100% Remote with 60% Travel
We need candidates that can accommodate a Midwest, Northeast and/or a Southeast Coast schedule to travel to clinical trial sites.
May Health, formerly AblaCare, is a clinical-stage medical device company committed to developing treatment options for women living with PCOS. The company is currently investigating its Ovarian Rebalancing™ treatment in clinical studies; Ovarian Rebalancing is a novel approach to PCOS-related fertility that has the potential to be a safe, straightforward option for activating natural ovulation. May Health is led by a team of serial medtech and women's health entrepreneurs and executives with extensive experience in product development, validation, and launch. The company has raised €10M in a Series A led by Sofinnova Partners and was founded in 2017 by the firm's medtech acceleration team, Sofinnova MD Start. May Health is headquartered in Paris, France. For more information, visit www.mayhealth.com.
Position Summary
The Clinical Research Associate is responsible for leading, assisting, and providing monitoring and site management support for clinical sites during study start-up, enrollment, maintenance, and close-out.
Responsibilities
Major Responsibilities:
- Lead or support assigned clinical trial sites(s) during start-up, ongoing activities, close-out, and reporting.
- Assist with the review of study-related and essential clinical study start-up documents including but not limited to Clinical Protocols, Informed Consent Form, Monitoring Plans, Case Report Forms (CRFs), and Site Training Materials.
- Conduct or assist in site visits including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits.
- Train study site personnel to study conduct, protocol, and database.
- Ensure sites are entering data, responding to data queries, and closing out action items in a timely fashion.
- Prepare confirmation and close-out letters and study visit reports.
- Review site essential documents to maintain high quality, audit-ready study documentation.
- Identify and escalate site issues and challenges to the study team; propose and implement solutions to prevent issues from occurring again and ensure inspection readiness.
- Suggest improvements to process, procedures and documents relating to monitoring.
- Establish and maintain relationships with investigational study sites.
Compliance & Legal Responsibilities
- Maintaining the highest standards of ethics in all circumstances
- Ensuring respect of Good Clinical Practices and General Data Protection Regulation
- Ensuring compliance with the Company quality system and all applicable guidance, standards and regulations.
Position Requirements
Necessary skills and experience:
- Minimum of 5 years of clinical site monitoring experience with regulated clinical research studies particularly during the study start-up phase and ideally involving investigational medical devices.
- Excellent planning, organizing, problem-solving, and execution skills with the ability to appropriately initiate and escalate.
- Experience coordinating, scheduling, and conducting site visits (Qualification, Initiation, Interim, and Close-Out)
- Proficient in clinical trial management and electronic data capture systems.
- Experience working in various sized organizations, including the start-up environment.
- Excellent verbal and written communication abilities, at all levels of the organization and external partners.
- Team player with a willingness to help where needed and work with a diverse team.
- Ability to travel within the United States as needed for site visits.
