Clin Research Coordinator Ii- Barcelona

hace 7 días

Barcelona, Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo

Description

JOB SUMMARY:

Coordinates or co-leads assigned clinical research projects in accordance with Protocols, Standard Operating Procedures (SOPs), and applicable regulations.

Frequency of onsite support: 2days a week

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 startup meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings).
  • Take the lead and/or overall coordination of all required startup 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.
Clinical Conduct

  • Perform all study activities following Good Clinical Practices (GCP).
  • Manage multiple clinical trials simultaneously.
  • 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.
  • 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 studyrelated 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.
  • Review and/or oversee closeout of study documentation, deviation reporting, CRF completion and signoff, and other studyrelated reports/documentation.
  • Review and update TMF documentation.
  • Finalize study and/or volunteer logs.
  • Ensure completion of other closeout activities as required (return of study supplies, IRB reports, archiving, etc.).
  • 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 companyrelated initiatives and goals.
  • Accommodate flexible schedule (available days, afternoons, nights, and weekends).
  • Perform other workrelated duties as assigned.
Coordinate and Perform 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%

Frequency of onsite support: 2days a week

Qualifications

QUALIFICATION REQUIREMENTS

  • Registered Nurse and/ or University Degree such as Bachelor of Science Degree required.
  • Clinical Research certification preferred.
  • A 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 guid

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