Careers

Careers

ADVAGEN is a close-knit team of high-achievers who are motivated, innovative, creative and, above all else, passionate about what we do. Besides skill sets, we also look for personality.

You must thrive in a dynamic, entrepreneurial and autonomous environment where all of us work towards our common goals. You will succeed based on your contribution and work ethic. We take pride in our “family” atmosphere where each person’s contribution is vital to our success. You are empowered to make decisions, think creatively and be proactive in your approach. Positive, team-oriented people work at ADVAGEN and are rewarded with an attractive package that commensurate with your experience and most importantly a fun workplace.

ADVAGEN is an Equal Opportunity employer.

 
Opportunities:

Job listings will be updated soon. If you have any queries, please email to This email address is being protected from spambots. You need JavaScript enabled to view it.

Opportunities:

Clinical Research Associate (CRA)

The primary point of contact for investigator sites, the CRA ensures the clinical trial is being conducted according to CFR, ICH guidelines and in accordance with GCP. The successful candidate will efficiently execute monitoring and other clinical trial management activities, including tracking the progress of assigned studies/projects and proactively identifying potential challenges. You will develop appropriate actions to resolve issues and achieve target objectives, performing investigator site pre-study site qualification visits including collection of site regulatory documents.

A self-motivated individual able work in a small team environment, the CRA is a highly organized individual who can multi-task and adjust direction based on changing project/corporate priorities.  You must be flexible and willing to travel.


Primary Responsibilities:

  • Assist with site start-up activities including: site contracts and budget development/negotiation, preparation of IRB submissions (including follow through to ensure successful outcome)
  • Prepare the study reference manual, including liaising with contract research organization team (including central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites
  • Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug.
  • Participate in/Lead the Investigator/Initiation Meetings and ensure that the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in-line with protocol requirements.
  • Develop study/program plans (e.g., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)
  • Track the movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories, or movement of samples to sample management storage
  • Manage patient recruitment strategies, or pro-actively identify barriers to recruitment and propose solutions (e.g., study site webinars, newsletters, or other potential creative solutions)
  • Monitor recruitment, data quality, and patient safety while on site and remotely through EDC systems and direct site communication
  • Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
  • Maintain project files including: ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, and schedules of payment
  • Identify and complete follow- up of SAEs at study sites
  • Assist with data listing, data coding, patient profile reviews, database lock and site close-out activities
  • Ensure appropriate and timely submission of documents to the Trial Master File

Skills & Requirements:

  • BS/BA degree required
  • 1-2 years field-based monitoring, other relevant and industry experience preferred
  • Familiarity with ICH/GCP guidelines
  • Strong written and verbal communication skills
  • Strong PC skills (MS Word, MS Excel, MS Project)
  • Experience with electronic data capture (EDC) and clinical trial management (CTM) systems preferred
  • Experience with outsourced clinical trials preferred
  • Ability and willingness to travel 25-50% depending on project requirement needs

If you are interested in this opportunitiy, please email your application and resume to This email address is being protected from spambots. You need JavaScript enabled to view it.

This email address is being protected from spambots. You need JavaScript enabled to view it.

Clinical Trial Associate (CTA)