job specification

Contract CRA Project - 40 hours per week 1 year contract.
Seizure or Epilepsy - CNS
Job Summary:
We are seeking a detail-oriented and experienced
Clinical Research Associate (CRA)
to monitor and manage
Phase 2 Seizure study
clinical trials. The CRA will ensure the trial is conducted in compliance with regulatory standards, Good Clinical Practice (GCP), and the study protocol. This position involves collaborating with investigators, site personnel, and cross-functional teams to ensure the safety and well-being of participants in early-phase clinical trials.
Key Responsibilities:
Site Management and Monitoring:
Conduct site qualification, initiation, interim monitoring, and close-out visits.
Ensure proper site adherence to protocols, GCP, and regulatory requirements.
Verify and ensure accurate data collection and reporting.
Assess site performance and provide corrective actions if necessary.
Regulatory Compliance:
Ensure all clinical trial documentation is maintained according to regulatory guidelines.
Review informed consent documents and confirm proper consenting procedures.
Collaborate with regulatory teams to ensure timely submissions and approvals.
Safety and Data Management:
Monitor and report adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities.
Validate source data and resolve data discrepancies.
Ensure timely and accurate documentation of clinical trial data in electronic data capture (EDC) systems.
Collaboration and Communication:
Build and maintain relationships with study investigators and site staff.
Communicate study updates and findings to study sponsors and internal teams.
Provide training to site personnel on study protocols, procedures, and GCP compliance.
Qualifications:
Bachelor's degree in
Life Sciences ,
Nursing , or a related field.
At least
2-4 years
of experience as a Clinical Research Associate in oncology trials, with preference for
Phase 2
experience.
Strong knowledge of
Good Clinical Practice (GCP) ,
FDA
regulations, and
ICH
guidelines.
Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
Excellent organizational, problem-solving, and communication skills.
Preferred Qualifications:
Previous experience in
early-phase oncology trials
(e.g., dose escalation studies, first-in-human trials).
Strong understanding of pharmacokinetics (PK) and pharmacodynamics (PD) assessments.
Certification as a
Clinical Research Professional (CCRA)
is a plus.