skills ⢠Good time management; detail-oriented and able to multitask ⢠Good interpersonal and communication skills with a team focus ⢠Knowledge of SOP writing ⢠Ability to anticipate problems and provide timely solutions ⢠Ability to coordinate multiple clinical research projects with competing deadlines ⢠Proficiency in Word, Excel, and PowerPoint ⢠Proficiency in clinical trial EDC software preferred ⢠Ability to accommodate a flexible schedule, including days, afternoons, nights, and weekends ⢠Travel up to 100% ⢠Equivalent experience, skills, and/or education may be considered
⢠Temporary part-time employment ⢠Remote (Pre-Approved) designation ⢠Flexible schedule accommodating days, afternoons, nights, and weekends
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