Start-Up Specialist II, Remote USA

Job Overview:

Study Start Up Specialist

Remote - USA based

We are seeking a Study Start Up Specialist to be responsible for activities related to study start up and ongoing study document management and act as point of contact for local study teams and external stakeholders.

In this role you will be responsible for the start-up of clinical trial activities in their assigned country/countries to achieve greenlight for selected sites. Specialist also performs quality review of essential documents at start up and during the lifecycle of the study, ensuring adherence to ICH-GCP guidelines, local requirements and client QSDs.

Additional responsibilities include:

Interact with site and study personnel to collect country specific documents such as IRB/IEC approvals, financial disclosure, CVs/medical licenses, etc. and review for accuracy, completeness and adherence to ICH/GCP and client QSDs

Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study

Prepare and submit regulatory and IRB/IEC documentation as required per country requirements and client QSDs during the course of the study

Preparation, tracking, and distribution of site start up documentation including Investigator Site File

Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met

Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards

Monitor internal start up KPIs across studies and identify and communicate trends

Support start up process improvement implementation

In collaboration with CRA, maintain and ensure accuracy of site information in Vault

Assist with audits/inspections of relevant start up activities and/or eTMF

Attend and actively participate in team meetings by providing site greenlight projections and timelines

Provide input on site activation strategy

Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva

Education/Qualifications:

Bachelor's or Master's degree in Life Sciences or equivalent

2 years of industry related experience, including handling of trial start-up activities coordination of trial start-up activities and Health Authority / Ethic Committee submissions

COVID-19 vaccination required

Experience:

Thorough understanding of GCP, ICH Guidelines and Country regulatory environment

In depth knowledge and understanding of clinical research processes, regulations and methodology

Demonstrated organizational and planning skills and independent decision-making ability

Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives

Strong organization and time management skills and ability to effectively manage multiple competing priorities

Ability of critical thinking and risk analysis

Strong English (oral & written) and local language capabilities in (Ex-US)