Lead CRA

Bavarian Nordic A/S

Studiejob
Nordsjælland
Udlandet (øvrige)

Lead CRA

Job Title: Lead Clinical Research Associate
Reports To: VP, Clinical Operations
Department: Clinical Operations

PRIMARY RESPONSIBILITIES:
This position requires approximately 60% travel with the primary responsibility to monitor key sites and to perform oversight visits for sites being monitored by either a CRO or contract CRA. The secondary responsibilities include supporting the operation and execution of domestic clinical trials, including coordinating activities associated with start-up, maintenance and closure of clinical trial sites

Job Responsibilities:

  • Organize and manage clinical site visits where they will monitor the clinical sites and results of clinical investigations
  • Conduct study visits, assessing potential study sites to insure the facility, staff and patient population are sufficient for study conduct
  • Review case report forms, follow action items to completion, develop a strong working relationship with site and team personnel, train site personnel on study related procedures
  • Ensure clinical site data meets quality standards and is entered in a timely manner
  • Responsible for drug reconciliation at the site. Monitoring of drug accountability and temperature deviation reporting
  • Communicate deviations from the protocol, SOPs, GCP/ICH, and the applicable regulatory requirements to the Investigator as required
  • Identify and escalate site, vendor and study related issues to CPL, as appropriate
  • Prepare confirmation letter, monitoring reports and follow-up letters per SOPs.
  • Assist in the development, maintenance and aggregation of key study metrics, including updating and tracking clinical trial progress and providing status update reports and study metrics
  • Provide support to the CPL as needed for clinical protocol and amendment development
  • Assist in development and/or review of study tools (such as Delegation of Authority log, Investigator binder, source document worksheets, eCRFs and eCRF guidelines, etc.) and guidelines to be utilized by study sites
  • Create trial related material and presentations for Investigator and coordinator meetings and present at these meetings
  • Coordinate and review regulatory documents from study sites; ensures completeness and accuracy
  • Communicate status of clinical study and issues to CPL and clinical study team
  • Partner with team members and other functional areas within BN such as Clinical Science, Regulatory, CQA, Data Management to accomplish clinical study team goals
  • Ensure all trip reports are reviewed and all action items are followed up per SOPs

Knowledge, Skill and Competency Requirements:

  • Excellent verbal and written communication skills required
  • Must be able to effectively express ideas and incorporate feedback into deliverables to generate quality output
  • Must be fluent in English
  • Must have strong knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must have a solid understanding of therapeutic indications and the study protocol

Requirements for Position:

  • BS preferably in a relevant biological or health science discipline
  • Requires 5 years working as a CRA in a pharmaceutical or biotech environment
  • At least 3 years of oncology experience is required
  • Must be able to travel domestically and internationally as required, up to 60% of the time
  • Must be able to work independently in a fast-paced environment

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships and industry collaborations. The company was founded in 1994 and has been listed on the Nasdaq Copenhagen Stock Exchange since 1998. Headquartered in Kvistgaard, Denmark and with operations in Munich, Germany and North Carolina, USA, the company employs more than 400 people. Bavarian Nordic is an Equal Opportunity Employer.

www.bavarian-nordic.com

Join Bavarian Nordic and take a step into the future of vaccines. Our goal is to develop innovative and safe therapies against cancer and infectious diseases to improve the health and quality of life for children and adults.

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Studiejob
Nordsjælland
Udlandet (øvrige)
Kemi, Biotek & Materialer
Medicinal & Sundhed
Naturvidenskab
Data & analyse
Forskning & Udvikling
Medicinal & Sundhed
Naturvidenskab



Bavarian Nordic A/S - hurtigt overblik


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Hejreskovvej 10A
3490 Kvistgård
Logo: Bavarian Nordic A/S
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