Senior Clinical Research Associate I (scra I) – Perth, Wa at Labcorp Drug Development (Perth)

Job Description

Are you ready to discover your next career with Labcorp Clinical FSPx?

We are seeking an exceptional Senior Clinical Research Associate (SCRA I) with independent site monitoring experience to join our growing Clinical FSPx team in Perth, Western Australia.

Allocated to a global pharmaceutical company who has an outstanding reputation for recognizing their employees, you will enjoy working on one set of SOPs, monitoring local WA sites and have the flexibility to work from home. You will also be employed permanently by Labcorp giving you the best of both worlds to develop and broaden your career across our exceptional company.

So, if you are passionate about Clinical Research and a person who has experience independently monitoring global Phase I – IV clinical study sites across Australia, let’s talk as we may have a job for you.

As a Senior Clinical Research Associate at Labcorp you will:

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

Responsible for all aspects of site management as prescribed in the project plans

General On-Site Monitoring Responsibilities:

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

Monitor data for missing or implausible data

Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy

Ensure audit readiness at the site level

Travel, including air travel, may be required and is an essential function of the job.

Prepare accurate and timely trip reports

Manage small projects under direction of a Project Manager/Director as assigned

Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned

Review progress of projects and initiate appropriate actions to achieve target objectives

Organize and make presentations at Investigator Meetings

Participate in the development of protocols and Case Report Forms as assigned

Participate in writing clinical trial reports as assigned

Interact with internal work groups to evaluate needs, resources and timelines

Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

Responsible for all aspects of registry management as prescribed in the project plans

Undertake feasibility work when requested

Conduct, report and follow-up on Quality Control (QC) visits when requested

Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

Assist with training, mentoring and development of new employees, e.g. co-monitoring

Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Perform other duties as assigned by management

Why join the team?

Labcorp in 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.

Interested? Why not explore your potential in a company that truly invests in you; Talk to us to learn more and explore your career.

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, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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This job vacancy was been posted over 40 days ago, but is still active and currently accepting new applications.

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