Per Diem Clin Research Coordinator II - Onsite in West Monroe, Louisiana

Job Responsibilities Clinical Research Project Planning and Preparation: 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). Lead and/or coordinate all required start‑up activities, including: 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. Collaborate with responsible teams to establish and maintain 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. Confirm all required regulatory and contractual documentation is present prior to study start. Support the Principal Investigator as needed with study‑related tasks such as: 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. Clinical Conduct: Perform all study activities following Good Clinical Practices (GCP). Manage multiple clinical trials simultaneously. Protect the safety of human subjects. Monitor sources for specific clinical study or federal regulation updates. Collect and enter study data into the appropriate system. Coordinate and monitor screening activities; provide support as required. Assist with informed consent of study subjects. Submit data within required timeframe. Complete Case Report Forms. Facilitate audits of study data. Develop patient rapport to explain research protocols and reduce protocol violations. Develop rapport with study team to educate on study procedures and reduce protocol violations. Respond to inquiries by auditors for data clarification or additional data within required timeframe. Lead and coordinate clinic activities, including: Supervise clinic visits (admission, dosing and randomization, discharge, and follow‑up) as required and provide on‑call support when applicable. Screen eligibility prior to randomization; oversee, coordinate and/or perform study drug administration and other activities as delegated. Collaborate with responsible teams to monitor 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. Post‑Clinic/Close‑Out Activities: Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings. 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.). Regulatory Activities: Maintain proper protocol, consent, amendment, and yearly renewal submission if requested. Report adverse events relating to the trial. Maintain study files. Travel up to 100% of the time. General: Accommodate a flexible schedule (available days, afternoons, nights, and weekends). Perform other work‑related duties as assigned. Qualifications Registered Nurse and/or University Degree such as Bachelor of Science required. Clinical Research certification preferred. Minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects (2+ years preferred). Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines. Proficiency in problem solving, planning, and evaluation. Excellent time management, detail‑oriented, and ability to multi‑task. Strong 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 computer software programs (Word, Excel, Power Point) and in the use of various clinical trial EDC software preferred. Benefits Benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401k, eligibility to participate in an Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Eligibility for paid sick time may vary depending on location due to state or municipal regulations. Hourly Pay rate: $49–59 per hour (exact rate will be disclosed in the recruitment process in compliance with applicable wage laws). The position is not currently closed. Applicants are invited to review the qualifications and responsibilities and consider applying. #J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC