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Job Opening details:-
Company Name :- Labcorp
Position Name :-
Company Location :- Dallas, TX 75206
Job Category : General jobs
Full Job Description :-
*This is a remote role, but candidates must reside anywhere in the state of Texas*
Labcorp is open to bringing on a CRA of any level of experience, CRA I to Sr. CRA II.
Required Travel: 60% (8-10 days on site a month)
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.
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
Ensure audit readiness at the site level
Travel, including air travel, may be required and is an essential function of the job.
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 and trip report review as assigned
Review progress of projects and initiate appropriate actions to achieve target objectives
Organize and make presentations at Investigator Meetings
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
Conduct, report and follow-up on Quality Control (QC) visits 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
Track and follow-up on 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
Coordinate 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
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant’s race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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