Associate Regulatory and Start Up Specialist III

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies expertise and operational scale to help the life sciences improve the speed cost and success rate of bringing lifechanging therapies to patients. What sets us apart is the way we integrate clinical trial with deep scientific knowledge laboratory expertise and advanced data sciences.

As our organisation continues to grow we are hiring an Associate) Regulatory and Start Up Specialist I / II to join our team in Spain. This position can be offered fully home based.

Job Description

Position Summary :

The (Associate) Regulatory and Start Up Specialist I / II is an entry level professional in regulatory and site startup activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB / Ethics Committees Informed Consent Form review and adaptation Essential Document collection and quality review supporting sites on IRB / EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The (Associate) RSS I / II will be guided by a more senior RSS with additional support from other incountry members supporting site startup activities.

Essential functions of the job include but are not limited to :

• Responsible for delivery in terms of timeliness and quality of site activation readiness within the assigned country / sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments / notifications) for submission to CA EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations / approvals for the conduct of the Clinical Trial according to international and local / national applicable regulations company SOPs and principles of ICHGCP.
• Interaction with CA / EC for study purposes and handling responses to the CA / EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and / or Regulatory Lead assigned to the study and to Project Manager / Project Team as relevant.
• Maintenance of project plans project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
• Preparation / Support the development of study specific startup plans IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare review and manage collection of essential documents required for site activation / IMP release.
• Customize country / site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for / facilitates the translation and coordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e. Feasibility Clinical Operations Project Management Regulatory and Site Contracts management group on project specific status and deliverables.
• With oversight collect and maintain site level critical path to Site Activation data points including but not limited to Competent Authority local IRB / Ethics Committee (EC) timelines site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• When required participate / support the negotiation of study budgets and the of investigator contracts under directions of Site Contract Management department / designee department.
• May participate / support feasibility group in site outreach to assess potential interest of investigators to a potential study.
• Keep an updated knowledge of the local clinical trial laws regulations and help distributing their knowledge within PfM to ensure the conduct of Clinical Trials according to international and local / national applicable regulations.
• Maintain audit / inspection readiness at all times and file documents as per TMF plan and / or study specific plans in the relevant TMF.
• Performs other duties as assigned by management.

Qualifications : Minimum Required :

Other Required :

Preferred :

Competencies

LIEK1 #LIRemote

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race color age religion sex sexual orientation gender identity national origin disability veteran status or other characteristics protected by law. 2020 Precision Medicine Group LLC

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Required Experience :

Key Skills

Business Intelligence,Category Management,Drawing,Electrical Controls,Academics,Graphics Design

Employment Type : Full Time

Experience : years

Vacancy : 1