Associate Science Jobs in Kansas (NOW HIRING)

Job Summary and Purpose:

The Senior Monitor will be responsible for actively monitoring multiple clinical sites independently while overseeing and mentoring junior monitors. This role requires extensive experience in clinical trial monitoring, as well as the ability to manage smaller pilot studies autonomously. The Senior Monitor will also play a critical role in working with CROs to ensure seamless monitoring during pivotal phase field trials. Additional responsibilities include ensuring laboratory and clinical activities are performed in compliance with current scientific knowledge, quality and regulatory requirements and supporting other departments for technical processes and organization.

Responsibilities and Key Duties:

Clinical

        Organize, coordinate and lead the execution of pivotal and non-pivotal clinical studies

        Recruitment of clinical investigative sites

        Design electronic data capture (EDC) system to ensure high-quality trial data collection.

        May act as a study monitor

        Select and train clinical monitoring team (including CROs and laboratories if necessary) and implement adequate meetings while in life phase of pivotal studies are ongoing. Ensure monitoring team as well as clinical investigative sites remain compliant with study protocols and regulatory requirements.

        Support regulatory department in submission of documents/requests to FDA/CVM (including H-submissions, meeting requests, protocol submissions, SAE reporting, etc.)

Communication

        Independently source supplies in support of clinical studies.

        Interacts with external collaborators

        Maintain regular inter and intradepartmental communication in support of ongoing projects

        Present scientific literature for internal review

Scientific Writing/presentation

        Maintain high quality regulatory documentation

        Author and edit a variety of study documents, including, but not limited to, study protocol, protocol amendments, monitoring manual, data management plan, SOPs, training decks, etc.

        Review technical documents for accuracy of timelines, methods, and data sets

        Prepare presentation using Microsoft Powerpoint for internal sharing of data

Core Competencies:

       Shape solutions out of complexity - Is open and curious of others perspectives

       Client focus - Has in mind clients satisfaction

       Collaborate with empathy - Has a positive attitude towards collaboration

       Engage and develop - Clarifies short-term directions

       Drive ambition and accountability - Proactively manages own and others work

       Influence others - Communicates transparently

Technical / Functional Competencies:

        Expertise in clinical study design, EDC systems, GCP/VICH guidelines and regulatory compliance

        Ability to clearly and accurately write and present scientific information

        Ability to work in a team setting

        Proven ability to manage multi-site studies and oversee clinical monitoring staff

        Prior experience interfacing with CROs to ensure high-quality clinical monitoring performance

        Excellent problem-solving, leadership and communication skills

        Ability to travel as needed for site visits and regulatory meetings

Qualifications:

Education - BA/BS in Microbiology, Biology, or related field

Work Experience - 5+ years of relevant experience, or a graduate degree (MS or PhD) in a related field

Physical Requirements:

        Ability to read, write legibly, and communicate in English

Working Conditions:

        Ability to coordinate with multiple different departments across multiple time zones to ensure work is completed on time and with high levels of execution.

Travel Required:

        25%

This This job description isintended to convey information essential to understanding the scope of the joband general nature and level of work performed by job holders within thisjob.  This job description is not intendedto be an exhaustive list of qualifications, skills, duties and responsibilitiesor working conditions associated with the job.  This job description is not an employment contract.  Ceva reserves the right to modify job dutiesand/or job descriptions at any time to meet the needs of the business.

*VEVRAA FederalContractor
**Ceva is an equal opportunityemployer and all qualified applicants will be considered for employment withoutregard to race, color, religion, sex, national origin, age, geneticinformation, actual or perceived sexual orientation, gender identity, disabilitystatus, protected veteran status, or any other characteristic protected bylaw. Ceva encourages men and women, members of all racial and ethnic groups,individuals with disabilities and veterans to apply.
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