CRA1 Trainee Position
Company: Labcorp
Location: Dallas
Posted on: January 27, 2023
Job Description:
- Responsible for all aspects of study site monitoring including
routine monitoring and close-out of clinical sites, maintenance of
study files, conduct of pre-study and initiation visits; liaise
with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in
the project plans
- General On-Site Monitoring Responsibilities
- Ensure the study staff who will conduct the protocol have
received the proper materials and instructions to safely enter
patients into the study
- Ensure the protection of study patients by verifying that
informed consent procedures and protocol requirements are adhered
to according to the applicable regulatory requirements
- Ensure the integrity of the data submitted on Case Report Forms
(CRFs) or other data collection tools by careful source document
review. Monitor data for missing or implausible data
- Ensure the resources of the Sponsor and Labcorp Drug
Development are spent wisely by performing the required monitoring
tasks in an efficient manner, according to SOPs and established
guidelines, including managing travel expenses in an economical
fashion according to Labcorp Drug Development travel policy
- Travel, including air travel, may be required and is an
essential function of the job
- Prepare accurate and timely trip reports
- Perform CRF review, query generation and resolution against
established data review guidelines, with or without direct
supervision, on Labcorp Drug Development or client data management
systems, as assigned by management
- Assist with the administration of clinical research projects,
recruiting investigators, collecting investigator documentation and
site management
- Provide coverage for clinical contact telephone lines, as
required
- Update, track and maintain study-specific trial management
tools/systems
- Generate and track drug shipments and supplies, as needed
- Track and follow-up on serious adverse events as assigned
- Implement study-specific communication plan as assigned
- Attend investigators' meetings, project team meetings and
teleconferences, as needed
- Assist Sr. CRA in managing investigator site budgets
- Perform other duties as assigned by management
Minimum Required:
- University or college degree, or certification in a related
allied health profession from an appropriately accredited
institution (e.g. nursing licensure)and
- a minimum of 2 years of experience in a related role (e.g. site
management, in-house CRA, study coordinator, research nurse,
etc.)
- Ability to monitor study sites according to protocol monitoring
guidelines, SOPs, GCP and ICH Guidelines
Preferred:One (1) or more additional years of experience in a
related field (i.e. medical, clinical, pharmaceutical, laboratory,
research, data analysis, data management or technical writing) is
preferredLabcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion
in the workforce and does not tolerate harassment or discrimination
of any kind. We make employment decisions based on the needs of our
business and the qualifications of the individual and do not
discriminate based upon race, religion, color, national origin,
gender (including pregnancy or other medical conditions/needs),
family or parental status, marital, civil union or domestic
partnership status, sexual orientation, gender identity, gender
expression, personal appearance, age, veteran status, disability,
genetic information, or any other legally protected characteristic.
We encourage all to apply.
For more information about how we collect and store your personal
data, please see our Privacy Statement .
Keywords: Labcorp, Dallas , CRA1 Trainee Position, Other , Dallas, Texas
Didn't find what you're looking for? Search again!
Loading more jobs...