Senior Clinical Research Associate

3 giorni fa

Italia Catalyst Clinical Research, LLC A tempo pieno

As a Senior Clinical Research Associate , you are responsible for monitoring clinical trials and ensuring investigators are conducting research within the requirements of the clinical protocol and ICH-GCP. You will be involved in all stages of clinical trials, including the identification of an investigational site and setting up, initiating, monitoring, and closing down a trial. You will work closely with the project team to ensure compliance with appropriate regulations and guidelines throughout the trial and will conduct data analysis to ensure this meets the required clinical standards. You will ensure the rights and safety of human subjects involved in a clinical study are protected at all times.

Position Accountabilities/Responsibilities:

  • Participate in the investigator recruitment process, performing initial qualification visits of potential investigators and evaluating the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.
  • Work with the study start-up group to coordinate activities with the site in preparation for the initiation of studies.
  • Manage regulatory authority applications and approvals, obtaining regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
  • Set up trial sites, ensuring that each center has the necessary trial materials.
  • Work with the study start-up group and site staff to obtain regulatory (IRB/IEC) approval of study-specific documents.
  • Ensure study documentation is maintained in the Investigator Study File and where necessary ensure relevant documents are transferred or copied to the (electronic) Trial Master File.
  • Perform study initiation activities, reviewing with the site personnel, the protocol, regulatory issues, and study procedures.
  • Provide training on completion of the eCRF; monitoring activities and study close-out activities.
  • Train site staff on the EDC system and verify site computer system.
  • Monitor trials throughout their duration, conducting periodic site file audits to ensure compliance with GCP and the company’s standard operating procedures.
  • Ensure adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
  • Perform validation of study data against source documentation as required by the sponsor and prepare monitoring reports and letters as necessary.
  • Document accountability, stability, and storage conditions of clinical trial materials as required by the sponsor.
  • Perform investigational product inventory and ensure return of unused materials to designated location/verify destruction as required.
  • Review the quality and integrity of clinical data through in-house review of electronic CRF data and on-site source verification.
  • Work with sites to resolve any data queries as required.
  • Assist with and attend investigator meetings for assigned studies.
  • Develop and review protocols, eCRFs, study manuals, and other related documents as requested by the Clinical Trial Lead.
  • Coordinate with the ethics committee to ensure the rights, safety, and well-being of all trial subjects including provision of updates according to local requirements.
  • Act as the primary contact between Catalyst and the investigator, coordinating all correspondence and ensuring timely transmission of clinical data with the study site and technical reporting as necessary.
  • Assist with final data review and query resolution through to database lock.
  • Perform study close-out visits and archive study documentation and correspondence.
  • Act as a mentor for new clinical research associates.

Supervisory Requirements/Responsibilities:

  • Strategic thinking.
  • Ability to act decisively.
  • Motivating performance.
  • Working collaboratively.
  • Coaching and developing others.

Position Qualifications and Requirements:

Education: Degree or equivalent qualification in life sciences or allied discipline with proven experience in the field of monitoring ideally early phase Oncology, Rare Diseases, Cell and Gene Therapies.

Experience: 2+ years of monitoring experience with strong focus on oncology.

Required Certifications: N/A

Required Skills:

  • Sound knowledge of clinical research process and medical terminology.
  • Good understanding of electronic data capture, including basic data processing functions.
  • Good understanding of current ICH-GCP (R2) guidelines applicable to the conduct of clinical research.
  • Willingness and ability to travel domestically (and occasionally internationally) as required.
  • Proven ability to lead and influence at study sites and in a fast-paced and collaborative environment.
  • Excellent verbal and written communication and interpersonal, negotiation, and conflict resolution skills.
  • Strong organizational skills with an ability to multi-task and work independently.
  • Strong technical skills using PowerPoint, Excel, and Word.

Working Conditions: Sedentary work that primarily involves sitting/standing. Employee may be office or home-based with regular business travel.

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