Clinical Regulatory Assistant

CRA’s mission is to help bridge the healthcare gap in underserved communities by providing equitable opportunities and access to cutting-edge treatments and clinical trials. CRA brings hospitals, physicians, patients, and pharmaceutical companies together, providing the infrastructure needed to conduct clinical trials within the patient’s own community. Our network of community-based hospitals and physician practices spans the New York metro area.

Join us in building a healthier, more inclusive world where state-of-the-art treatments are accessible to all, regardless of ethnicity, financial position, background or location.

Regulatory Assistant

: Full Time

· Maintain patient research charts (digital and hard copy).

· Create new patient research charts (digital and hard copy).

· Prepare documentation for review by Sponsor/CRO during monitoring visits and quality checks.

· Complete uploads of patient scans to imaging platforms (Clario, Ambra, Caylx, QMS, URG) and answer associated queries.

· Request medical records when needed.

· Handle and pack investigational product and supplemental drug for delivery to treatment sites.

· Achieve understanding of schedule of assessments for each protocol.

· Handle outreach and scheduling for CRA/Principal Investigator calls with Sponsors/CROs and vendors.

· Maintain CRA calendar, provide a month-at-glance print-out to team, keep team apprised of scheduling conflicts.

· Manage off-site storage, package / box records by study, complete requisition forms.

· Maintain company Sharepoint, upload updated protocols, informed consents, pharmacy manuals.

· Complete tasks within deadlines.

:

· Bachelor’s degree in health-related field/sciences, preferred.

· Prior regulatory experience preferred.

· Hazardous drug handling experience preferred.

· Proficiency in Microsoft Word, Excel, PowerPoint.

· Skills: Detail-oriented, highly organized, effective communicator, critical thinker.

: Monday through Friday, day shift, onsite in office environment. This position will be based in the Corporate Office in Westbury, NY.

:

· Medical insurance

· Dental insurance

· Vision insurance

· Paid time off

Job Type: Full-time

Pay: $50,000.00 - $70,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to Commute:

• Westbury, NY 11590 (Required)

Ability to Relocate:

• Westbury, NY 11590: Relocate before starting work (Required)

Work Location: In person

Salary : $50,000 - $70,000