- 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: o Clinic logistics planning, schedule of clinic activities, and team training. o 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. o 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. o 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: o Delegation of Authority Log. o Management of daily tasks. o Visit calendar development and maintenance. o 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 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: o Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable. o Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required. o 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. Post-Clinic/Close-Out Activities
- 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. 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.
- 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 guidelines.
- 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).
- Proficiency in use of various clinical trial EDC software preferred
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Clin Research Coordinator Ii- Barcelona - Madrid, España - Pharmiweb
Descripción
JOB SUMMARY Coordinates or co-leads assigned clinical research projects in accordance with Protocols, Standard Operating Procedures (SOPs), and applicable regulationsFrequency of onsite support:
2days a week JOB RESPONSIBILITIES Clinical Research Project Planning and Preparation
Frequency of onsite support:
2days a week Qualifications QUALIFICATION REQUIREMENTS
Required skills:
problem solving, planning, and evaluation.
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
