Volunteer Clinical Research Principal Investigator
ORGANIZATION: The National Alliance of Research Associates Programs
Please visit the new page to apply.
This is an unpaid virtual volunteer position. We are an all volunteer non-profit organization focused on the facilitation of clinical research. Centered in emergency deptartments across the US, NARAP is a non-profit clinical research org. facilitating large scale, national, multi-center studies to increase the quality of healthcare delivery nationally, especially in the areas of screening and prevention. Our work engages vast numbers of pre-health professional students as data collectors in the studies, providing enhanced clinical opportunities unique to the research setting while teaching the fundamentals of interacting with patients.
Principal Investigator
Reports to Director of Corporate Clinical Research
Liaisons with Corporate Clinical Research Team, NARAP Director of Affiliates
Summary:
The principal investigator is responsible for the overall conduct of clinical trials from beginning to end. This includes ensuring full regulatory compliance for documents, including clinical summaries. This position works very closely with the research team to ensure the health and welfare of study participants, in addition to being the lead author of study publications.
Essential Duties and Responsibilities :
Protecting the rights, integrity and safety and welfare of study participants and scientific research data. Also ensures that informed consent is adequately obtained according to all regulatory procedures
Confirm that he/she will be responsible for project management of the clinical trial and agree to carry out the trial in compliance with all regulations and applicable policies and procedures in order to attain the highest professional standards within the time period awarded.
Accept all of the responsibilities associated with the application for and administration of awarded sponsored clinical trials. Also assumes the responsibility to read, understand, and comply with NARAP and sponsor policies, procedures and directives for the proper administration of the sponsored clinical trial.
Provide medical and scientific feasibility of all new sponsor inquiries and/or NARAP initiated studies.
Liaise with sponsor regarding study design and site capabilities.
Interact with regulatory bodies as relevant to clinical operations and complies with all regulatory directives;
Maintain knowledge of standard operating procedures for research and perform in accordance with applicable regulatory requirements related to human research participants and HIPAA requirements.
Attend study initiation meetings. Present protocols at IRB meetings, as required. Share relevant, up-to-date knowledge with other staff, including providing in-service seminars,
Assist Clinical Operations and sales/marketing/Philanthropy with securing research funding and partnerships.
Inform IRB and Sponsor as appropriate of relevant events and /or any changes that are made to the protocol
Review and sign CRFs/eCRFs at the conclusion of the study. Delegate the above as appropriate.
Act as Principal Investigator/Co-Investigator as assigned. Weekend and off-hours work as necessary.
Takes responsibility for cooperating in the audit process, whether internal or external audit staff is involved.
Retains the primary responsibility for financial accountability. Can delegate an authorized representative to act on his or her behalf for departmental account/project management. Accounts should be managed by persons trained in these responsibilities.
Prepares the final narrative report and also submits any close out documentation needed in order to submit financial status reports on a timely basis.
Retains the scientific data in accordance with the trial regulations and the University’s Policy on Access and Retention of Data.
The Statements made in the job description are intended to describe the general nature and level of work being performed by people assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
Skills/Qualifications
Ability to read, write, and interpret the English language.
M.D. or D.O. U.S. Board Certification/DEA license Active license to practice medicine, or a PhD. 3-5 years M.D. experience in conducting clinical research.
Strong interpersonal and leadership skills, self-motivation, and high personal integrity and ethics required.
Education and Experience : Specialty in Internal Medicine, Emergency Medicine, or Family Medicine Clinical research experience within a CRO or Phase I research facility Experience conducting Phase I clinical trials.
The investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial.The medical care given to, and medical decisions made on behalf of, patients should always be the responsibility of a qualified physician.
1 More opportunity with The National Alliance of Research Associates Programs
Opportunities
About The National Alliance of Research Associates Programs
Location:
66 Lilalyn Drive, FAIRFIELD, CT 06825, US
Mission Statement
Centered in the emergency departments across the country, the National Alliance of Research Associates Programs, Inc. is a non-profit clinical research organization facilitating large scale, national, multi-center studies to increase the quality of health care delivery nationally, especially in the areas of screening and prevention. Our work engages vast numbers of pre-health professional students as data collectors in the studies, providing enhanced clinical opportunities unique to the research setting while teaching the fundamentals of interacting with patients.
Description
The National Alliance of Research Associates Programs (NARAP) tackles critical health system needs in a unique way utilizing untapped resources.
Two key endeavors, clinical research and facilitation of primary health care, markedly improve health care in the Unites States.
Think of these three big numbers: 1/2, 4, and 500,000
- More than half the U.S. population visits an emergency department as a patient or visitor each year.
- The average emergency department visit is 4 hours.
- By conservative estimate, each year more than 500,000 college students and post-baccalaureat students are "pre-med," not counting those headed to dentistry, physicians assistant, physical and occupational therapy, optometry, podiatry and other health professions.
If there were similar requirements for clinical experience for application to medical school as there are for most other health professional schools, on average 500 hours, this would result in 60,000,000 hours per year volunteered each year in activities like the RA programs. Even at minimum wage, this translates to a potential $435 million value in work by motivated, college- educated students
The National Alliance of Research Associates Programs, Inc. a 501(c)(3) designated non-profit organization, was created to bring pre-health professional students into the emergency department to serve as participant identifiers, data collectors and assistants for clinical research, particularly on studies concerning the emergency department, as a site to facilitate primary health care screening.
Our Vision is to have all emergency departments near colleges serve as a link in a national network for clinical research, a vehicle for primary health care screening and prevention, and a locus to foster the development of future health professionals. NARAP looks to change how we facilitate primary health for large segments of the U.S. population, how we conduct clinical research efficiently, rapidly and at low cost, and how we develop and select future doctors and health professionals.
CAUSE AREAS
WHEN
WHERE
This is a Virtual Opportunity with no fixed address.
DATE POSTED
January 12, 2017
SKILLS
GOOD FOR
N/A
REQUIREMENTS
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