DotLab is seeking a Clinical Research Associate to join our team and support DotLab clinical trials. This role will initially focus on conducting remote site visits including monitoring of study data in accordance with the study monitoring plan. This role is also responsible for identifying and escalating protocol deviations, adverse events, noncompliance issues, and data discrepancies in order to ensure compliance with the study protocols and all applicable regulatory frameworks. In the future, this role may support day-to-day execution of additional clinical trials.

This position will require experience working in a fast-paced environment. The candidate will have the ability to work in ambiguity, to be proactive in seeking and utilizing available resources to effectively problem solve, to be flexible and creative while ensuring the clinical trials are executed in compliance with regulatory quality requirements, and identifying areas of improvement to drive efficiency within Clinical Operations.

Responsibilities:

• Conduct independent site monitoring visits and remote monitoring in accordance with the study Monitoring Plan to ensure compliance with the Protocol, applicable regulatory standards, IRB policies, and DotLab policies and procedures. 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. Propose solutions and collaborate with site personnel and DotLab study team towards securing site compliance.
• Contribute to study document development, e.g. standard operating procedures, and monitoring and other study tools/worksheets.
• Identify study and personnel training needs and work with the DotLab study team to facilitate solutions.
• Effectively communicate and collaborate with external partners
• Monitor 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 endometriosis and DotLab products. Understand the study protocols and accompanying background information

Requirements:

• A Bachelor’s degree or equivalent in the life sciences or related field required.
• 2+ years of study monitoring (CRA) experience; 1+ years of study monitoring combined with CRA certification can be considered
• Industry experience within in vitro diagnostics (IVD) highly preferred; biologics or medical device experience also acceptable
• Familiarity with medical terminology and ability to review detailed medical records and reports is required; Previous women’s health experience is preferred
• Thorough knowledge of GCP, ICH guidelines and other clinical regulatory requirements
• Working experience with an electronic data capture (EDC) system and eTMF system
• Strong interpersonal communication (written and verbal), organizational and prioritization skills
• Ability to work independently and effectively under a fast-paced and changing environment
• Strong work ethic and demonstrated ability to deliver assignments on time
• Proficient with office automation tools, such as the Google suite of apps and Microsoft Office