Senior Specialist, Regulatory Affairs
Location: Santiago Metropolitan, Chile
Requisition Number: 1596
Position Title: Senior Specialist, Regulatory Affairs
The Site Activation and Regulatory Specialist is responsible for supporting end-to-end site start-up from pre-award feasibility to site activation and maintenance serving as the primary point of contact for the site. This includes supporting pre-award site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, site start-up activities pertaining to Regulatory Authorities submissions under the direction of the Regulatory Affairs team; and liaison with sites to support contracts/budget negotiation under the direction of the Site Contracts team.
Additional responsibilities will include ED collection, tracking & review and provision of country/site requirements to support achievement of site activation goals and on-going maintenance activities in compliance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).
Tasks may include but are not limited to:
- Supports the collection of country and site level intelligence, as per Worldwide internal procedure.
- Performs pre-award feasibility studies for potential sites as requested.
- Supports the development of a preliminary potential site list.
- Supports Site Identification activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Site Identification Questionnaires.
- Conduct remote pre-study site visits (where applicable and allowed by sponsor).
- Supports the development and adaptation of country/site specific informed consent forms.
- Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities.
- Interfaces with relevant functional leads to ensure appropriate prioritization of essential document collection and review to facilitate synchronized start-up.
- Collects, receives, perform first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study specific plans.Implements corrective action as needed, prior to essential document review sign off and follow up on Non-Hold items post sign off (where applicable).
- Tracks study-specific site regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the Project Manager or Site Activation Lead.
- Where applicable, provide local follow up and updates of status of local EC submissions to the Regulatory Affairs and relevant teams assigned to the project.
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate.
- Conducts training of other SASs as requested and appropriate
- Supports of translations as per Worldwide internal SOP.
OTHER SKILLS AND ABILITIES:
- Excellent oral and written communication skills.
- Excellent planning and organizational skills with effective time management.
- Excellent interpersonal skills.
- Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- Ability to work in an organized, methodical and self-motivated manner.
- Thorough understanding of clinical research principles and process.
- Thorough understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and country/local regulatory requirements.
- Ability to proactively identify and solve problems.
- Thorough understanding of standard operating procedures.
- Proficient knowledge of Microsoft Office and other contemporary software applications.
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
- Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and a minimum of 2 years experience with clinical research (e.g. study coordinator, CTA, etc.)
- Preferable CRO/pharmaceutical industry experience.
- Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English.
State: Los Rios
Employment Type: Regular
Community / Marketing Title: Senior Specialist, Regulatory Affairs
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Zagreb, HR