Job Title:

Clinical Research Associate (CRA) – Remote (U.S.) | Women’s Health & Fertility

Location:

Remote – United States
(Must be authorized to work in the U.S.)

Department:

Clinical Operations

Job Type:

Full-Time

Important Requirement:

Must have experience in women’s health and fertility.

About the Role:

We’re looking for an experienced and driven Clinical Research Associate (CRA) to join our remote clinical team. This role focuses on supporting and monitoring clinical trials in women’s health, reproductive medicine, and fertility.
You’ll help improve care in key areas like infertility, hormonal health, endometriosis, and maternal care.
This is a remote position with domestic travel (up to 30%) for site visits.

Key Responsibilities:

Monitor Clinical Sites: Conduct site qualification, initiation, monitoring, and close-out visits.
Ensure Compliance: Follow study protocols, GCP, ICH, and FDA regulations.
Review Documentation: Check case report forms (CRFs), source data, and regulatory files for accuracy.
Act as Site Liaison: Be the main point of contact for site staff to resolve issues and answer questions.
Oversee Data Quality: Identify and address data discrepancies and deviations.
Maintain Records: Keep trial documents and reports up to date. Support reporting to project managers and sponsors.
Travel: Visit clinical sites and attend investigator meetings as needed (up to 30% domestic travel).

Qualifications:

Bachelor’s degree in life sciences, nursing, or a related field. (Master’s, RN, or NP preferred)
2–4 years of CRA experience, preferably in women’s health, OB-GYN, or fertility.
Strong understanding of clinical trials, GCP, ICH, and FDA regulations.
Excellent written and verbal communication skills.
Able to work independently in a fast-paced, remote environment.
Proficiency in tools such as Medidata Rave, Veeva, and Microsoft Office.
Experience in Phase I–IV trials is a plus.

Preferred Experience:

Background working in fertility clinics, IVF studies, or maternal-fetal medicine.
Familiarity with IRB submissions and regulatory documents specific to women’s health trials.
Clinical certifications like RN or NP are highly desirable.