Clinical Research – Sub InvestigatorApply
- Company: Circuit Clinical
- Posted: 04/01/2021
- Location: Buffalo, NY
- Category: Professional
- Job Type: Direct Placement
Who we are:
Since 2015, we have been on mission to transform the way people find, choose, and participate in clinical research by building one of the largest integrated research organizations in the U.S and by creating our award winning technology TrialScout, the first ever patient rating and review platform for clinical trials. Our technology isn’t the only award winner! As a winner of the 2020 Best Places to Work contest by the Buffalo Business First periodical, we work hard to make sure our culture is focused around transparency, accountability, performance, and continuous learning – because just as we are obsessed with the patient experience in clinical trials, we are equally obsessed with the employee experience. We are looking to expand our growing team!
What we offer:
We are proud to offer competitive benefits, salary, and an environment focused on helping you grow personally and professionally.
What you’ll do:
The Sub Investigator works closely with the Principal Investigator to oversee the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and other state and local regulations as applicable.
You’ll be responsible to:
- Serve as a sub-investigator on active clinical trials and biospecimen projects in order to provide additional support to the Physician Investigator and clinical research staff
- Perform all job responsibilities in accordance with standards of Good Clinical Practice
- Delegate study responsibilities as appropriate to trained study staff
- Possess a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures
- Review Investigator’s Brochure & study protocol prior to performing any study related activities and attend necessary training
- Ensure informed consent has been obtained prior to performing any study procedures
- Perform all study responsibilities in compliance with the IRB approved protocol
- Review screening documentation and approve subjects for admission to study
- Review admission documentation and approves subject for randomization
- Document all findings in subject-specific source documents
- Provide ongoing assessment of the study subject/patient to identify Adverse Events
- Ensure proper documentation and reporting of all Adverse Events and Serious Adverse Events
- Review and evaluates all study data and comments to the clinical significance of any out of range results
- Perform various physical examinations, including pelvic exams, as part of screening evaluation and active study conduct
- Provide medical management of adverse events as appropriate
- Complete all study documentation in accordance with the study-specific requirements
- Communicate with Sponsors and auditors as requested
- Assist with onboarding new clinical trials from initial trial review and PI selection through feasibility completion, budget development, patient identification and recruitment
Who you are:
- You have a patient first mentality
- You are warm and empathetic
- You are able to take concepts of clinical studies and describe it in a way a lay person can understand
- You have a well rounded medical background and have proficiency with examination skills
- You have a continuous learning mindset and love putting your science hat on
- You like the fine print
- You have good relationships with your medical peers
- You like teaching others
- You are able to identify problems and escalate issues quickly
- Your documentation skills are stellar
- MD, NP, or PA-C licensed and registered in the state of New York
Your preferred experience:
- 5+ years experience in primary care or hospital setting, exposure to multiple therapeutic areas
- Clinical Research and leadership experience preferred
- Knowledge of CTMS a plus
- Proficient with Microsoft office and G-suite
- Knowledge of project management preferred
- Spanish speaking a plus
Who you’ll report to:
Reporting to the SVP of Operations, you’ll work closely with the Clinical Operations and Business Development groups.
The other fine print:
- Location: This position is located in Buffalo, NY
- Travel: May require regular travel to potential sponsor and research site locations
- Exemption status: Full time, exempt
- Physical requirements: the following physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:
- Regularly required to stand; walk; use hands; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear.
- Occasionally required to sit.
- Occasionally lift and/or move up to 50 pounds.
- Specific vision abilities include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.