job details for:
Clinical Research - Clinical Research Associate Jobs - Netherlands

Clinical Research - Clinical Research Associate Jobs - Netherlands (Job Ref: WR/JOBS/24093-10367)

Job Description :

Flame Pharma Clinical Research - Clinical Research Associate Job (CRA) - Netherlands:

Job Summary

This leading contract research organisation that has unrivalled reputation for conducting global clinical development programs of the highest integrity, has a fantastic opportunity for an experienced Clinical Research Associate (CRA) for there Netherlands site.

Job Title

Clinical Research Associate

Background

Due to expansion, our client is looking to recruit a Clinical Research Associate to have Primary responsibility in site management and performance (including required documentation) according to ICH guidelines (country specific guidelines and government regulations), as well as FDA regulations (state and local laws), GCPs, and SOPs. Site management activities include all in house and on-site monitoring for all visit types after observation and supervision of these visits by an experienced monitor and assessment by manager.

Key Responsibilities

• Assist with the identification and contacting of potential investigators;
• Ensure adequacy of clinical research staff/facilities with regard to Standard Operating Procedures (SOP) and global regulatory requirements and identifies issues and problems for resolution by lead Clinical Research Associate (LCRA).
• Conduct site initiation visits.
• Ensure completion of regulatory documents; reviews investigator responsibilities;
• Attend investigator’s meetings and as appropriate help with the preparation of the materials to be presented.
• Assess and manage overall investigational site performance including assisting with site issues such as enrollment.
• Ensure investigators’ adherence to protocol and initiates corrective action to resolve issues (with input from Lead CRA or manager).
• Provide frequent updates to the Trial Master File during interim monitoring period
• Review Case Report Forms (CRF) for completeness and accuracy and ensures corrections are appropriately made.
• Review Adverse Event incidence, both serious and non-serious, and follows reporting procedure to sponsor.
• Review Data Clarification Form (DCF) resolution.
• Ensure Investigational Product (IP) accountability.
• Assure site compliance with Institutional Review Board or Independent Ethics Committee (IRB/IEC) reporting obligations.
• Prepare visit reports within study timelines utilising acceptable business writing skills
• Maintain regular telephone contact with site and assist with study help-lines as needed.
• Maintain study specific tracking files and databases
• Track investigator payment status, if applicable.
• Communicate all issues and updates with study management including Project Manager and Lead CRA as appropriate.
• Perform in-house clinical CRF review, if applicable.
• Review and retrieve remaining CRFs
• Resolve all outstanding DCFs.
• Ensure IP accountability and reconcile IP for return and/or disposal per sponsor guidelines.
• Review record retention requirements with Clinical Investigator.
• Review possibility of audits/inspections with Clinical Investigator.
• Secure and review investigator’s final report within Sponsor SOPs or guidelines.
• Completes core clinical training program and develops independent monitoring skills
• Responsible for writing basic clinical study documents (visit reports, correspondence, etc.)
• Performs administrative duties, including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions, etc.

Qualifications and Experience

• B.A. /B.S. in the science/health care field, nursing degree, or equivalent
• Clinical research experience in CNS or Oncology and other related research experience
• Direct clinical research experience and knowledge of procedures related to clinical trials is necessary
• Requires thorough knowledge of ICH Guidelines, FDA regulations, (or other country specific guidelines), GCPs, and medical terminology.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
• Requires strong organisational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment.
• Basic computer skills in Word, Excel and Email are necessary
• A willingness to travel up to 75% of time is essential.

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary circa 30,000E

Key Words

Clinical Research Associate, CRA, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

This vacancy will be based in The Netherlands

For further information on this vacancy, please contact Flame Pharma