Clinical Research / Trial coordinator - Pharmaceuticals

  • Location:

    Amersham, Buckinghamshire

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    £10 - £12 per hour

  • Job ref:

    BBBH109466_1567502171

  • Published:

    15 days ago

  • Client:

    Undisclosed Company

Clinical Research / Trial coordinator - Healthcare

Amersham

6 Months

Hourly Rate

My client is seeking an experienced Trial Coordinator to join their busy Amersham based team. The successful candidate will have a background in clinical trials, research and governance.


The candidate will work with the Operations Team for managing the lifecycle of all supported Investigator Sponsored Trials and facilitating the efficient operation of the Committee to augment the clinical evidence base for our clients Healthcare products. They will proactively manages all aspects of study-related support across all brands. They will review documentation to verify that all research institutes appropriate GCP, operates within global/regional regulations and complies with guidelines including.

Key responsibilities/essential functions:

  • Support business objectives by facilitating trial review process according to SOP, across multiple business areas, to streamline efficient proposal evaluations based on scientific and medical merit, patient safety, alignment to medical objectives, and budgetary appropriateness including Fair Market Value and permissible support review.
  • Effectively communicate the decisions by establishing followup meetings with key stakeholders.
  • For approved studies assist the IST Responsible Person to ensure relevant workflows are processed, including contract requests; help set milestones according to payment guidelines. Review supporting documentation for compliance and alignment to ISTC decisions; complete Clinical Supply Authorisation for receipt of required documentation and setup product supply process and tracking.
  • Track progress against key milestones via organisational tools including databases, budget tracker, PUT Tool.
  • Build and expand relationships with internal and external customers; including legal, finance, marketing, regulatory affairs, global supply chain, pharmacovigilance, medical affairs, medical expert teams, R&D, external suppliers and key opinion leaders to facilitate project completion within timeframes consistent with IST medical objectives.
  • Request updates according to the approved schedule, incorporate information into the database, PUT tool and budget tracker, in order to prepare effective quarterly finance and study status reports.
  • Place and track orders for contrast media products required.
  • Review invoices for alignment to milestones and obtain proof of milestone achievement.
  • Review workflows relating to milestone funding and product supply for accuracy; check Purchase Order workflows for accuracy; provide justification for Delegation of Authority approval of final contract workflow to Head of GMS.
  • Manage information requests from internal and external customers whilst maintaining the integrity of independent research and safeguarding against potential legal and regulatory noncompliance issues.
  • Maintain IST support central and libraries ensuring all data including medical objectives, ISTC membership lists, folders, reporting, SOPs, links, etc., are upto-date.
  • Continuously monitor Mailbox and FOC (freeof-charge) confirmations mailbox and respond to queries and issues received.
  • Followup and assist with proposals that may connect or revert to Research Agreements, Collaborations, Alliance Contracts, etc., if IST alignment is ruled out.
  • Arrange, prepare and present training for new staff, plus refresher training as needed.

Please submit your CV in the first instance or call Emma Jones on 07483128595.

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