Study Start Up Associate

19 hours ago

Port Melbourne, Australia Labcorp Full time

We are Labcorp, a leading global life sciences company, named by Fortune magazine's 2021 List of World’s Most Admired Companies. Thanks to the more than 70,000 amazing employees around the globe who make Labcorp a great place to work we continue to make the world a healthier and better place.

**The Opportunity**

The Start-up Associate’s main responsibility is to collect, track and perform a quality review of all essential & investigator documents required for effective and compliant study site activation and maintenance.

You will also ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, budget, quality and applicable laws and guidelines.

**Responsibilities (but not limited to)**
- Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner
- With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements
- May support / assist the contract negotiation process under supervision of an experienced colleague or line manager
- Escalate study issues appropriately and in a timely fashion
- Update study documents when there are changes in study personnel/study amendments
- Contribute to the preparation of submissions to IRB/IEC with appropriate supervision
- Ensure high quality documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time
- Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision

**Experience**
- 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)
- Minimum 0 - 2 + years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
- Demonstrated basic understanding of the clinical trial process

Find out more about Labcorp here

Labcorp one of the Forbes World's Best Employers in 2021

Labcorp Australia is committed to providing you the flexibility to work from home, the freedom to grow & develop your career across all phases and areas of clinical trial operations, as well as provide state of the art technology and processes that help to give you time back to enjoy family life.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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