What are the responsibilities and job description for the Study Start Up Specialist position at Labcorp Drug Development, Labcorp?
Study Start-Up Specialist
Remote - United States
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com
Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks – working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.
We are seeking a Study Start Up Specialist to be responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to improve site activation and maximize patient recruitment time.
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
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 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
Requirements:
The incumbent should have a bachelor’s degree (or equivalent) and minimum of 2 years of experience in clinical development including start up/ regulatory process experience.
Understanding of ICH-GCP essential documentation and familiarity with country specific clinical trial regulations
Demonstrated ability to quality review documents and identify discrepancies/inconsistencies preferred.
Ability to embrace Veeva Clinical Vault system and associated functionality.
Strong written and verbal English communication skills
Flexibility to adapt to changing business needs and priorities.
Demonstrated organization skills and attention to detail.
Strong service orientation
Ability to work independently and manage multiple tasks and priorities.
COVID-19 vaccination required.
Pay Range: $53,000 - $112,000/year
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.
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Salary : $53,000 - $112,000