Our Client, a Research, Care and Health Financing company, is looking for a Clinical Research Coordinator (CRC) for their San Bruno¸ CA/South San Francisco, CA/Hybrid location. Responsibilities: + The Clinical Research Coordinator (CRC) will be an integral member of the growing Digital Biomarkers and Devices team (part of the Product Operations and Implementation Org), as, is seeking to improve the way clinical trials are conducted and evidence is generated using advanced software and sensor technology. + The Research Coordinator, under the oversight of the Clinical Program Manager and Principal Investigator (PI), is responsible for independently conducting clinical research sessions with study participants and execution of clinical studies that are sponsored by or an industry client. CRC conducts activities for assigned clinical research device studies including consenting participants, conducting study sessions, maintaining device accountability, and completing data entry into the Electronic Data Capture (EDC) system; maintain Investigator Site Files and support Sponsor eTMF Maintenance. + They will interact closely with a variety of teams at, as well as clients from industry. + The candidate will support digital/wearable medical device clinical research studies conducted by Clinical Development that take place at the Clinical Research Site in South San Francisco. + Work to streamline our study enrollment processes, facilitate enrollment projection rates and participant compliance strategies, and you will seek to constantly improve the quality and impact of the deliverables. You will ensure participant safety and verify diligence in protecting the confidentiality of each participant. + The Study Operations Research Coordinator shall guarantee the adequacy, reliability and quality of the data collected from internal and external sites and shall participate in the quality control processes. + The Clinical Research Coordinator will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements. + Together with researchers, clinicians, engineers, designers, advocates, and volunteers, we're collaborating to design the next generation of healthcare tools and services. As a Study Operations Research Coordinator, you will work with teams across to support clinical study enrollment implementation, and closeout to meet the needs of our internal stakeholders and clinical trial participants. + A Clinical Research Coordinator is responsible for conducting screening/enrollment visits, monitoring activities at a clinical site(s) for a clinical trial(s).You may be responsible for multiple projects and must be able to work both independently and in a team environment + Work closely with cross-functional teams for planning and execution of clinical studies to deploy Numetric Devices to support our internal Product Development + Prepare and conduct site qualification visits (pre-study visits), site initiation- and site close out visits as applicable + Manages research activities and subject participation including screening, enrollment, and recruitment. + Identifies, reviews, and reports adverse events, protocol deviations, or other unanticipated problems appropriately. + Resolves questions/issues with investigator/trial staff including query verification + Review of Trial Master File (TMF) and ensure that all documents are in order, logical, accurate, complete, up-to-date and ready for a study audit and/or inspection + Maintain and communicate enrollment projects and timelines during cross-functional project planning meetings. + Coordinate and collaborate closely with Clinical Supply, Data management, and various other teams to ensure on time launch and successful execution. + Participates in relevant study related and company-wide compliance trainings + Provide project specific training/mentoring to new team members Requirements + We are looking for an individual who is able to onboard and learn quickly, has exceptional organizational skills, is experienced in working in a range of clinical study designs, including remote/decentralized/hybrid approaches, has excellent collaboration and communication skills in a largely virtual environment. Since products include digital biomarkers, hardware sensors, software, and algorithm development, your experience in the medical devices space, will be an important aspect of the work. + Associate's degree/college Diploma/Certificate Program with 5 years of experience in clinical research/related field OR + Bachelor's degree or equivalent practical experience. + Associate's degree/college Diploma/Certificate Program with 3-5 years of experience in clinical research/related field OR + Bachelor's degree with 1-3 years of experience in clinical research + Knowledge and experience of medication device clinical trials. + Proven ability to manage multiple projects involving different devices, and in a fast-paced environment + Exceptional organizational, documentation and general clinical site management skills in a clinical trial setting; excellent communication skills, both written and verbal + Manager looking for on a resumes + Clinical research experience + Medical devices experience + Tech savvy Preferred qualifications: + Strong problem-solving and analytical skills, and ability to handle ambiguity + Ability to multi-task and prioritize to improve operational efficiency and efficacy. + Strong working knowledge of tools such as spreadsheets, Google docs, and applications, including but not limited to, use of eTMF, EDC, CTMS, site EMR systems, etc. + Ability to improvise, work efficiently and respond quickly to changes and a dynamic workflow. Why Should You Apply? + Health Benefits + Referral Program + Excellent growth and advancement opportunities As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.