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Precision Medicine GroupRegulatory and Site Start Up Specialist
Precision Medicine Group operates as a specialized contract research organization uniting advanced technologies, data sciences, laboratory capabilities, and operational scale to accelerate the development of novel…
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About This Role
Precision Medicine Group operates as a specialized contract research organization uniting advanced technologies, data sciences, laboratory capabilities, and operational scale to accelerate the development of novel life sciences treatments. With a primary emphasis on oncology and rare diseases, the company integrates deep scientific knowledge with clinical trial execution. Due to ongoing expansion, the organization seeks a remote Regulatory and Site Start Up Specialist to join the team on a full-time…
Job Description
Precision Medicine Group operates as a specialized contract research organization uniting advanced technologies, data sciences, laboratory capabilities, and operational scale to accelerate the development of novel life sciences treatments. With a primary emphasis on oncology and rare diseases, the company integrates deep scientific knowledge with clinical trial execution. Due to ongoing expansion, the organization seeks a remote Regulatory and Site Start Up Specialist to join the team on a full-time basis.
In this position, the professional manages regulatory and site activation processes to ensure trials launch successfully and on schedule. Responsibilities encompass preparing and submitting documentation to competent authorities and ethics committees, adapting informed consent forms, gathering essential documents, and assisting with budget and contract negotiations. The role suits an experienced clinical research professional possessing a background in regulatory affairs and site initiation within the pharmaceutical, biotechnology, or contract research organization sectors.
The successful candidate collaborates closely with cross-functional teams including clinical operations, feasibility, project management, and site contract groups. Daily duties involve maintaining project tracking tools, addressing regulatory feedback, preserving audit readiness within the trial master file, and serving as a subject matter expert for country-specific startup procedures. Candidates must be comfortable navigating local and international clinical trial regulations while managing documentation quality and delivery timelines.
Responsibilities
- Deliver site activation readiness with proper timeliness and quality while mitigating potential risks
- Prepare and submit clinical trial application forms and dossiers to competent authorities and ethics committees
- Handle responses and interactions with competent authorities and ethics committees
- Maintain project plans, regulatory intelligence tools, and tracking systems while updating leadership
- Review, manage, and collect essential documents required for site activation and investigational medicinal product release
- Customize country and site-specific patient information sheets and informed consent forms
- Coordinate document translations required for regulatory submissions
- Collaborate with clinical research associates to secure site communication and alignment
- Support the negotiation of study budgets and execution of investigator contracts under departmental direction
- Maintain audit and inspection readiness while filing documents within trial master file plans
Requirements
- One year or more of experience as a regulatory or site startup specialist, or in a comparable role within a contract research organization, pharmaceutical, or biotech company
- Strong communication and organizational skills
- Proficiency in utilizing computerized information systems, electronic spreadsheets, word processing, and electronic mail
- Fluency in English and the local language of the employment country if non-English speaking
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor degree in life sciences, a scientific or healthcare discipline, or registration as a nurse or equivalent combination of education, training, and experience
- Relevant regulatory and site startup experience covering feasibility, contract negotiations, and submissions for a specific country
- Experience using milestone tracking tools and systems
- Ability to prioritize workload effectively to meet established deadlines
- Advanced degree in medical or life sciences such as MD, PhD, or PharmD, a RAC certification, or a masters degree in regulatory science
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the posting specifies that the location for this role is remote.
What employment type is this role?
This position is full-time.
What is the salary for this position?
The salary is not stated in the job posting.
What education or experience is required?
Candidates must have a bachelor degree in life sciences or a related field, or be a registered nurse, alongside at least one year of experience as a regulatory or site startup specialist or in a comparable role within the pharmaceutical, biotech, or CRO industry.
Are candidates required to have visa sponsorship?
Yes, candidates must be legally authorized to work in the country of employment without employer sponsorship.
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