MSD Internship Clinical Trial Coordinator 

Australia, New South Wales 

307492474

Job Description

Internship Clinical Trial Coordinator

• Permanent Full-timeposition with competitive renumeration and benefits

• The ideal candidate will be based in Sydney, Australia

• Work with a high performing, agile and passionate team

• To be successful in this role, your knowledge, passion, and enthusiasm on clinical research and trial is key.

You will be coached, and mentored by our qualified, experienced, and professional clinical trial team in Australia and New Zealand

Trial and site administration and management:

• Track (e.g. essential documents) and report (e.g. Safety Reports)

• Ensure collation and distribution of study tools and documents

• Update clinical trial databases (CTMS) and trackers

• Clinical supply & non-clinical supply management, in collaboration with other country roles

• Manage Labelling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

Document and data management:

• Prepare documents and correspondence

• Collate, distribute/ship, and archive clinical documents, e.g. eTMF

• Assist with eTMF reconciliation

• Execute eTMF Quality Control Plan

• Update manuals/documents (e.g., patient diaries, instructions)

• Document proper destruction of clinical supplies.

• Prepare Investigator trial file binders

• Obtain translations of documents

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

• In a timely manner, provide to and collect from investigators forms/lists for site

• evaluation/validation, site start-up and submissions

• Obtain, track and update study insurance certificates

• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

• Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments:

• Develop, control, update and close-out country and site budgets (including Split site budget)

• Develop, negotiate, approve and maintain contracts (e.g. CTRAs)

• Track and report contract negotiations

• Update and maintain contract templates (in cooperation with Legal Department)

• Calculate and execute payments (to investigators, vendors, grants)

• Ensure adherence to financial and compliance procedures

• Monitor and track adherence and disclosures

• Maintain tracking tools

• Obtain and process FCPA documentation in a timely manner

Meeting Attendance & Planning:

• Organize meetings (create & track study memos/letters/protocols)

• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

• Strong communication and interpersonal skills

Requirements:

• Strong communication and interpersonal skills

• Strong attention to detail and good analytical skills

• MS Office skills (MS Excel, MS Word, MS Powerpoint etc.)

Knowledge of SAP based system, Power BI or other visualisation too (optional)

Qualification & Experience:

• Completed job training (office management, administration, finance, life sciences, engineering, project management, health care preferred) and/or Bachelor’s Degree

Current Contingent Workers apply

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