Internal Medicine Physician General Internist - Physicians Only Apply - Perm - San Antonio Texas

Company: Worldwide Clinical Trials
Location: San Antonio, Texas
Posted On: 11/20/2024

A Internal Medicine Physician General Internist practice is seeking a qualified physician for San Antonio, TX. This and other physician jobs brought to you by ExactMD. Medical Doctors Only Apply.

SUMMARY: Ensures
adherence to protocol requirements, protects the rights, safety and welfare of
subjects, assures the integrity of data generated at the site and directs the
conduct of the clinical investigation according to federal and state
regulations and guidance documents. The
Associate Medical Director-Investigator works under the direct supervision and
guidance of the Medical Director. The Associate Medical Director - Investigator
indirectly supervises and oversees all clinical staff.-- --RESPONSIBILITIES:Tasks may include
but are not limited to:-------- Ensures protocol compliance:o----
Possesses a thorough knowledge and understanding
of the requirements of each protocol.o----
Determines whether
inclusion/exclusion criteria are applicable to the study population.o----
Ensures recruitment goals are
reasonable and attainable.o----
Assesses overall protocol
feasibility.o----
Follows the trial---s randomization
procedures.o----
Maintains protocol compliance and
does not implement any protocol deviation or changes without agreement by the
sponsor and prior review and approval by the IRB (except to eliminate immediate
hazards to the subject).o----
Reviews the inclusion/exclusion
criteria, procedures, scheduled visits, end point criteria and investigational
article use with the research team.-------- Supports review by a duly constituted IRB:o----
Provides the IRB with documents for
ongoing review and adequate information to review the study.o----
Secures written IRB approval prior to
initiating the study or instituting any changes to the protocol as approved.o----
Provides written summaries of the
trial status to the IRB annually, or as requested.o----
Provides the IRB with all documents
subject to their review.-------- Manages the medical care of subjects:o----
Ensures that a qualified physician is
responsible for all trial-related medical decisions.o----
Assesses subject compliance with the
test article and follow-up visits.o----
Assesses subject---s response to
therapy.o----
Evaluates for adverse experiences and
determines severity and relationship to the investigational product.o----
Ensures that medical care is provided
to a subject for any adverse event(s).-------- Protects the rights and welfare of subjects:o----
Reports all serious adverse events
immediately to the sponsor and IRB.o----
Obtains a signed and dated informed
consent from the subject or subject---s legal representative prior to initiating
any study-related procedures.o----
Informs the subject or legal
representative about all aspects of the clinical trial.o----
Always considers subject safety and
welfare the first priority.-------- Ensures validity of the data reported to sponsors:o----
Ensures the accuracy, completeness,
legibility and timeliness of case report forms.o----
Ensures that case report forms
accurately reflect source documents.o----
Explains any discrepancies between
source documents and case report forms.RESPONSIBILITIES
(Cont):o----
Endorses changes or corrections to a
case report form.o----
Reviews and signs data management
queries and case report forms in a timely manner.-------- Ensures documentation of study-related procedures,
processes, and events:o----
Documents deviations from the
approved protocol.o----
Documents and explains premature un-blinding
of the investigational product(s).o----
Documents that informed consent has
been obtained from the subject or legal representative.o----
Ascertains the reason for a subject---s
premature study withdrawal.o----
Documents adverse experiences.o----
Complies with written procedures to
document changes to data and/or case report forms.o----
Maintains trial documents as required
by regulations and sponsor for the appropriate timeframe and under secure
conditions.o----
Provides study reports as requested
by the sponsor, IRB and regulatory authority(ies).-------- Ensures the proper use and storage of investigational
agents:o----
Develops thorough knowledge and familiarity
with the use of the investigational product(s).o----
Reads the current investigator---s
brochure, product insert, or other source information.o----
Assumes responsibility for the
investigational product at the trial site.o----
Ensures the proper use and storage of
the investigational product(s) at the trial site.o----
Assigns responsibility to the
appropriate research pharmacy personnel.o----
Reviews the proper use of the study
article(s) by the subject(s).-------- Supports site operations:o----
Communicates effectively with
subjects, research team, IRB and sponsor.o----
Meets regularly with the research
team to discuss subject participation and protocol progress.o----
Ensures that all research staff are
informed about the protocol and investigational agents and are appropriately
trained in any protocol specific procedures.o----
Is knowledgeable about regulatory
requirements and GCP standards.o----
Prepares for and attends investigator
and start-up meetings.o----
Participates in monitoring visits and
audits as appropriate.o----
Permits monitoring and auditing by
the sponsor and appropriate regulatory authorities.o----
Delegates authority at the site
appropriately.o----
Ensures that all research staff are
informed about their trial-related duties and functions.-------- Maintains professional and technical knowledge:o----
Attends educational workshops and
engages in other activities to maintain continuing medical education
requirements.o----
Reviews professional publications.o----
Participates in professional
societies.------------------
Participates in Protocol Feasibility Assessmentso---- Reviews
protocol synopses and draft protocols prior to finalization to determine
feasibility, appropriateness of safety and other assessments, and amount and
level of staffing required for study execution.o---- Undertakes
research necessary to provide valuable input on protocol design based upon the
investigational product and known toxicology information.--Perform other duties as
assigned.-- The duties and
responsibilities listed above are representative of the nature and level of
work assigned and are not necessarily all-inclusive. --OTHER SKILLS AND ABILITIES: ------------------
At least 2 years experience in performing physicals, assessing and
treating patients. ------------------
Strong supervision, interpersonal and communication skills.-- ------------------
Must possess exceptional organizational and planning skills and
good documentation skills.-- ------------------
Must have good conflict resolution skills and be committed to
quality and honesty.-- ------------------
Must be punctual and have a flexible work schedule. ------------------
At least 2 years--- experience in clinical research as an
investigator or sub-Investigator.-- ------------------
In-depth knowledge of the clinical research process, including
Good Clinical Practices. ------------------
Able to make good, sound decisions under stress and time
constraints. ------------------
Possible equipment includes, but is not limited to: microscope,
computers, rolling carts, fax machines, photocopiers, telephone, lab apparatus,
mop/broom, needles, spirometry, centrifuges, and allergy testing equipment,
scales, calculators, vital signs equipment, ECG equipment, defibrillator,
suction device, pipettes, ophthalmoscope/otoscope and other medical equipment.---------------------------------------------------------------------------------------------- REQUIREMENTS:Required:---------------------- Medical
(M.D.) degree or Doctor of Osteopathy (D.O.)--Preferred:-------------------- Medical
degree plus at least 2 years of clinical research experience--Other:------------------------------------ Possible mental demands
include, but are not limited to:--
reading, math, intense concentration, verbal --communication,
written communication, client contact, and attention to detail, multiple tasks,
frequent interruptions,
fluctuation in work load.--Possible physical demands
include, but are not limited to:-- lifting
and carrying of objects weighing 5-50 lbs.,
hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking,
standing, leaning over
for extended periods of time, squatting, eye strain/fatigue, climbing, pushing,
pulling, reaching, and --exposure
risk to potentially infectious blood and/or body fluids, and/or hazardous fumes
or chemicals.-- ----Must
be able to make sound medical judgments on the health and safety of subjects during
their participation in a clinical research
study.-- Must be able to follow written
and verbal communication.-- --Must
be punctual.-- The Associate Medical
Director - Investigator will have a large amount of contact with
staff, study participants, and Sponsors.--
Professionalism will be of the utmost importance as a representative
of WCT.--




























































































































































































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