Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team.

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.

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 ICH-GCP. Interaction with CA/EC for study purposes and handling responses to the CA/EC.

and essential document review criteria. Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. Customize country/site specific Patient Information Sheet and Informed Consent Form.

Responsible for/facilitates the translation and co-ordination of translations for documents. , Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.

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 execution 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 May support the clinical team performing Pre-Study Site Visits. The ideal candidate will have: Minimum Required: Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.

A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

Responsibilities

and to keep Regulatory Leadership Preparation/Support the development of study specific start-up plans, IMP release

Regulatory and Start Up Specialist / Senior Regulatory and Start Up Specialist