Start-up Specialist - Leeds, United Kingdom - Fortrea

Fortrea
Fortrea
Verified Company
Leeds, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Start-Up Specialist - UK Based - Remote or Hybrid (Leeds or Maidenhead)


Grade:
P1-2


Location:
Role can be remote or hybrid/office based (Leeds or Maidenhead)

Are you experienced in regulatory compliance, site selection, and contract negotiations?

Do you have a strong track record in successful site initiation and ethics committee submissions?

Are you ready to excel in a pivotal role, coordinating trial start-up activities and shaping the future of innovative early phase studies?


Join Fortrea's growing team of more than 19,000 employees in over 90 countries who help in developing life-saving healthcare solutions into the world as quickly and efficiently as possible.


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.

Fortrea's Early Phase Start-Up team is currently recruiting for a Start-Up Specialist.

You will play a key role across all aspects of start-up including regulatory compliance, site identification & selection, contract negotiation, ethics committee submissions and document preparation.


Key Responsibilities- Ensure documents are filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time.- Independently collect, review, process, and track regulatory and investigator documents required for effective and compliant study site activation.- Ensure that all assigned start up activities are on track and support study deliverables.- Proactively manage sites to ensure timely site activation.- Participate in team meetings to progress trials and identify site issues that might impact the timelines.

Escalate study issues appropriately and in a timely fashion.- When needed, assist in preparation of Site Activation project specific plans.- Provide accurate projections and timelines to study teams agreed with Sponsor.- Review and update study documents when there are changes in study personnel/study amendments.

Liaise with Fortrea Regulatory department regarding document submission requirements, if applicable. Independently prepare submissions to IRB/IEC.

Liaise with applicable IRB/IEC regarding submission/approval issues.- Ensure high quality site documents are filed in the (e)TMF in a timely manner according to study plans.

Review and negotiate site contracts, confidentiality non-disclosure agreements, and other related documents in accordance with defined processes and timeframes.- Liaise with Sponsor, Fortrea Contract Specialist, and other team members as appropriate to finalize site contract language.- Liaise with Investigator Grant team, Clinical Operations team, and sites to develop, modify, and monitor site budgets and payment terms.- Obtain signatures on site contracts in accordance with defined process and timelines.- Proactively track progress of contract and budget milestones, intervening and escalating as appropriate.

Manage changes to site contracts for amendments and work scope change.- Undertake tasks delegated by senior team members, depending upon country and situational requirements.- Perform other duties as assigned by management.


Experience:


Minimum Required:

  • Minimum 2 years of experience in clinical development or regulatory process.
  • Working knowledge of ICH, FDA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator startup documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
  • Demonstrated understanding of research protocol requirements and proven ability to communicate with/educate others about them.
Education/Qualifications


Recommended:

  • University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution.
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.

For more information about Fortrea, visit

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.

We make employment decisions based on the needs of our business and the qualifications of the individual an
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