Site Activation Partner I – FSP, Fixed-Term 7 months

This is a fully remote position, open to applicants in Mexico, +2 more countries.

📋 Description

• Lead or assist in operational tasks from study initiation through to close-out for designated studies and investigator sites.

• Initiate and manage activities along with the essential document handling for Investigator Initiation Packages and site activation.

• Register and maintain investigator sites and client stakeholders in client registries and systems.

• Engage with investigator sites to confirm readiness for start-up and review site profiles, necessary documents, contracts, supplies, payments, and IRB information.

• Address and escalate site-related issues within specified timelines.

• Prepare, validate, and submit regulatory documents for internal approval.

• Coordinate supporting roles and activities to ensure the prompt activation of sites.

• Assist with Central and local IRB/Ethics Committee packages, submissions, communications, and approvals.

• Aid in the management of non-clinical trial supplies, tracking, clinical documentation, filing, and archiving.

• Support the readiness of electronic Investigator Site Files and manage access prior to Site Initiation Visits.

• Coordinate in-scope document translations.

• Manage study documents and updates throughout the study, including protocol amendments, FDA 1572/Attestation revisions, and annual Ethics Committee approvals.

• File documents in the Trial Master File and assist in quality reviews and audits/inspections.

• Maintain clinical trial systems to track site compliance and performance.

• Communicate updates regarding the study, country, and site, including approvals, issues, delays, and escalations to stakeholders.

• Provide awareness sessions for site personnel on client requirements and compliance.

• Complete assigned training and comply with EP and client SOPs and processes.

• Learn and possibly implement site activation processes across multiple countries.

• May serve as the study Point of Contact, Subject Matter Expert, global initiative representative, or mentor.

⛳️ Requirements

• A minimum of 2 years of experience in start-up activities within the US/Canada.

• At least 3 years of relevant experience in clinical site management, specifically in the US/Canada.

• A high school diploma/certificate along with an equivalent combination of education, training, and experience.

• Familiarity with clinical trial methodologies, ICH/GCP, FDA, and both global and local country regulations.

• Strong verbal and written communication skills.

• Good technical skills with the ability to learn and operate multiple systems.

• Understanding of clinical research and development processes, along with key operational elements of a clinical trial.

• Capability to comprehend quality expectations and demonstrate compliance with company, regulatory, and country requirements.

• Attention to detail and a disciplined approach.

• Ability to work both independently and collaboratively as part of a team.

• Skills in organizing tasks, managing time and priorities, and multitasking.

• Basic understanding of medical terminology and GCP requirements.

• Proficient in computer operations.

• Fluency in the local language as well as English.

• A Bachelor of Science, Bachelor of Arts, or Bachelor’s in Life Sciences is preferred.

• Experience in the pharmaceutical industry or CRO, particularly in study site activation, is preferred.

• Multilingual capabilities are preferred.

🏝️ Benefits

• Opportunity to transition into a full-time position following the 7-month temporary assignment.

• Training provided by the client and EP, covering general training requirements, SOPs, and system and process-related training.

• Potential opportunities for mentoring and serving as a subject matter expert.

• Involvement in global initiatives.

• Chance to support the mentoring of new hires.