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Job details

Location
Macquarie Park
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35695_1612398008
Contact
Christine Covero
Posted
about 1 month ago

Job details

Location
Macquarie Park
Salary
Negotiable
Job Type
Full Time
Ref
BBBH35695_1612398008
Contact
Christine Covero
Posted
about 1 month ago

Benefits

  • Opportunity for growth and development within leading sponsor.
  • Work in an innovative and adaptable environment.
  • Supportive team with good leadership and flexibility to work from home.
  • Guaranteed completion bonus 10%

About The Company

Market leading pharmaceutical company is expanding their team to take on a variety of new studies and indications into the coming year. Experienced SCRA/CRAs are needed to focus on oncology, respiratory and a variety of therapy areas on a 12 month rolling contract basis.

About the opportunity

The S/CRA is responsible for the preparation, initiation, 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. Deliver according to the commitment in the individual trials.

Responsibilities

  • Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in the office and at site.
  • Actively participate in local Study Delivery Team meetings.
  • Contribute to the selection of potential investigators.
  • Train, support and advise Investigators and site staff in study related matters.
  • Contribute to national Investigators meetings.
  • 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.
  • Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
  • Provide the required monitoring visit reports within required timelines.
  • Work with data management to ensure quality of the study data.
  • Ensure compliance with company's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

Skills and Experience

  • University degree in related discipline, preferably in life science, or equivalent qualification.
  • Ability to travel nationally as required.
  • Minimum of 1 year local independent monitoring experience
  • Fluent knowledge of spoken and written English.
  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge preferably experience in monitoring Oncology studies.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
  • basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge preferably experience in monitoring Oncology studies.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

Click apply or contact Christine Bristol at cbristol@hpgconnect.com

( SK924529A )

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