Full-Time
Clinical Research Associate
Integrated Resources
501-1,000 employees
No salary listed
San Jose, CA, USA
In Person
Category
 Biology & Biotech (2) |
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Requirements
- Candidate with Academic Clinical Research Organization experience would also be fine, leading the study(3-4 studies)
- Understands data management and documentation process
- Candidate who has worked on clinical trials as clinical data manager, CRF design and clinical data management plan, study maintenance
- Works with Clinical Programmers, Clinical Research Associate, Statistical Programmers, Biostatisticians and other Clinical, Data Standards and Privacy Health regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
- Demonstrates a general understanding of each assigned protocol, critical tasks and milestones
- Ensure completeness, correctness and consistency of routine clinical data and data structure
- Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery
- Assists in the preparation of Case Report Forms/electronic Case Report Forms for data collection through the regulatory approval process
- Assists in implementing routine clinical research projects
- Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner
- Identifies, tracks, and resolves routine queries
- Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met
- The ability to problem solve and have people/project leadership skills
- Knowledge of Food and Drug Administration regulations, support of needs for New Drug Application and other regulatory submissions, and familiarity with web-based Electronic Data Capture and clinical data management systems
Responsibilities
- Lead the study(3-4 studies) and oversee clinical data management activities across trials.
- Oversee data management and documentation processes to ensure data quality and regulatory compliance.
- Collaborate with Clinical Programmers, Clinical Research Associates, Statistical Programmers, Biostatisticians and other Clinical, Data Standards and Privacy Health regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
- Develop and maintain general understanding of each assigned protocol, critical tasks and milestones.
- Ensure completeness, correctness and consistency of routine clinical data and data structure.
- Assist in implementing routine clinical data management processes with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
- Assist in preparing Case Report Forms and electronic Case Report Forms for data collection through the regulatory approval process.
- Assist in implementing routine clinical research projects.
- Review study protocol and assist site coordinators, investigators, and field clinical staff in collecting routine data to meet protocol requirements in a timely manner.
- Identify, track, and resolve routine queries.
- Utilize routine reports to track study progress and ensure timeliness and quality of deliverables.
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Integrated Resources, Inc.
Jan 3rd, 2024
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources, Inc.
Feb 1st, 2023
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.