Currently 3 openings.
The incumbent will have the overall management and study site monitoring of clinical sites, which include conduct of pre-study and initiation visits, interim monitoring, and close out visits in accordance with company standard operating procedures. The incumbent will also have on and off-site monitoring responsibilities that include ensuring study staff has received proper training to conduct the study according to the protocol and applicable regulations; as well as maintaining protection of study patients by verify that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements, including VICH-GCP guidelines. The incumbent will prepare accurate and timely monitoring trip reports, review progress of projects and initiate appropriate actions to achieve target objectives, and organize and present at investigator meetings. The incumbent will participate in the development of protocols and CRF/EDC as assigned, including writing clinical trial reports and interact with internal work groups to evaluate needs, resources, and timelines. Additional responsibilities include recruitment of potential investigators, preparation of submissions, preparation of study related documentation, and organization of meetings as well as other tasks as instructed by supervisor.
Qualification requirements include a university/college degree (life science preferred) or certification in a related allied health profession from an accredited institution (e.g. nursing, laboratory, medical/technical). Experience required includes a minimum of two (2) years of animal health clinical research monitoring experience (including pre-study, initiation, interim monitoring, and closeout visits). In lieu of the previous requirements, candidates with > four (4) years supervisory experience in a health care setting or > three (3) years clinical research experience in the human pharmaceutical or CRO industries (including monitoring) may be considered. An average of 50-60% of travel is required.
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