Clinical Research Monitor (Senior CRA)

Hiring By - Biostaffic

 BioPharma

Australia

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Careers That Change Lives
We are excited to be advertising clinical research monitoring roles within ANZ supporting the execution of our clinical trial program. ANZ has become the destination for global trials and as such we are attracting more and more exciting clinical research programs in the region. With the growth of our clinical program, comes the need to grow our clinical team, this is where you come in.
We are looking for Science based graduates as an individual contributor with responsibility in a professional discipline or specialty. someone who is great at building relationships and has an eye for detail. Depending on your experience, you may act as a mentor to colleagues or get involved in some activities across the company to broaden your horizons and leadership skills through the many ERG programs. The majority of time is spent delivering and overseeing the sites that are assigned to you in your projects – from start up activities through to close out activities - while adhering to policies. This position is based in Adelaide.
If you are interested in joining Medtronic’s in-house monitoring team and leverage from overseeing the full life cycle of trial execution and all the products in our several portfolios, that ultimately impact the life of patients around the globe, then Medtronic is keen to hear from you. With a strong pipeline of innovative studies and a variety of newly created roles, there has never been a better time to join us and accelerate or expand your career.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
  • Work directly as a monitor and site manager for the sponsor
  • Sees through entire clinical research protocol from start to end
  • Supports site assessment
  • Helps prepare ethics submission packages
  • Helps oversee clinical trial conduct at their respective chosen sites
  • Conduct monitoring visits on site or remotely depending on the trial per protocol requirements
  • Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
  • Develops and maintains liaison with clinical investigators, , affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
  • Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
  • May assist with design, development, and monitoring of clinical evaluation projects.
  • Trains investigators and site personnel on the device use and protocol through conducting SIVs.
  • Implements and prepares the clinical development strategy as outlined by the Clinical Director and the project teams.
  • May contact and recommend qualified investigators to perform studies and initiate clinical trials.
  • Drive recruitment strategies at your sites
  • Ensures recruitment and retention of patients.
  • Device management
  • Support the site with on time data entry
  • See study execution through to study close out
  • Work enterprise wide across a number of different devices and therapies
  • Be involved in process improvement initiatives internally and in trial conduct
  • Conduct clinical trials in ANZ to Medtronic SOPs
Must-Have:
  • Bachelor’s degree, and minimum of 3+ years o relevant monitoring experience in a Medical Device, Pharmaceutical or CRO setting
  • Eye for detail
  • Strong Interpersonal and communication skills
  • CTMS and eDC experience
  • Experience with Microsoft office suite
Our Offer:
In our 5th Tenet of our Mission, we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.
We believe in rewarding our staff with a complete package of benefits designed to support them at every career and life stage. As a result, our employees have access to the following benefits, to name a few:
  • Health and Wellness allowance to contribute to your general wellbeing.
  • Range of on-demand online health and wellness training resources, apps, videos, and communities
  • We invest in professional training and development for employees at all levels.
  • Our Employee Resource Groups (ERG)- foster awareness and inclusion in the workplace.
  • Various insurance benefits include life and disability, salary continuances, salary sacrifice and Superannuation.
  • We have generous employee referral programs, corporate discount programs, leave benefits, and more!
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health, and extend Life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
Medtronic has been servicing Australia and New Zealand since 1973. We are a Best Place to Work in Australia and certified as a Great Place to Work in Australia and New Zealand. LinkedIn named Medtronic as a top company in Australia in 2021. The AFR has also recognized Medtronic on their' Most Innovative Companies List' in 2019 and 2020. Learn more about working at Medtronic: https://www.medtronic.com/au-en/about/careers.html
At Medtronic, we have an ongoing commitment to fostering a culture of inclusion, diversity, and equality. Therefore, we encourage candidates from all backgrounds to apply, regardless of their culture, religion, identity, ability, or race.
We are committed to achieving a diverse workforce and strongly encourage applications from our Aboriginal, Torres Strait Islander and Māori people.
Should applicants need assistance during the application process for accessibility reasons, we will accommodate this upon request.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Australia

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 13, 2024
Company Overview
Medtronic
Medtronic

Current Openings: 0

A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.
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