[Hiring] Regulatory and Site Start Up Specialist @Precision Medicine Group

Role Description

Due to our continued growth we are seeking a Regulatory and Site Start Up Specialist. The Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up 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.
• Providing support to the Site Contract Management group in budget and contract negotiation.
• Acting as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others).
• Contributing to development or revision of country specific tools and guidance documents.

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 and submission dossier for submission to CA, EC, and other applicable local bodies.
• 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.
• Maintenance of project plans, project trackers and regulatory intelligence tools.
• Preparation/Support the development of study specific start-up 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 co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating in country start up.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points.
• Participate/support the negotiation of study budgets and the execution of investigator contracts.
• May participate/support feasibility group in site outreach to assess potential interest of investigators.
• Keep an updated knowledge of the local clinical trial laws, regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan.
• May support the clinical team performing Pre-Study Site Visits.
• May support process improvement initiatives, training, and mentoring.
• Performs other duties as assigned by management.

Qualifications

• 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.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.

Requirements

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country.
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.

Company Description

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 life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.