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Location

Carlsbad, CA | United States

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Job description

Job Description

If you are a Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

Responsible for the day to day activities of a Clinical Research Associate (CRA) including set up, monitoring and completion of clinical trials in accordance with Jazz SOPs, ICH-GCP, and relevant local and international regulatory guidelines (i.e., EU Directive 2001/20/EC, Commission Directive 2005/28/EC/ The US Food and Drug Administration FDA Code of Federal Regulations Title 21 – Food & Drugs Good Clinical Practice Parts: 11, 50, 54, 56, 312 and 314).

Essential Functions/Responsibilities

• Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and company guidelines.
• Ensures the rights, safety and wellbeing of clinical trial subjects is maintained.
• Performs site monitoring activities including:
  • site evaluation visits
  • site initiation visits
  • site interim monitoring visits
  • site closeout visits
• Collaborates with the Clinical Trial Working Group (CTWG) to drive subject recruitment.
• Establishes and maintains regular contact with Investigators, vendors, and trial sites to ensure compliance with applicable regulations and the protocol.
• Maintains cGxP knowledge applicable to the job.
• Provides additional training and mentoring to new and novice team members, as required.
• Assists in study feasibility analysis, country assessment, site identification and subject recruitment and planning.
• Co-ordinates local IRB/IEC submissions and any required local submissions with the Jazz Clinical Team Manager (as applicable).
• Assists CTWG in study start-up activities including site selection and document collection.
• Reviews essential documents, including the local translation of essential documentation (e.g., Patient Information Leaflets).
• Coordinates study site payments where required.
• Prepares/reviews study documentation (e.g., CMP, CRF completion guidelines, Protocol, pharmacy manuals).
• Liaises with CTWG to ensure all study requirements are arranged (e.g., central laboratory support, equipment).
• Provides training of clinical trial study staff at site initiation on all study procedures and throughout the duration of the study as required.
• Performs routine on-site interim monitoring visits including source data verification of CRF's, query resolution, essential document maintenance, review of patient source documentation and IMP accountability as required per protocol.
• Ensures proper storage, dispensing, accountability, receipt and return of clinical study materials.
• Reviews adverse events reports and ensures site is reporting the events appropriately and in a timely manner.
• Ensures site compliance with trial protocols, ICH-GCP and applicable regulations.
• Works with site personnel and study team to prevent, address and resolve issues.
• Communicates project specific information to/from trial sites and documents communication with study site/project team and escalates issues to CTWG in a timely manner.
• Assists in development of enrolment strategies and recruitment plans with the CTM, providing information specific to each study site.
• Executes additional tasks to meet departmental project-related or developmental/change objectives.

Required Knowledge, Skills, and Abilities

• Knowledgeable of ICH-GCP, and relevant local and international regulatory guidelines, as applicable.
• Fluency in English and in the relevant native language. For bilingual employees, perform simple translations (e.g., CRA/site communications), where applicable.
• Possess strong verbal and written communication, interpersonal and organisational skills.
• Have a high degree of accuracy and attention to detail.
• Ability to drive and be available for domestic and international travel including overnight stays, as required.
• Flexible and adaptive approach to work.
• Able to work in a team and as an individual.
• Ability to identify issues and resolve appropriately with guidance.
• Ability to process visit reports and expenses claims in a timely manner to an acceptable, quality.

Required/Preferred Education and Licenses

• BSc (or equivalent) in a life science or healthcare discipline, pharmacy degree or nursing qualification AND a minimum of 3 years monitoring of clinical trials in the pharmaceutical/CRO or biotechnology industry.
• A minimum of 5 years’ experience of monitoring clinical trials in the pharmaceutical/CRO or biotechnology industry is required where no BSc or equivalent qualification is held.
• Competent with standard and job specific computer applications including Microsoft Office, SharePoint and Electronic Data Capture systems.
• Previous experience with risk-based monitoring approaches.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US-BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $100,000-$131,250. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits

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