Senior CRA

Location Netherlands
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Merel van Os

Contact email: m.vanos@panda-int.com
Job ref: 10647
Published: about 1 month ago

For a thrilling assignment at a leading CRO I am looking for a Senior CRA to participate in the preparation and execution of Phase I-IV clinical trials! Main responsibility will be monitoring clinical trials in accordance with GCP and managing and conducting clinical studies. Let’s get in touch to discuss all the excellent benefits and details!
 

OFFER

  • Employment contract with opportunity to help shape the improvement of Clinical Trials and the success of a leading CRO and her partners.
  • Competitive salary, performance-related bonus and attractive fringe benefits
  • Personal development is key! Lots of possibilities to grow and move internally.
  • A great emphasis on teambuilding with organized events and coffee dates! Although it’s a large company you will feel part of a team immediately.
  • A leading and stabile company to work for, during COVID they continuously hired people and kept on growing.
  • The thrill of working with a highly motivated team and a highly supportive international leadership team.

RESPONSIBILITIES

  • Participates in the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
  • Coordinate activities with the site and internal departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
  • Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring blinded and un-blinded visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in SOPs.
  • Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.
  • Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
  • May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
  • Serves as primary contact; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
  • Assists with, and attends, Investigator Meetings for assigned studies.
  • Attends study-related, company, departmental, and external meetings, as required.
  • Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
  • Serves as mentor for junior CRAs and those new to the company and/or study.

PROFILE

  • Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
  • Experience working with systems like eCRF and EDC.
  • Experience in monitoring and/or coordinating clinical trials required.
  • Experience in blinded and/or un-blinded monitoring visits.
  • Preferred experience in Oncology (Phase I,II,III)
  • Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
  • Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
  • Able to handle several priorities within multiple, complex trials.
  • Able to reason independently and recommend specific solutions in clinical settings.
  • Able to work independently, prioritize, and work within a matrix team environment.
  • Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

INTERESTED?

If you’re interested in this thrilling adventure, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below. For further information, please contact Merel van Os at +31 (0)20 20 44 502 or by email at m.vanos@panda-int.com