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Clinical Research Associate 2 or Sr. CRA - Central or West Coast US

Employer
Labcorp Drug Development - USA
Location
Dallas, Texas, United States
Salary
Competitive
Start date
8 Jan 2023
Closing date
2 Feb 2023

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Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Labcorp is Hiring CRAs!! Remote based in the Central & Western US, Regional Travel!

Are you ready to redefine what’s possible, and discover your extraordinary potential at Labcorp? A career here provides the unique chance to create a lasting impact and difference in our patient’s lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Our mission is to help our clients bring the miracles of medicine to market sooner

Join us for your next career move!!

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 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 travel policy
  • Prepare accurate and timely trip reports
  • Manage small projects under direction of a Project Manager/Director as assigned
  • Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Organize and make presentations at Investigator Meetings
  • Report, write narratives and follow-up on serious adverse experiences
  • Participate in the development of protocols and Case Report Forms as assigned
  • Participate in writing clinical trial reports as assigned
  • Interact with internal work groups to evaluate needs, resources and timelines
  • Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
  • Responsible for all aspects of registry management as prescribed in the project plans
  • Undertake feasibility work when requested
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
  • Negotiate study budgets with potential investigators and assist the Labcorp legal department with statements of agreements as assigned
  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp or client data management systems as assigned by management
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring
  • Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
  • Perform other duties as assigned by management


Required Experience:
  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
  • In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered


Minimum Required:
  • Advanced site monitoring skills
  • Advanced study site management skills
  • Advanced registry administration skills
  • Ability to work with minimal supervision
  • Good planning and organization skills
  • Good computer skills with good working knowledge of a range of computer packages
  • Advanced verbal and written communication skills
  • Ability to train and supervise junior staff
  • Ability to resolve project-related problems and prioritizes workload for self and team
  • Ability to work within a project team
  • Works efficiently and effectively in a matrix environment
  • Valid Driver’s License
  • Independent, onsite monitoring experience


Labcorp is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

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

 

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