For Employers

Novotech Global

Inhouse Clinical Research Associate - Australia

Posted 2 hours ago
0-2 years experience
Apply Now

Please mention DailyRemote when applying

?Not checked yet0100
Resume Match Score

See how much of this job your resume covers, and what’s missing.

Want a recruiter to go through it line by line?

Get professional review

Tailor your resume to this job

One click makes a copy of your resume for this role, scores it against the posting, and proposes edits line by line. Your default resume is never changed.

  • Job match score for this posting
  • Edits you accept or skip, no invented facts
  • Download it when it reads right: TXT free, PDF with Premium

Create a cover letter for this job

Upload your resume and we draft a letter for this exact role, tailored to what it asks for.

  • Tailored to this role
  • Based on your resume
  • Fully editable
AI Summary

The Inhouse Clinical Research Associate provides support to the clinical team by managing study documentation, Trial Master Files, and the Clinical Trial Management System. They also coordinate trial materials, assist with monitoring visit preparations, and support regulatory submission processes.

The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.

Responsibilities

  • Support the clinical team’s inhouse activities on assigned projects.
  • Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
  • Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
  • Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF’s, ensuring accuracy and completeness of the data.
  • Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
  • May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
  • May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.

 

Minimum Qualifications & Experience:

  • Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
  • A minimum of 1 years experience as inhouse CRA or relevant clinical administration roles.


Novotech is a global full-service clinical Contract Research Organization (CRO).


At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide. 


At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.


With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.


At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model, so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. 

At Novotech you will work alongside empowered teams with a shared commitment to success.

  • Strategic vs transactional mindset.
  • Ability to gain insights and make proactive decisions quickly.
  • Culture that fosters partnership and collaboration, where every voice is heard and valued.
  • Ongoing support from senior stakeholders and leadership team.
.

Automatically Apply to the Best Remote Jobs

Stop the endless job search. Our AI finds and applies to the best jobs for you.

Try it Now
Keep looking

Similar Jobs

See all Remote Healthcare jobs →

Pediatric Speech Therapist - Early Intervention, Washington PA

Full Time United States Healthcare

Pediatric Speech Therapist - Early Intervention

Full Time United States Healthcare

Pediatric Speech Therapist - Early Intervention, Cumberland County, PA

Full Time United States Healthcare

Registered Nurse

Full Time United States Healthcare

Physical Therapist

Full Time United States Healthcare

Staff Physician, 24/7 Care (Full-Time / 100% Remote)

Full Time United States $143K per year Healthcare
Apply Now

Personalize your Remote Job Search in 3 Easy Steps!

Featuring 225,556+ Jobs in Healthcare

Answer easy questions

Answer easy questions

225,556+ jobs across 15+ categories

Get your best job matches

Get your best job matches

Only hand-screened, legit jobs

Find a remote job faster

Find a remote job faster

No ads, scams, or junk

“I was the first applicant for a remote marketing position that got listed on the company website the same day I applied. Had an interview within 48 hours!”

Sarah J. — Sarah J. · Marketing Manager ★★★★★ Verified