Clinical Research Associate (study monitor)
Head of Clinical Operations
820 Dubuque Avenue, South San Francisco, CA 94080 (partially remote can be considered)
Mirvie is shaping the future of pregnancy health by predicting unexpected complications before they happen for the well-being of millions of moms and babies. Complications such as preterm birth, preeclampsia and gestational diabetes, affect 1 in 5 pregnancies, with large economic costs and lifelong health consequences for mom and baby. Our ground-breaking RNA platform is first to predict unexpected complications months before symptoms appear by revealing the underlying biology of each pregnancy. This breakthrough opens a new window into pregnancy health, allowing women to act and their doctors to intervene before unexpected complications become a crisis. Detection of early disease, at the individual level, also promises more equitable care than the use of broad sociodemographic factors that often result in bias. The idea for Mirvie was sparked by the personal experience of one of the founders whose daughter was born prematurely. Our team of world-class scientists and entrepreneurs has brought to market category-first, noninvasive tests used by millions. As a women’s health organization, Mirvie’s team shares a common purpose: to create a world where every pregnancy is as healthy as possible for both mom and baby. The company is headquartered in South San Francisco, California.
The Clinical Research Associate will support Mirvie’s clinical trials and be a key member of the Clinical Operations team. This will primarily focus on conducting site visits (qualification and initiation) and remote monitoring in accordance with the study monitoring plan. Monitoring responsibilities will include: identifying and escalating protocol deviations, adverse events, noncompliance issues, and data discrepancies in order to ensure compliance with the study protocols and all applicable regulations and guidelines. This role will also support essential document collection and Trial Master File (TMF) maintenance.
Roles and Responsibilities:
- Conduct independent site monitoring visits and remote monitoring in accordance with the study Monitoring Plan to ensure compliance. Monitoring will include review of essential documents (e.g. study logs) and source documents (source worksheets and subject records).
- Meet expected timelines for completion of monitoring activities and submission of written monitoring reports
- Identify and escalate protocol deviations, discrepancies in data, and noncompliance to study protocols, applicable regulations, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs)
- Contribute to study document development, e.g. standard operating procedures, and monitoring and other study tools/worksheets.
- Identify study and personnel training needs and coordinate training as needed
- Be involved in site and study management activities including site calls and roundtables
- Effectively communicate and collaborate with external partners
- Partner with Clinical Data Management (CDM) to track clinical data entry progress and follow up on incomplete data entry and/or outstanding queries
- Ensure Trial Master File (TMF) and Investigator Site Files (ISF) are current and maintained; assist in audit readiness and preparation.
- Develop a working knowledge of maternal fetal medicine and Mirvie’s products. Understand the study protocols and accompanying background information
Qualifications and Experience:
- A Bachelor’s degree or equivalent, preferably in the life sciences or related field
- 3+ years of study monitoring (CRA) experience; prior experience utilizing technology platforms/software to perform remote monitoring is desired
- Industry experience within in vitro diagnostics (IVD) or medical device strongly preferred; prior start-up company experience is desired
- Women’s health (specifically maternal-fetal medicine) strongly preferred
- Thorough knowledge of GCP, ICH guidelines and other clinical regulatory requirements
- Working experience with a variety of electronic health record (EHR), electronic data capture (EDC) and eTMF systems
- Strong interpersonal communication (written and verbal), organizational and prioritization skills
- Ability to work independently and effectively under a fast-paced and changing environment
- Proficiency with Microsoft Office (Excel and Word) and Google Suite products
- Ability to travel on site if needed (<25%)
To apply, please send resume to: email@example.com