Direct point of contact performing clinical trial monitoring and clinical site management for our clients; ensuring overall integrity of clinical study implementation and adherence to clinical study protocol at clinical sites.
You know how to balance strong people skills with a very detail-oriented checklist mentality and “quality” could be a tattoo for you.
You have the road warrior thing nailed and enjoy the flexibility to work from home when you can
Good Clinical Practice/ICH Guidelines, Good Laboratory Practices and HIPAA requirements are music to your ears, not swear words.
An on-site visit revealed some issues – no problem; you have the charm & negotiation skills to turn it around and get that investigator to do something he/she doesn’t want to.
You use good judgement to ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
You want to be a part of a company that is passionate about helping patients receive expanded treatment options by getting the new products to market as well as the camaraderie of working with teams that share that passion.
Essential duties include but are not limited to:
Manage and maintain clinical trial sites including consideration of investigator, selection, analysis of potential recruitment, and preparation of trial related documentation
Plan the requirements for clinical trial sites participation, order clinical trial supplies and materials, set up and monitor the systems whereby the assigned staff can ship clinical trial materials and supplies to the investigator, maintain procedures to account for the clinical trial material
Conduct investigator’s start-up meetings and study site initiation visits, routine monitoring visits and other necessary meetings
Participate in planning and project meetings, provide updates direct to clients for assigned sites
Be the first point of contact when investigators/site personnel inquire about patient inclusion/exclusion criteria for ongoing trials and any other relevant project items, maintain full site management
Along with the Project Management Team, ensure procedures are in place to manage patient recruitment strategies to increase patient enrollment into the trial (e.g., investigator and research nurse meetings, update newsletters, advertising, letters to GPs)
Review all adverse and serious adverse events and ensure events are routed through the established and proper study specific procedure from event onset to closure. Ensure sites are notified as appropriate and that all project established procedures are complied with
Help to organize Ethics/IRB committee submissions with follow through to ensure successful outcome
80% travel expected and perform onsite monitoring visits, with short notice, due to nature of trials
Bachelor’s degree or equivalent experience in healthcare
Minimum of 3 years field monitoring experience that includes some experience with IVD research studies
Travel enabled (80%)
Travel enabled on short notice
Good Clinical Practice/ICH Guidelines, Good Laboratory Practice and HIPAA
Must be able to read, write, speak fluently and comprehend English language
In this key job, you will receive a range of benefits from Precision, including competitive compensation; immediate medical, dental, and vision benefits; a 401(k) savings plan with an immediately vested company match; a generous paid time off policy, adoption assistance, educational assistance, company-paid life insurance, and more.