Per Diem Clin Research Coordinator II… at Syneos Health · USA-LA-Cl…

Summary: Syneos Health is a global organization providing clinical research services to the pharmaceutical and healthcare industries. They are seeking a Per Diem Clinical Research Coordinator II to manage clinical trial activities, ensure compliance with protocols, and support the Principal Investigator in various study-related tasks. Responsibilities: - Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources - Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study - Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings) - Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following: - Clinic logistics planning, schedule of clinic activities, and team training - Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules - In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study - Confirms all required regulatory and contractual documentation is present prior to study start - Support the Principal Investigator as needed with study related tasks such as, but not limited to: - Delegation of Authority Log - Management of daily tasks - Visit calendar development and maintenance - Scheduling and attending monitor visits - Advertise, recruit, and screen potential participants for the study - Perform all study activities following Good Clinical Practices (GCP) - Manage multiple clinical trials simultaneously - Protect the safety of human subjects - Monitor appropriate sources for specific clinical study or federal regulation updates - Collect and enter study data into the appropriate system - Coordinate and monitor screening activities; provides support as required - Assist with informed consent of study subjects - Submit data in required timeframe - Monitor appropriate sources for specific clinical study or federal regulation updates - Complete Case Report Forms - Facilitate audits of study data - Develop patient rapport to explain research protocols and minimize protocol violations - Develop rapport with study team to educate team on study procedures and minimize protocol violations - Respond to inquiries by auditors for data clarification or additional data in required timeframe - Take the lead and/or overall coordination of clinic activities including, but not limited to: - Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable - Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required - In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations - Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings - Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings - Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation - Review and update TMF documentation - Finalize study and/or volunteer logs - Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.) - Responsible for monitoring subjects’ compliance throughout the trial and address day-to-day. subject or study issues and escalate as appropriate - Prepare for and participates in sponsor/monitor/QA audits - Provide accurate and timely project status updates to Project Managers and sponsor - Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, and other company-related initiatives and goals - Accommodate flexible schedule (available days, afternoons, nights, and weekends) - Perform other work-related duties as assigned - Maintain proper protocol, consent, amendment, and yearly renewal submission if requested - Report adverse events relating to the trial - Maintain study files Required Qualifications: - Registered Nurse and/ or University Degree such as Bachelor of Science Degree required - A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects - Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines - Required skills: problem solving, planning, and evaluation - Possess good time management, detail-oriented, and able to multi-task - Good interpersonal and communication skills with a team focus - Knowledge of SOP writing - Ability to anticipate problems and provide solutions in a timely manner - Ability to coordinate multiple clinical research projects with competing deadlines - Proficiency in computer software programs (e.g. Word, Excel, Power Point) Preferred Qualifications: - Clinical Research certification preferred - 2+ years preferred - Proficiency in use of various clinical trial EDC software preferred Required Skills: Clinical Research, Registered Nurse, Clinical Research certification, ICH GCP, SOP writing, Clinical trial EDC software, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Team focus Benefits: Company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, Eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, Flexible paid time off (PTO) and sick time