Covance

Clinical Study Start-Up Specialist - (SSU/RSU Associate)

Job Location(s) AU-Sydney | AU-Adelaide | AU-Melbourne | AU-Perth | AU-Brisbane | AU
Job Number
2021-76052
Job Category
Clinical Study Start Up
Position Type
Full-Time
Telecommute
Yes

Job Overview

Are you ready to discover you next career at Labcorp Drug Development?
We are seeking an exceptional person with study startup experience that is focussed on advancing their career in Clinical Research to the next level.
Our Clinical Research Study Start up Specialists provide our clinical operations team with support to start up clinical Phase I - IV clinical projects in APAC. Based at home or in our office in Sydney you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.
 
Joining us as a Startup Specialist you will:
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Collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance

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Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines.

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Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.

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Proactively manage sites to ensure timely site activation and escalate study issues appropriately and in a timely fashion.

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Participate in team meetings to progress trials and identify site issues that might impact the timelines.
When needed, assist in preparation of Site Activation project specific plans and provide accurate projections and timelines to study teams agreed with the Sponsor Review and customize country and site specific patient informed consent forms for compliance with local requirements and protocol.

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Proactively resolve informed consent issues and other potential difficulties with study sites.

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Liaise with Labcorp Regulatory department regarding document submission requirements, if applicable.

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Prepare submissions to IRB/IEC, and regulatory authorities if Global Regulatory Services (GRS) requires input. Liaise with applicable IRB/IEC and/or regulatory authorities (if applicable) regarding submission/ approval issues.

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Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Labcorp ready for an audit at any time.

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Sport the negotiation of site contracts and budgets with sites, if applicable and tck progress of contract and budget milestones/developments, intervening and escalating as appropriate.

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Perform other duties as assigned by management.

 
Labcorp Australia is committed to providing employees the freedom to grow careers across all phases and areas of clinical trial operations as well as provide regular support to develop your experience.
 

Education/Qualifications

 
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.

Experience

 
- Typically 2 years of experience in clinical development or start up/ regulatory process.
-  Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites
- Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them

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