Clinical Research Assoc. I Mea

2 days 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 Clinical Research Associate - MEA (CRA Trainee) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the CRA trainee shall reflect their experience, and level of contribution which they can make to the project. The work will involve Clinical Operations activities which will be conducted in an office or home based setting for designated projects as well as some travel to conduct site visits or to attend client or internal team meetings as needed. The CRA trainee will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliance with Company or Sponsor SOP, regulatory standards and applicable guidelines.

**Responsibilities (but not limited to)**

1)To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.

2) To monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.

3) To assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).

4) To perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.

5) To assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.

7) To liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.

8) To liaise with Study Start-up and assume maintenance activities after Site Activation. Maintenance responsibilities including but not limited to: revision of FDA form 1572 or equivalent, Medical license expiration, CV (if applicable), Laboratory Certificate expiration, Protocol Signature Page collection, Investigators Brochure acknowledgement of receipt, Institutional Review Board submission/Approval for Annual Renewals and PI Changes.

9) To proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.

10) To demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.

11) To liaise with the CTA to assist the Project Team in the production of Status Reports.

12) To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the Clinical Team Leader (CTL) and Project Manager.

13) To assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region

14) General On-Site Monitoring Responsibilities

**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)
- A combination of education and experience to successfully perform the key responsibilities of the job
- Working knowledge of ICH - GCP and other applicable regulations/guidelines.
- Demonstrated basic understanding of the clinical trial process

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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