Jobs

Description

Manager's Update:

This is a PART TIME 25 hours per month role | Initially this candidate would involve 30-35 hours per week but after that it would straight away cutting down to 25 hours per week

This is a 100% remote role

Candidate can work anywhere from the United States (They can work as per their time zones)

• No Physical travel is involved in this role
• There is no such overqualification criteria involved in this role (In-terms of education & exp.)
• Must have minimum of BS degree
• Must have exp. with Clinical Management
• Exp. with Veeva would be nice to have
• Must have GCP knowledge
• Must have prior medical device industry exp.
• What kind of study are they focusing? - NSR (Non- significant Risk)
• This person will be involving in Blood pressure monitoring
• Must have minimum of 2+ years of medical device industry exp.
• Must have clinical study exp.
• Must be familiar with Study close out and start-up
• Must have remote monitoring exp.
• Must have exp. with EDC (Electronic Data Capture)

Role Purpose

• Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

Essential Job Functions

• Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout
• Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).
• Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan
• Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel
• Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance.
• Assist with any site remediation activities, as applicable
• Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training
• Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas

Required

• Bachelor's Degree or Equivalent Life Sciences or Nursing
• 3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry
• Experience with electronic data capture.

Preferred

• Licenses and Certifications: Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)