• Forecasts submission/approval timelines and ensures they are adhered to. Provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. May serve as the primary point of contact for the Project Manager, Clinical Lead, Regulatory Start-up Manager (or designee) during start-up on allocated projects.

• Prepares ongoing submissions, amendments, required by central and local EC/IRB, as required by local rules. Submits end of study notifications to ECs/IRBs and other local authorities in the specified country according to national timelines.

• Performs/oversees essential document collection and review, ensuring that sponsor and investigator obligations are being met and comply with applicable local regulatory requirements and ICH/GCP guidelines.

• Local Investigator Contract and budget negotiator (where applicable) produces site-specific contracts from country template.  Submit proposed contract and budget to the site for review.  Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.

• Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.

• May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.

What We Are Searching For:

• Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional

• 5+ years of direct study start up experience 

• Thorough knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.

• Thorough knowledge of the relevant country specific regulatory requirements for conducting clinical trials and of site and institution specific contract requirements

• Expertise in the development and review of Informed Consent Form templates, other patient documents, or specific documentation that is required in the country.

• An excellent team player with the ability to develop and maintain strong relationships across the organization to provide awareness of future issues and promote collaboration and problem-solving.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $90,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.