This job has expired

Clinical Research Associate II (Dallas, TX)

Employer
Labcorp Drug Development - USA
Location
Dallas, Texas, United States
Salary
Competitive
Start date
17 Jan 2023
Closing date
27 Jan 2023

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
You need to sign in or create an account to save a job.

Job Details

Phase I

Regional Travel - up to 80% in DALLAS!

Essential Job Duties
  • 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 6 months of experience in a related role
  • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines


Preferred:

One (1) or more additional years of experience with Phase 1 studies (as a Clinical Research Coordinator or as a CRA).

Labcorp 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 .

Company

Labcorp Drug Development, a leading contract research organization (CRO), is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

Together with our clients, we support the development of innovative, life-changing treatments. We look to the future and work tirelessly to test new drugs, treatments and therapies. Labcorp supports clinical trial activity in approximately 100 countries, generating more safety and efficacy data to support drug approvals than any other company.

From our Chairman and CEO – Adam Schechter

Adam Schechter

 

Marcys career journey

video-labcorp

In Pursuit of Answers

Find Us
Website
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert