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Job details

Location
Gordon
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35958_1612943575
Contact
Jillian Swoyer
Posted
18 days ago

Job details

Location
Gordon
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35958_1612943575
Contact
Jillian Swoyer
Posted
18 days ago

Benefits

  • Opportunity to be contracted within a Global Pharmaceutical Company with large pipeline of oncology studies

  • Fast paced environment with scope to take full ownership of studies from start up to close out

  • Homebased with option to work in the office as needed

  • Competitive salary with opportunities to grow within the business

About The Company

This opportunity will be within a Global CRO reporting directly to a single sponsor. This market leading pharmaceutical company is expanding their team to take on a variety of new studies and indications into the coming year with a specific focus on oncology. Experienced Clinical Research Associate II (CRA II) are needed on a permanent, full time basis.

About the opportunity

The CRA II is responsible for the site initiation, interim monitoring and closure of an agreed number of centres in clinical studies according to Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations.

Responsibilities

  • Verifies the process of obtaining informed consent has been adequately performed and documented for each participant and demonstrates confidentiality of each patient/ participant

  • Assess factors that may affect safety of participants and clinical data integrity

  • Assess site processes, conduct source document reviews or appropriate site source documents and medical records

  • Verify required clinical data entered into the case report forms are accurate and correct

  • Initiate, monitor and close study sites in compliance with Procedural Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.

  • Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.

  • Update database and other systems with data from centres as per required timelines.

  • Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.

  • Perform source data verification according to SDV plan.

  • Ensure data query resolution.

  • Ensure accurate and timely reporting of Serious Adverse Events.

Skills and Experience

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience

  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

  • Strong computer skills and ability to embrace new technology

  • Ability to travel up to 75% on a regular basis (when boarder closures allow)

Click apply or contact Jill Manson at jmanson@hpgconnect.com

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