Associate Principal Investigator (Psychiatry) Opportunity in Miami, Florida!! (Physician )
Company: DOCTORS CHOICE PLACEMENT SERVICES, INC.
Location: Miami
Posted on: January 27, 2023
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Job Description:
Psychiatric-Mental Health opening in Miami, Florida. Associate
Principal Investigator (Psychiatry) Opportunity in Miami, Florida
JOB TITLE: Principal Investigator/ Sub Investigator REPORTS TO:
Associate Medical Director DEPT: Medical & Clinical JOB SUMMARY The
Principal Investigator (PI) is responsible for the oversight and
execution of Clinical Studies performed on behalf of the Sponsor.
The PI promotes Good Clinical Practices (GCP) in the conduct of
Clinical Investigations by ensuring the integrity of data generated
at the site and directing the conduct of the clinical investigation
as to the guidelines issued by State and Federal Authorities and
the Sponsor. DUTIES & ESSENTIAL JOB FUNCTIONS Provide
Qualifications & Agreements: - Will be responsible for maintaining
up-to-date curriculum vitae - Maintaining all required licenses to
practice and execute the job as PI - Providing Sponsor and IRB with
documentation of credentials as required - Demonstrating the proper
education, training and experience to conduct the clinical
investigation - Assuming the responsibility for the conduct of the
clinical investigation - Signing sponsor contract as appropriate -
Disclosing conflicts of interest as described in the regulations
Ensure Protocol Compliance: - Processing a thorough understanding
of the requirements of each protocol - Determining that
inclusion/exclusion criteria are applicable to the study population
- Ensuring recruitment goals are reasonable and attainable -
Assessing the overall protocol feasibility - Following the trial's
randomization procedures - Not implementing any protocol deviation
or changes without agreement by the sponsor and prior review and
approval by the IRB (except to eliminate immediate hazards to
subject) - Reviewing the inclusion/exclusion criteria, schedule of
visits, end point criteria and investigational article use with the
research team Ensure Initial and Ongoing Review by a Duly
Constituted IRB - Providing the IRB with adequate information to
initially review the study (i.e. protocol, investigators brochure,
informed consent forms, recruitment advertisements and any written
information to be given to subjects) - Providing the IRB with
documents for ongoing review (i.e. amendments to the protocol,
adverse events, deviations or new information) - Securing written
IRB approval prior to initiating the study or instituting any
changes to the protocol as approved - Providing written summaries
of the trial status to the IRB annually, or as requested -
Providing IRB with all documents subject to their review Determines
Adequate Resources are available to conduct study: - Having
adequate number of qualified staff to conduct the study - Having
adequate facilities to conduct the study - Ensuring he/she has
adequate time to conduct and supervise the study Manages the
Medical Care of subjects: - Having adequate number of qualified
staff to conduct the study - Having adequate facilities to conduct
the study - Ensuring he/she has adequate time to conduct and
supervise the study Manages the Medical Care of subjects: -
Ensuring that a qualified physician (Sub-Investigator) is
responsible for all trial related medical decisions - Assessing the
subject compliance with the test article and follow-up visits -
Assessing the subjects response to therapy - Evaluating for adverse
experiences - Ensuring that medical care is provided to a subject
for any adverse event - Informing subject when medical care is
needed to treat an incurrent illness - Informing the subject's
primary physician about their participation in the trial Protects
the Rights and Welfare of subjects: - Reporting serious adverse
events immediately to the sponsor and IRB - Ensuring that the
informed consent form contains all the elements required -
Obtaining a signed and dated informed consent form the subject or
subject's legal representative prior to initiating any study
related procedures - Informing the subject or legal representative
about all aspects of the clinical trial - Providing new information
about the study or rest article Ensures Validity of the Data
reported to the Sponsor: - Ensuring the accuracy, completeness,
legibility and timeliness of case report forms - Ensuring that case
report forms accurately reflect source documents - Explaining any
discrepancies between source documents and case report forms -
Endorsing changes or corrections to a case report form Ensures
Documentation of Study-Related procedures, processes and events: -
Documenting deviations from the approved protocol - Documenting and
explaining premature unblinding of the investigational product(s) -
Documenting that informed consents has been obtained from the
subject or legal representative - Ascertaining the reason for a
patients premature study withdrawal - Documenting adverse
experiences - Complying with written procedures to document changes
to data and/or case report forms - Maintaining trial documents as
required by the regulations and sponsor for the appropriate
timeframe and under secure conditions - Providing study reports as
requested by the sponsor, IRB and regulatory authority Ensure the
proper use and storage of Investigational Agents: - Being
thoroughly familiar with the use of the investigational product(s)
- Reading the current investigator's brochure, product insert or
other source information - Assuming responsibility for the
investigational product(s) at the trial site - Ensuring the proper
use and storage of the investigational product(s) at the trial site
- Assigning responsibility to the appropriate research pharmacy
personnel - Reviewing the proper use of the study article(s) Direct
Site Operations: - Communicating effectively with subjects,
research team, IRB, sponsor and or CRO - Meeting regularly with the
research team to discuss subject participation and protocol
progress - Ensuring that all research staff is informed about the
protocol and investigational agents - Being knowledgeable about
regulatory requirements and GCP standards - Preparing for and
attending investigator and start up meetings - Participating in
monitoring and auditing by the sponsor and appropriate regulatory
authorities - Making available to monitors, auditors, IRB, and
regulatory authorities requested trial related records - Delegating
authority at the site appropriately - Ensuring that all research
staff is informed about the trial related duties and functions -
Maintaining a list of qualified persons and their corresponding
trial related delegated duties Maintaining Professional and
Technical Knowledge: - Attending educational workshops - Reviewing
professional publications - Participating in professional societies
QUALIFICATIONS - Board-certified or board- eligible physician
-Clinical research experience as a principal investigator
-Excellent interpersonal skills -Excellent written and quantitative
skills
Keywords: DOCTORS CHOICE PLACEMENT SERVICES, INC., Miami , Associate Principal Investigator (Psychiatry) Opportunity in Miami, Florida!! (Physician ), Healthcare , Miami, Florida
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