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Herakles Pharma

Clinical Research Associate

Functiegroep: Clinical Operations
Locatie:Amsterdam
Werkweek:40 uur
Procedure: W&S
Vacature ID:#510
Publicatiedatum:08-12-2017

Clinical Research Associate

De organisatie

Our client is actively recruiting for a Clinical Research Associate to join their expanding global company in the Netherlands, home or officebased opportunity. You can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Our client is a dynamic andprivately owned company with a presence in over 50 countries worldwide. They have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. They have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

De functie

The Clinical Research Associate will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure ensuring compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget. Summary of the job description:

Responsibilities of the Clinical Research Associate:

  • Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel, and other medical contacts. Assess potential Investigators and their sites.
  • Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators.
  • Recommends sites for consideration in future studies, as needed.
  • Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or Protocol Managers. Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements.
  • Reviews site activities and quality through on-site visits in addition to emote management capabilities.
  • Monitors study sites following the monitoring plan, SOPs, protocol, ICH/GCP Guidelines and other local regulations as applicable. This includes, but is not limited to: Managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
  • Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP
  • Guidelines and local regulations. Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities.
  • Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them to meet study objectives, including enrollment and retention goals. Resolves study site problems/issues as they occur. More complex issues may be resolved jointly with management. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective actions are implemented.
  • Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position profile, in the available systems. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team.
  • Facilitates the Regulatory Compliance audit process, as needed.
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.
  • Identifies opportunities to interact, builds and strengthens professional and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues,etc.).
  • Uses multiple technologies to maintain open and frequent communication with all stakeholders.
  • Exhibits flexibility and adaptability when facing change.
  • Employs good fiscal management for travel expenses, etc.
  • Ability to perform site management activities, as required.

Het profiel

Essential requirements for the function as a Clinical Research Associate:

  • Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline;
  • Clear understanding of the drug development process;
  • Significant experience in performing a Clinical Research Associate role;
  • Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company;
  • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials;
  • Ability to contribute to the development of clinical trial related documents and materials;
  • Ability to independently perform pre-study initiation, interim monitoring and close out visits as required;
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines;
  • Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail;
  • Fluency in English and (both written and spoken);
  • Willingness and ability to travel;

Het aanbod

Besides a market conform benefit package they offer an excellent environment to improve yourself. You can decide and act, connect and collaborate with your colleagues, improve and innovate. This environment offers you guarantee to grow.

Inlichtingen bij

Interested in this opportunity as a Clinical Research Associate? Please respond via this page. For questions please contact Albert Hollemans via albert@heraklespharma.nl / 06-22639519 (evening hours are no problem)

Meer informatie
Albert Hollemans +31 6 22639519
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