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Job Title: Site Start Up SpecialistJob Description

As a Clinical Site Start Up Specialist, you will be responsible for developing awareness of regulatory legislation, guidance, and practices in assigned countries with the support of senior staff. You will assist in compiling, preparing, submitting and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements. Your job will also include liaising with internal and external vendors in the generation of Regulatory Authority submissions. You will perform reviews of final submission documents, organize communication related to the submissions/outcomes within our organization, and escalate study issues appropriately and timely. You will also serve as a primary contact for investigative sites and ensure all necessary documents are collected in a timely manner. The role includes ensuring that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines. You will also be responsible for updating study documents when there are changes in study personnel/study amendments and ensuring high quality documents are filed and systems are updated on an ongoing and timely basis. With guidance from the line manager and experienced colleagues, you'll adapt Informed Consent Forms and other patient facing material to country-specific requirements. The role may also involve supporting/assisting the contract negotiation process under the supervision of an experienced colleague or line manager.

Responsibilities

+ Develop awareness of regulatory legislation, guidance, and practices in assigned countries.

+ Assist in compiling, preparing, submitting, and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority.

+ Liaise with internal and external vendors for the generation of Regulatory Authority submissions.

+ Perform reviews of final submission documents and organize communication related to the submissions/outcomes.

+ Escalate study issues appropriately and timely.

+ Serve as a primary contact for investigative sites and ensure timely collection of necessary documents.

+ Ensure that all assigned maintenance and start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality, and applicable laws and guidelines.

+ Update study documents when there are changes in study personnel/study amendments.

+ Adapt Informed Consent Forms and other patient-facing material to country-specific requirements.

+ Support/assist the contract negotiation process under supervision.

Essential Skills

+ Contracts and negotiation of budgets and contracts.

+ Regulatory review and start-up processes.

+ Experience with IRB, TMF, and clinical research.

Additional Skills & Qualifications

+ Strong communication skills.

+ Problem-solving abilities.

+ Attention to detail.

+ Proactive approach.

Work Environment

This is a 100% Work From Home position. The successful candidate must be able to work on East Coast timezone hours (Monday - Friday) 8-5PM EST. The role is fully remote and can be based anywhere in the USA.

Pay and Benefits

The pay range for this position is $28.00 - $38.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jul 22, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.