Clinical Trial Coordinator Job in Auckland Recruiting by Merck Sharp & Dohme (Australia) Pty. Limited

Job Description Clinical Trials Coordinator Permanent full-time role with competitive renumeration and benefits This role will be office based in our Newmarket – Auckland – NZL office Work with a high performing, agile and passionate team As a Clinical Trial Coordinator (CTC), you will play a key role in providing administrative support to our company's Global Clinical Trial Operations (GCTO) across Australia and New Zealand What You Will Do Responsibilities include, but are not limited to Trial and site administration 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 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 Collaborate with finance/budgeting representatives for 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 Planning Organize meetings (create & track study memos/letters/protocols) Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable) What You Must Have Tertiary degree in Science or related field, or in absence of this, proven working experience (office management, administration, finance) in Clinical Research or healthcare Demonstrated solid work experience in Clinical Research or healthcare Good understanding of Global, Country/Regional Clinical Research Guidelines, ICH/GCP and ability to work within these guidelines Hands on knowledge of Good Documentation Practices Excellent written & verbal communication skills with internal and external customers (e.g., sites and investigators) Good IT skills (e.g., MS Office, MS Teams, Clinical Trial Management Systems) and ability to adapt to new IT applications Effective time management, organizational and conflict management skills Ability to set priorities and handle multiple tasks simultaneously in a changing environment Work effectively in a matrix multicultural environment Proactive attitude to solving problems and proposing solutions What You Can Expect Be critical in integrating your skills within a Global leading organisation. Joining a collaborative team of likeminded individuals Be developed and supported in your role and growth of your career We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status Regular Relocation VISA Sponsorship Travel Requirements Flexible Work Arrangements Hybrid Shift Valid Driving License Hazardous Material(s) Requisition ID R280719 #J-18808-Ljbffr