Contract Clinical Research Associate
2 semanas atrás
Contract CRA Project - 40 hours per week 1 year contract. Seizure or Epilepsy - CNSJob Summary: We are seeking a detail-oriented and experiencedClinical Research Associate (CRA)to monitor and managePhase 2 Seizure studyclinical 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 inLife Sciences ,Nursing , or a related field. At least2-4 yearsof experience as a Clinical Research Associate in oncology trials, with preference forPhase 2experience. Strong knowledge ofGood Clinical Practice (GCP) ,FDAregulations, andICHguidelines. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Excellent organizational, problem-solving, and communication skills.Preferred Qualifications: Previous experience inearly-phase oncology trials(e.g., dose escalation studies, first-in-human trials). Strong understanding of pharmacokinetics (PK) and pharmacodynamics (PD) assessments. Certification as aClinical Research Professional (CCRA)is a plus.
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Niterói, Brasil Insidehighered Tempo inteiroThe Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University.Hiring staff "for fit" makes significant contributions to Howard University's overall mission.At Howard University, we prioritize well-being and professional growth.Here is what we offer:Health &...
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Niterói, Brasil Insidehighered Tempo inteiroThe Talent Acquisition department hires qualified candidates to fill positions which contribute to the overall strategic success of Howard University.Hiring staff "for fit" makes significant contributions to Howard University's overall mission.At Howard University, we prioritize well-being and professional growth.Here is what we offer:Health &...
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Niterói, Brasil Go! Running Tours Tempo inteiroGrowth Marketer – Global Running Company (Part-Time) Hi… My name is Lena, and I am the founder of Go! Running Tours. This is not your usual job post. Instead of writing a fast‑paced, bullet‑pointed post with the words driven, team player, high performer, etc., I thought I would give it a go at simply writing the good, the bad, and the ugly about...
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