Senior Clinical Research Associate

7 days ago

London, Greater London, United Kingdom Catalyst Clinical Research Full time
Job Title: Senior Clinical Research Associate

Catalyst Clinical Research is seeking a highly skilled and experienced Senior Clinical Research Associate to join our team. As a Senior Clinical Research Associate, you will play a critical role in the success of our clinical trials, ensuring that they are conducted in accordance with Good Clinical Practice (GCP) and regulatory requirements.

Key Responsibilities:
  • Monitor clinical trials and ensure investigators are conducting research within the requirements of the clinical protocol and ICH-GCP.
  • 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.
  • 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.
  • Developing and reviewing protocols, eCRFs, study manuals, and other related documents as requested by the Clinical Trial Lead.
  • Coordinate with the ethics committee in order 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.
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 a 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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