- Responsible for supporting external, internal, decentralized, and virtual clinical trials and registries.
- Supporting operational aspects of clinical trials, including the development of study and source materials (SOPs, IRB forms, etc.).
- Supporting internal departmental quality compliance.
- Contribute to the development, implementation, execution, and follow-up of clinical research and development activities to meet business goals and objectives.
- Coordinate multiple ongoing clinical research studies.
- Responsible for ordering and tracking of study supplies and device provisioning for multiple clinical studies.
- Work closely with the Customer Support and Product/Engineering teams to track reported issues to ensure follow-up and regular communication with the study sponsor/site staff.
- Work closely with the Data Science team to ensure the quality of clinical trials and data analysis.
- Assist with the development and maintenance of training materials in collaboration with Customer Support and Marketing.
- Ensure compliance with SOPs and regulatory requirements (e.g., GCP and US and OUS guidelines).
- Participate in project and departmental team meetings.
- Track and record safety concerns and adverse events/SAEs.
- Participate in product improvement activities (information gathering, requirements, cross-functional meetings) that meet our customers' needs.
- Understand diabetes and comorbid conditions.
- Special projects as assigned
- Excited to work on a team that cares deeply about helping those living with chronic conditions.
- Bachelor's degree or equivalent in a related field with 1-2 years of experience in clinical trials.
- Knowledge of digital health solutions and applications is preferred.
- Knowledge of the clinical research process is preferred.
- Excellent organization and customer service skills.
- Possess problem-solving skills, attention to detail, and resourcefulness; respect and responsibility are critical to success in this role.
- Able to work independently to manage clinical tasks and deliverables to meet timelines with a customer service orientation.
- Strong interpersonal and communication skills across all levels of the organization.
- Ability to collaborate cross-functionally with internal and external key stakeholders, including the clinical studies team, data management, clinical site investigators, global clinical, and other internal customers.
- Commitment to individual and team success.
- Is responsive and approaches work with a bias for action. Will thrive in a fast-paced, changing environment with limited structure that requires flexibility, resourcefulness, efficiency, and communicates effectively in a remote environment.
- Knowledge of type 1 diabetes and cardiometabolic diseases preferred.
- Travel for customer meetings and conferences may be required for up to 10%.
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Clinical Trial Associate - Remote, United States - Glooko
Description
Report: This position reports to the Director, Clinical Research and Evidence Generation.
Job Summary:
The Clinical Trial Associate (CTA) plays a key role in supporting Glooko's Clinical Research projects. This role will be a good fit for candidates who desire to learn and grow professionally while gaining experience in clinical trial management. The CTA will assist with existing clinical projects and management of accounts/clinical studies, using knowledge of Glooko products and managing individual projects. This includes managing clinical/outcomes research projects to ensure Clinical Research opportunities are executed and set up for success.
Areas of Responsibility:
Core Responsibilities:
Qualifications and Requirements:
The Company:
Each year, diabetes, obesity, and other cardiometabolic diseases cause the highest incidence of death, disability, and healthcare system costs. At Glooko, we make it simpler for people with these illnesses to connect with their physicians and care teams. Glooko is the universal platform for providing an FDA-cleared, HIPAA-compliant, EU MDR-certified Web and Mobile (iOS and Android) application for people with clinicians who treat them.
Glooko accelerates research and improves care by making it simpler for people to collect and share their health data with physicians and researchers. The platform seamlessly unifies and visualizes data from over 210 devices, including blood glucose meters, insulin pumps, continuous glucose monitors, activity trackers, and biometric devices. Connecting to these devices allows Glooko to deliver insights that improve personal and clinical decision support. Patients and providers have one place to view their health management information, including medications, food intake, exercise, and biometrics. The platform makes it easier for physicians to monitor and deliver more personalized care remotely.
Glooko's mobile app and web dashboard enable patients to track and proactively manage their diabetes care easily. Glooko's Population Tracker and APIs offer diabetes-centric analytics and insightful reports that enable clinicians to identify at-risk patients. Clinicians can send pattern-triggered notifications to patients, health systems, and payers.
Our proprietary platforms enable clinical trial conduct and acceleration by leveraging advanced patient selection and site identification tools as well as remote device and e-PRO data collection capabilities. This platform's capabilities support the rapid development and iteration of digital companion and therapeutic applications.
Launched in 2010, Glooko is funded and managed by visionary technologists and leaders in healthcare.
Glooko provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, or disability. In addition to federal law requirements, Glooko complies with applicable state and local laws governing nondiscrimination in employment in every location where the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Posted positions are not open to third-party recruiters/agencies, and unsolicited resume submissions will be considered free referrals.
***NOTE: Only the job postings listed below are legitimate Glooko, Inc. job postings. All current job postings are listed on , LinkedIn, Indeed, and Glassdoor under "Glooko." Any domain that links to this page that references a position not listed here is not a legitimate Glooko job posting.
