Spec 2, Clinical Operations, Clinical Research Associate - Onsite

MillenniumSoft Inc; Irvine (CA); On-site; USD 48,000 - 55,000; Full time

Job summary

MillenniumSoft Inc. Irvine, CA seeks a Spec 2, Clinical Operations, Clinical Research Associate with healthcare industry experience for a 12-month contract.

The role is 40 hours per week, first shift, on site with domestic travel to 3 sites per year; requires site monitoring, data collection and regulatory compliance; collaboration across Clinical Operations, Regulatory Affairs and QA.

Qualifications

• Bachelor’s Degree or equivalent in Life Sciences or Nursing.
• 3–4 years in clinical research (CRC/CRA) with healthcare industry experience.
• Experience with electronic data capture (EDC).

Responsibilities

• 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

Skills

Cross-functional collaboration

Remote monitoring

Site coordination

Data collection

Regulatory compliance

Clinical research

Electronic Data Capture (EDC)

Education

Bachelor's Degree in Life Sciences or Nursing

Tools

EDC

Job description

Position : Spec 2, Clinical Operations, Clinical Research Associate (Exp in Healthcare Industry)

Location : Irvine, CA

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client : Medical Devices Company

Job Category : Clinical

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

Range:$35-40/hr

Job Description -

Viva experience or like platform, domestic travel- 3 sites per year . Clinical research experience , Data collections | on site -4days Friday flexible.

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)