Site Activation Partner​/Study Start Up Specialist - FSP

Location: Puerto Rico

The Site Activation Partner is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to:

Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation

Provide support to resolve issues or concerns and timely escalation of Site issues where applicable

Manage and coordinate with other supporting roles to ensure timely site activation and operational activities

Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required

Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines

Identify and resolve investigator site issues

Experience required for this role:

School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred

Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.

Experience working in the pharmaceutical industry/or CRO is an asset

Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations

Must be fluent in Local language and in English. Multi-language capability is an asset

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.