Clinical Trial Assistant with Finance expertise

Il y a 4 mois

RueilMalmaison, France PAR Fortrea France SARL Temps plein

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. 
 

We have job openings for Clinical Trial Coordinators with finance expertise to be office based in Paris, France. 

The Clinical Trial Coordinator will support tasks associated with study start-up initiation and would need to have had previous expertise in handling the financial parts of clinical projects.

Responsibilities associated with this position:

Trial and site administration:
o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers

o To serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites
o Clinical supply & non‐clinical supply management, in collaboration with other country roles
o Manage Labeling requirements and coordinate/sign translation change request
• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents
o Assist with eTMF reconciliation
o Updating manuals/documents (e.g., patient diaries, instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Execute eTMF Quality Control Plan
o Obtain translations of documents

o Managing relations with hospitals and clinical research directories (DRCI)

o Negotiations of hospital contracts (convention unique)

o Preparation and validation of hospital overheads, in collaboration with project manager

o Provide support in managing vendors

o Invoice follow-up with sites


2) Regulatory & Site Start‐Up responsibilities:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start‐up and submissions
o 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 legislation


3) Budgeting, Agreement and Payments: Collaborate with finance/budgeting representatives for:
o Develop country and site budgets (including Split site budget)
o Tracking, and reporting of negotiations
o Maintenance of tracking tools
o Working knowledge of Contract development, negotiation, approval and maintenance (e.g. CTRAs)
o Update and maintain contract templates (in cooperation with Legal Department)
o Payment calculation and execution (investigators, vendors, grants)
o Ensure compliance with financial procedures
o Monitor and track adherence and disclosures
o Budget closeout.
o Obtain and process FCPA documentation in a timely manner


4) Meeting Planning:
o Organize meetings (create & track study memos/letters/protocols)
o Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable

Experience requirements:

Must be bilingual in French and English Ability to drive and possess a valid driver’s license Ability and willingness to present at internal and external meetings Must previous experience in hospital contracts negotiations, preparation and validation of hospital overheads, vendor’s management and invoicing.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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