Senior Clinical Research Associate
Company: Tigermed America
Location: Houston
Posted on: January 27, 2023
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Job Description:
Job DescriptionAn opening has become available for a SCRA or CRA
to join one of the fastest growing CROs. We are currently looking
for a(Senior) Clinical Research Associateto join us. This position
is permanent, home-based, can be located nationwide.Senior Clinical
Research Associate Job Description:As Clinical Research Associate
you will be responsible for monitoring clinical trials and ensuring
investigators are conducting the research within requirements of
the clinical protocol. You will also make sure that: Research is
conducted in accordance with applicable federal regulations / FDA
guidelines Data quality on initial review meets acceptable clinical
standards Rights and safety of human subjects involved in a
clinical study are protected.Responsibilities:Further
responsibilities of this Clinical Research Associate position
include: Participates in the investigator recruitment process.
Performs initial qualification visits of potential investigators.
Evaluates the capability of the site to successfully manage and
conduct the clinical study, both clinically and technically. Works
with the Study Start-up Group to coordinate activities with the
site in preparation for the initiation of studies. Obtains
regulatory documentation for successful implementation, monitoring,
and evaluation of clinical trials. Works with Study Start-up Group
and site staff to obtain regulatory (IRB/EC) approval of study
specific documents. Performs study initiation activities, reviewing
with the site personnel the protocol, regulatory issues, study
procedures, and provides training on completion of the eCRF;
monitoring activities and study close-out activities. Trains site
staff on the EDC system and verifies site computer system. Conducts
periodic site file audits to ensure compliance with GCPs and
companys standard operating procedures. Assures adherence to Good
Clinical Practices, investigator integrity, and compliance with all
study procedures through on-site monitoring visits. Performs
validation of source documentation as required by sponsor. Prepares
monitoring reports and letters in a timely manner using approved
company /sponsor forms and reports. Documents accountability,
stability and storage conditions of clinical trial materials as
required by sponsor. Performs investigational product inventory.
Ensures return of unused materials to designated location or
verifies destruction as required. Reviews the quality and integrity
of the clinical data through (1) in house review of electronic CRF
data and (2) on-site source verification. Works with sites to
resolve data queries. Reviews protocols, eCRFs, study manuals and
other related documents, as requested by Clinical Trial Manager.
Serves as primary contact between the company and investigator;
coordinates all correspondence; ensures timely transmission of
clinical data with the study site and technical reporting, as
requested. Assists with final data review and query resolution
through database lock. Performs study close-out visits. Assists
with, and attends, Investigator Meetings for assigned studies. May
serve as mentor for new clinical study monitors. Authorized to
request site audits for reasons of validity.Qualifications, Skills
and Experience:To be considered for this Clinical Research
Associate you will have the following qualifications, skills and
experience: Knowledge of clinical research process and medical
terminology. Proven experience in monitoring and/or coordinating
clinical trials preferred; experience in a clinical setting a plus.
Strong written and verbal communication skills to express complex
ideas to study personnel at research and clinical institutions.
Strong organizational and interpersonal skills. Ability to reason
independently and recommend specific solutions in clinical
settings. Able to mentor entry level CRAs. Understand electronic
data capture including basic data processing functions. Understand
current GCP/ICH guidelines applicable to the conduct of clinical
research Able to qualify for a major credit card. Valid drivers
license; ability to rent automobile. Willingness and ability to
travel domestically and internationally, as required. BS/BA in one
of the life sciences with proven experience of field monitoring
experience. Computer literacy and knowledge of electronic data
capture preferred. Must be able to travel domestically and
internationally approximately 50%-75%. Language: English(required)
Work authorization: United States(required)We are an equal
opportunity employer and value diversityHow to Apply:Please send
your resume to Thomas at zhengze.xiang@tigermedgrp.com. Please
refer to CRA application in the email subject in all
correspondence. We will only review CVs sent to the above email
address.by Jobble
Keywords: Tigermed America, Houston , Senior Clinical Research Associate, Other , Houston, Texas
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