Study Start-Up Specialist

1 week ago

San Diego, California, United States Vanguard Clinical Full time
Job Summary

Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA. Our mission is to bring innovation to clinical trial execution through passion, transparency, co-active communication, and integrity, to facilitate the successful development of life-changing medicines and therapies.

We are experts in clinical trial operations with a focus on Clinical Trial Management, CRO/Vendor Oversight, Trial Master File Management, Clinical Monitoring, Quality Assurance, Data Management and Study Startup. As a small company, we are highly adaptable, flexible, and transparent. Our unwavering integrity forms the foundation for our strong relationships both internally and as a partner to our Sponsor clients.

Our talented team is driven by passion and purpose, which has afforded us the opportunity to successfully lead clinical programs for pharmaceutical, medical device and biotechnology companies of all sizes in a variety of therapeutic areas. Our mission is to conduct clinical trials with outstanding quality on behalf of our clients to bring new drugs to market with the utmost integrity and confidence in the results.

Key Responsibilities

  • Support study start-up activities, focusing on quality and completeness of the essential documents package.
  • Conduct site-level feasibility assessments, including supporting site qualification.
  • Serve as a liaison with sites to support contracts and budget negotiation.
  • Support site identification activities, including the collection of Confidential Disclosure Agreements and the collection of Site Identification Questionnaires.
  • Support the collection of site-level intelligence.
  • Support the development of a preliminary potential site list.
  • Collect and initiate first review of study-specific site regulatory/essential documents required for site activation in accordance with applicable SOPs, guidelines, and relevant study-specific plans.
  • Interface with appropriate functional leads at sites to ensure timely completion of start-up activities.
  • Track timelines for study start-up through internal and external collaborations.
  • Assist sites with regulatory start-up submissions, including submissions to Institutional Review Boards and Ethics Committees, as applicable.
  • Support the development and adaptation of country and/or site-specific informed consent forms.
  • Submit all start-up related documents to the Trial Master File (TMF) or as dictated by CRO/Sponsor SOPs.
  • Maintain and perform ongoing quality review of Start-up related documents within the TMF.

Requirements

  • Minimum of 1 year of experience working in the clinical trials industry is preferred / 2-3 years of experience for Senior level.
  • Minimum of 1 year of experience working in Regulatory and/or Site/Study Startup for Senior SSU Specialist.
  • Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and required clinical study documentation, or the capacity to develop this knowledge.
  • Independent time management and ability to balance multiple priorities.
  • Aptitude for strategizing, critiquing, monitoring, planning, managing, and scheduling.
  • Demonstrated self-motivated ability to learn new software and tools rapidly.
  • Must have strong attention to detail.
  • Strong verbal and written communication skills for concise and clear presentation of information.
  • Strong customer orientation and a proven track record in working closely with others.
  • Proficiency within the MS Office Suite with applications such as Excel, Word, PowerPoint, and SharePoint.
  • Team-oriented work style that strives to give constructive guidance.
  • Strong understanding of clinical research processes, procedures, and principles.

Education

Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred. Other bachelor's degrees with relevant industry experience will be considered.

Applicants with foreign transcripts/degrees must provide a U.S. equivalency report evaluation that indicates the degree to which the foreign coursework is equivalent from one of these evaluation agencies:

Compensation

$67,000 - $90,000 annually + benefits package and annual performance bonus (Includes: health insurance, 401k retirement plan, and paid days off)

COVID-19 Vaccination: To protect the health and safety of our employees and to comply with client requirements, Vanguard Clinical may require employees in certain positions to be fully vaccinated against COVID-19, subject to reasonable accommodations or exemptions for religious, medical, or other legally protected reasons. Vaccination requirements will depend on the client site requirements. Proof of vaccination may be required, in accordance with applicable laws.

Vanguard Clinical is an equal opportunity employer for all applicants and employees. Vanguard Clinical prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

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