Remote Trial Master File Specialist Jobs (NOW HIRING)

Employment Type:
We welcome interest from both full-time employees and independent consultants for this role. Candidates may be considered for either a permanent position or a consulting engagement based on experience, availability, and project needs.

*Applications are accepted on a rolling basis and qualified candidates will be contacted when there are new openings*

This position is available for remote work in the following states: AZ, CA, CO, FL, GA, KS, KY, MA, MD, MI, NC, NY, OH, OK, TN, TX, WA

Vanguard Clinical, Inc. is a Contract Research Organization (CRO) headquartered in San Diego, CA, USA. 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. Beginning with study development, we bring a "white glove service" approach to clinical trials. Our flexible approach and ongoing process development ensure efficiency and adequate resourcing, allowing us to respond rapidly to our clients' needs as they evolve.

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.

Position Overview:

Reporting to the Director, Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites. The Senior Clinical Research Associate (Sr. CRA) will independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs).

Essential Duties & Responsibilities:

• Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits.
• Main point of contact between assigned sites and Sponsor.
• Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements.
• Delivers high quality and timely reports following each monitoring visit.
• Completes and submits monitoring-related expense reports in accordance with the company and/or Client's travel & expense guidelines.
• Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites.
• Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites.
• Manages query resolution process with clinical sites and data management groups.
• Travel of up to 75% may be required, including globally.
• Quarterly travel to San Diego headquarters required, if not residing locally.
• Other work-related duties, special projects, and/or other functions, as required.

Experience & Skills:

• 5+ years of independent clinical monitoring experience preferred.
• Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively to meet stated internal and external commitments.
• Must exercise sound judgment and take initiative, be able to work independently with minimal supervision while producing accurate high quality and timely work.
• Must be able to work effectively within a team environment (independently and collaboratively).
• Excellent written and verbal communication skills including strong professional presentation skills (internal and external audiences).
• Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements.
• Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.).
• Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines.

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:https://www.naces.org/members.

Compensation Range:

$120,000 - 145,000 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.