Clinical Trial Assistant 2 (New Markets) at Dexcom in San Diego, California

Job Description:

About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Summary:

This position is responsible for coordinating the in-house operational aspects of clinical studies and processing of data generated during clinical studies. S/he will work closely with Clinical Affairs and New Markets management, CRAs, relevant internal Dexcom functional groups and study coordinators to process the flow of data between a study site, including internal studies, Clinical Affairs, and New Markets; and assure that the operational and regulatory aspects of the Clinical Affairs and New Markets departments are met. Works with various functional groups such as R&D, Biostatistics, Finance, Legal, Marketing, Quality Assurance, and Operations.

Functional Description: Support Individual Contributor

Work with the Clinical Research Associates to coordinate specific and detailed activities related to one or more clinical trials/projects. Manage the required documentation to support the trials/projects. Schedule meetings, take meeting minutes, oversight of data collection and other trial/project materials.

Essential Duties and Responsibilities:

• Assists with the management of studies by coordinating daily operations including methods, workflow and implementation of procedures.


• Serves as quality control for study-related documents and be accountable for their correct distribution.


• May work with management and CRAs to prepare detailed reports surrounding study, study progress, and findings.


• Assists management and CRA personnel to develop and execute clinical trial contracts & budgets.


• Provides input for department's finances.


• Maintains organization, preparation and ordering of supplies and equipment required for clinical studies.


• Processes timely shipping of clinical study supplies and equipment.


• Initiates distribution of all regulatory documents, clinical trial research agreements, investigator's clinical agreements to Investigators.


• Maintains a tracking mechanism for regulatory documents for any regulatory submission (FDA or other regulatory body).


• May coordinate preparation of key documents for trial site submission to IRBs.


• Creates and maintain tracking mechanisms for all study-related documents, activities and projects through all phases of the study.


• Provides support to CRA personnel for preparing documentation, reports, and presentations.


• May work with Manager, Legal, and site personnel to generate Non-Disclosure Agreements and Clinical Study Agreements for potential sites.


• May assist with clinicaltrial.gov submissions.


• May participate in collection of clinical trial data needed for clinical trial insurance renewal for Finance group.


• Coordinates study-related meetings, as needed. Performs scribe function during clinical meetings and produces meeting minutes for management review.


• Assists management with departmental audits of clinical studies and procedures.


• Creates CO documents in company's document control system.


• Creates PO requisitions per managements direction into company's financial system.


• Processes site payment processing through Finance department.


• Create customized payment schedules based on milestone events.


• Monitors all payments issued to clinical trial sites on spreadsheet.


• Compiles fiscal accounting to Clinical Affairs management as needed.


• May maintain contracts including scope, content and payment terms with consultants and other third parties.


• Works independently to manage assigned clinical tasks and deliverables to meet clinical timelines.


• Collaborates effectively with peers and leadership across departments.


• This position assumes and performs other duties as assigned.

Required Qualifications:

• Possesses strong computer skills, including proficiency with Word, Excel, Access, Outlook, and/or PowerPoint, or ability to quickly learn applicable software programs.


• May be required to learn more complex computer programs, such as Oracle, GoToMeeting, or other web-based meeting and download software.

Preferred Qualifications:

• Clinical Trial Management System (CTMS) experience


• Experience with clinical trials in the therapeutic area of Diabetes


• Current GCP (Good Clinical Practice) Training

Travel Required:

• None

Experience and Education Requirements:

• Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent.

Functional/Business Knowledge:

• Moderate understanding of general job aspects and some understanding of the detailed aspects of the job.


• Applies acquired job and company knowledge of policies and procedures to complete semi-routine tasks.

Scope:

• Work at this level requires following standardized methods and under immediate supervision on assignments that are semi-routine in nature.


• Follows pre-established guidelines and procedures with minimal choice as to method of performance of the work.


• Has contact with employees at other levels within the company. Information exchanged is generally noncomplex.

Judgement:

• Normally follows established procedures on routine work, requires instructions only on new assignments.


• Works under close supervision.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.