Regulatory and Start Up Specialist/Contracts and Budget Specialist

Precision Medicine Group; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Regulatory and Start Up Specialist to join their dynamic team. This role offers the chance to work remotely while contributing to the activation of clinical trials that bring life-changing therapies to patients. You will be responsible for ensuring timely and quality site activation, maintaining project plans, and collaborating with various teams to drive project success. If you possess strong communication skills and a background in life sciences, this is an exciting opportunity to make a significant impact in the field of precision medicine.

Qualifications

• 1+ years as a Regulatory/SU specialist in CRO or pharma/biotech.
• Experience drafting and negotiating clinical research agreements.

Responsibilities

• Responsible for site activation readiness and risk mitigation.
• Maintain communication with key functions for project status.

Skills

Strong communication skills

Organizational skills

Fluency in English

Fluency in Spanish

Education

Bachelor’s degree in life sciences

Registered Nurse (RN)

Advanced degree in medical or life sciences

Tools

Computerized information systems

Electronic spreadsheets

Word processing

Electronic mail

Milestone tracking tools/systems

Job description

Regulatory and Start Up Specialist/Contracts and Budget Specialist

Pay Competitive

Location Remote

Employment type Full-Time

Job Description

• Req#: 5472147004
• 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.
• As our organisation continues to grow we are hiring a Regulatory and Start Up Specialist/Contracts and Budget Specialist to join our team in Spain. This position can be offered fully home based.
• 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.
• Maintenance of project plans and project trackers.
• Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including site contracts and budget negotiation requirements.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.

Experience /Qualifications

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.
• 1 year or more as a Regulatory/ SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Experience drafting, reviewing and negotiating agreements related to clinical research.
• Experience developing and negotiating the budget.

Other Required:

• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and Spanish.

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience.
• 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.

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

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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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].

About the company

With the discipline of precision medicine as our foundation, Precision Medicine Group leverages specialized expertise to move science closer to health.