Clinical Trial Coordinator (Regulatorio)

Job DescriptionUnder the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA.Responsibilities include, but are not limited to:

• Trial and site administration: o Track (e.g. essential documents) and report (e.g. Safety Reports)

o Ensure collation and distribution of study tools and documentso Update Clinical Trial databases (CTMS) and trackers.

• Document management:

o Prepare documents and correspondence.o Collate, distribute/ship, and archive clinical documents, e.g. eTMFo Assist with eTMF reconciliationo Execute eTMF Quality Control Plano Update manuals/documents (e.g., patient diaries, instructions)o Prepare Investigator trial file binderso Obtain translations of documents

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

o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissionso Obtain, track and update study insurance certificates o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.o Publish study results for GCTO and RA where required per local legislationSkills:

• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills

• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Hands on knowledge of Good Documentation Practices

• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.

• ICH-GCP Knowledge appropriate to role

• Excellent negotiation skills for CTCs in finance area

• Effective time management, organizational and interpersonal skills, conflict management

• Effective communication with external customers (e.g. sites and investigators)

• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

• Demonstrates commitment to Customer focus, both internally and externally.

• Able to work independently • Proactive attitude to solving problems / proposing solutions

• Positive mindset, growth mindset Qualification & Experience:

• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree

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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: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: No Travel RequiredFlexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): N/AJob Posting End Date: 06/20/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.