Sr. Cra I

1) The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

2) Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned

3) Responsible for all aspects of site management as prescribed in the project plans

4) General On-Site Monitoring Responsibilities:
5) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

6) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

7) Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review

8) Monitor data for missing or implausible data

9) Ensure the resources of the Sponsor and Covance 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 Covance travel policy

10) Ensure audit readiness at the site level

11) Travel, including air travel, may be required and is an essential function of the job.

12) Prepare accurate and timely trip reports

13) Manage small projects under direction of a Project Manager/Director as assigned a. Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned

14) Review progress of projects and initiate appropriate actions to achieve target objectives

15) Organize and make presentations at Investigator Meetings

16) Participate in the development of protocols and Case Report Forms as assigned

17) Participate in writing clinical trial reports as assigned

18) Interact with internal work groups to evaluate needs, resources and timelines

19) Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

20) Responsible for all aspects of registry management as prescribed in the project plans

21) Undertake feasibility work when requested

22) Conduct, report and follow-up on Quality Control (QC) visits when requested 23) 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.

24) Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned 25) Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

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