Envision Research seeks a full time (100% research) Principal Investigator (PI) dedicated to the conduct and supervision of clinical trials with pharmaceutical and medical device companies in accordance with pertinent research protocols, Good Clinical Practice (GCP), and federal/state regulations. The clinical trials will be managed by Envision Research and offer the opportunity for the PI to spend ample patient-centric time with each study participant.
About Envision Research LLC
Envision Research (https://www.envisionresearch.org/), a division of BRF in North Louisiana (https://brfla.org/about/brf-board/), develops and implements strategic initiatives in clinical & translational research and pursues clinical trials with healthcare providers, start-up companies, academic medical centers and research institutions. Envision Research identifies and facilitates the initiation and conduct of Phase II to IV clinical trials by experienced research coordinators and recruitment specialists, manages all regulatory requirements, develops standard operating procedures (SOPs) and negotiates contracts and budgets with industry sponsors.
Serve as Principal Investigator on clinical trials managed by Envision Research
Guide and oversee research staff in the conduct of clinical trials, according to the study protocol and GCP
Provide training for collaborating physicians and clinic nurses on study protocol and investigational product
Delegate study responsibilities as appropriate and ensure necessary training and qualifications of clinical trial team members
Perform clinical procedures and assessments as required by the study protocol
Assist with expansion of Envision Research’s physician investigator network
Assist with patient recruitment to meet or exceed enrollment goals, and ensure patient recruitment, screening and enrollment activities are conducted according to the study protocol and GCP
Consult patient and family regarding disease under investigation and ensure understanding of experimental treatment
Ensure clinical trials are conducted according to the approved protocol, GCP, FDA/ ICH guidelines, federal and state regulations and Envision Research standard operating procedures
Adhere to HIPAA Guidelines and maintain strict confidentiality in the conduct of clinical trials
Protect patient’s rights, safety and welfare
Ensure patient’s informed consent and IRB approval of the study
Evaluate participants’ compliance with study’s medication as specified in the study protocol. Submit safety, protocol noncompliance and other reports, as required
Responsible for administration and accountability of investigational product
Provide accurate and detailed documentation per study protocol to ensure data integrity
Attend Investigator meetings, clinical research training conferences and participate in community outreach activities
Other duties as assigned.
Active M.D. or DO Licensed in Louisiana with authority for prescriptions, DEA license or ability to obtain, unrestricted ability to participate in federal programs. Prior experience as Principal Investigator in clinical trials is required.
REQUIRED KNOWLEDGE SKILLS AND ABILITIES
Leadership, excellent interpersonal and organizational skills
Adequate clinical experience as a licensed physician to ensure high quality patient care
Proficient in Microsoft Office and/or other equivalent software platform
Excellent verbal and written communication skills. Communicate effectively with sponsor representatives, community physicians, patients and family, media and Envision Research staff
Able to multitask effectively and efficiently
High degree of professionalism, self-motivation and integrity
Able to adapt to changes in responsibilities and workloads
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required for the position. Assigned responsibilities and activities may be changed as needed.
About BIOMEDICAL RES FOUND OF NW LOUISIANA
The BRF's mission is to diversify the region by promoting and developing a knowledge-based economy in northwest Louisiana. The BRF strives to generate public support and collaboration in technology-based economic development strategies, to provide infrastructure and resources to new or growing companies, and to support research at LSU Health Shreveport that may lead to marketable discoveries. In addition, the BRF promotes the development of our region's future creative workforce skilled in science, technology, engineering and mathematics (STEM) disciplines by raising private and public funds and assisting with project development for K-12 programs. - See more at: www.brfla.org or https://www.brfla.org/initiatives/orda/