Clinical Research Associate

APR Consulting, Inc. has been engaged to identify a Clinical Research Associate
 
Location: New Haven, CT 06510
Position: Clinical Research Associate
Pay Rate: $80.50/hr
Duration: 26 weeks
Expected Shift: 40 hrs/week
8am to 5pm
 
POSITION TYPE:
Primarily Onsite with Remote Monitoring Activities
 
SCHEDULE:
Part-Time | Flexible Scheduling
 
CONTRACT TYPE:
Contract (6–10 Months) | Potential Temp-to-Perm
 
START DATE:
ASAP
 
IMPORTANT CALL OUTS:
Independent monitoring experience required
Approximately 8–10 monitoring visits per quarter
Flexible scheduling with advance notice provided for monitoring visits
Onsite monitoring visits estimated at 6–8 hours each
Remote monitoring visits estimated at 4–6 hours each
Neuroscience/Neurology experience preferred
Imaging research experience preferred
Potential for additional study volume as new studies are added
Potential temp-to-perm opportunity
Required Qualifications
 
EDUCATION:
Bachelor's degree in Life Sciences, Healthcare, Nursing, Public Health, or related field required.
 
EXPERIENCE:
Minimum three (3) years of clinical research monitoring experience
Experience independently conducting monitoring activities
Experience supporting Phase I and/or Phase II clinical trials
Experience reviewing source documentation, regulatory documentation, and study records
Experience working with sponsors, investigators, and research sites
 
CERTIFICATIONS:
ACRP, CCRP, SOCRA, or equivalent certification preferred
GCP certification preferred
 
TECHNICAL SKILLS:
Electronic Data Capture (EDC)
Trial Master File (TMF)
Clinical trial monitoring
Source data verification (SDV)
Regulatory compliance and ICH-GCP
Microsoft Office Suite
 
OTHER REQUIREMENTS:
Strong understanding of clinical trial regulations and Good Clinical Practice (GCP)
Ability to independently manage monitoring activities with minimal oversight
Excellent written communication skills for monitoring reports and site correspondence
Strong organizational and follow-up skills
Experience in neuroscience, neurology, and/or imaging research preferred
 
KEY RESPONSIBILITIES
Conduct independent onsite and remote monitoring activities for Phase I and Phase II clinical research studies.
Schedule and coordinate monitoring visits directly with study sites.
Perform source data verification and ensure protocol compliance.
Review informed consent forms, regulatory files, source documentation, and study records for accuracy and completeness.
Prepare monitoring visit reports, confirmation letters, and follow-up letters.
Follow up with study sites to ensure action items are completed and resolved.
Review and resolve Electronic Data Capture (EDC) queries.
Ensure compliance with study protocols, sponsor requirements, ICH-GCP guidelines, and applicable regulatory requirements.
Support ongoing quality assurance and monitoring activities throughout the study lifecycle.
Collaborate with investigators, study coordinators, sponsors, and research teams to support successful study execution.
Communicate study risks, protocol deviations, and monitoring findings to appropriate stakeholders while driving timely resolution.
 
 
 
Our client is the one of the largest Healthcare Staffing Provider in the United States, to be assigned at one of their affiliated hospitals/healthcare facilities.
 
 
This particular client is requiring that all new hires show proof of vaccination. However, accommodations may be made for those with disabilities or religious reasons who cannot obtain a vaccine.
 
Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide.
 
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
 
Don't miss out on this amazing opportunity! If you feel your experience is a match for this position please apply today and join our team. We look forward to working with you!