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SCRA/CRA

Job title: SCRA/CRA
Contract Type: Permanent
Location: Melbourne C B D, Australia
Industry:
Salary: $110000 - $120000 per annum, Benefits: Car allowance+Super
Reference: BH-97458-1
Contact Name: Faiza Khan
Phone Number: 01
Job Published: 20 days ago

Job Description

Clinical Research Associates and Senior Clinical Research Associate (SCRA)- Melbourne/Sydney/Brisbane 

Must have-Full working rights in Australia.


CRA/SCRA is required by a global CRO for a home based/office based positions available nationwide with 50% travel.

  • This is a permanent, full time position multiple openings. The role involves monitoring Clinical Trials in various therapy areas, mainly in Oncology Phase I- IV clinical study sites in Australia.
You will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing top CRO firm, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

Role/Description:

  • To perform the activities associated with the site-level feasibility, evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites in the geographic area assigned.
  • Responsible for Site management, set up, routine monitoring and close out visits
  • Writing monitoring reports
  • Liaising with investigators and other members of a multi-disciplinary team
  • Variety of therapy areas, which may include oncology, cardiovascular, CNS, respiratory and/or infectious diseases
  • Delivering onsite training of investigators and staff.
  • Monitoring trial progress and ensuring that the project timelines are met.
  • To act as an extension of, and whenever appropriate a surrogate in the field for, the TA study teams and other HQ-based Development Operations functions
  • To align execution activities with agreed-upon project priorities, timelines and quality/productivity specification, in compliance with GCP and local laws and regulations governing the conduct of clinical research.
 

Deliverables:
  • Monitoring Plan
  • Clinical site visit reports
  • List of qualified sites following feasibility conduct (shared deliverable)
  • Site specific patient recruitment and retention plans (shared deliverable)
  • Collection of high-quality clinical trial data (CRFs)
  • Query resolution
  • Corrective and preventative action responses to monitoring-related observations on audits and inspections
  • Territory Development strategic plan (shared deliverable)
  • Response to requests for site level study and/or territory information
  • Site Monitor : 50%-60%
The site monitoring role is responsible for the review, collection and submission of essential study documents following site initiation package approval.  The role is also responsible for writing the Monitoring Plan and ensuring input into the plan by the relevant functional lines. As part of the monitoring function, the role conducts Investigator/site evaluation visits, clinical site Initiation visits, clinical site monitoring visits and clinical site close-out visits.  In addition, the role ensures that the clinical study sites are conducting clinical trials in compliance with the respective protocol, applicable ICH/GCP guidelines, laws and regulations, and Allergan procedures. The role identifies site issues and initiates corrective actions with the support of the Site Monitoring and Study Management leadership, and generates responses to site related internal audit findings for management review. The role is responsible for the management of site level tracking and reporting of adverse events (AEs and SAEs) and significant GCP non-compliance, source data verification of case reports and the facilitation of the resolution of clinical queries. In addition, the role ensures the management of adequate site study supplies, requests replenishment from designated personnel, and performs investigational product accountability and reconciliation. 

 
Qualifications:

  • University degree in Life Sciences, Pharmacy, MD or RN or an equivalent combination of education, training and experience.
  • At least 2-3 years of experience at a similar position, with full scope of monitoring responsibilities within Phase I/II/III Clinical Trials.
  • Independent monitoring experience in Australia.
  • Experience in regulatory submissions, contract negotiations, site management and feasibility assessment.
  • Preferably with Experience in Oncology, Infectious Disease or Neurology.
  • Full working rights in Australia.
  • Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
  • A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
.

Please feel free to contact at faiza.khan @ nesgt. com for more information/Call 02-9696 8008.

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