Contract Clinical Research Associate

Há 6 dias

Recife, Brasil Barrington James Tempo inteiro

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.

  • Senior Clinical Research Associate

    Há 2 dias

    Recife, Brasil Bebeeclinical Tempo inteiro

    Job Opportunity:This role offers the chance to work as a Senior Clinical Research Associate on a Phase II/III Epilepsy Study.The study spans 6-8 sites across the Central and Eastern U.S., with a contract duration of 12 months.Responsibilities:Independent monitoring of clinical trials

  • Freelance Clinical Research Associate

    2 semanas atrás

    Recife, Brasil beBeeClinical Tempo inteiro

    **Job Title:** Freelance Clinical Research Associate Role Overview: In this role, you will lead site visits and ensure high-quality data as a seasoned clinical research professional. Conduct thorough site evaluations and initiations to assess compliance and efficiency Verify GCP compliance and integrity by monitoring data collection processes Collaborate...

  • Freelance Clinical Research Associate

    2 semanas atrás

    Recife, Brasil Bebeeclinical Tempo inteiro

    **Job Title:** Freelance Clinical Research AssociateRole Overview:In this role, you will lead site visits and ensure high-quality data as a seasoned clinical research professional.Conduct thorough site evaluations and initiations to assess compliance and efficiencyVerify GCP compliance and integrity by monitoring data collection processesCollaborate with...

  • Senior Clinical Trials Coordinator

    2 semanas atrás

    Recife, Brasil beBeeClinicalResearchAssociate Tempo inteiro

    Clinical Research Associate Role Our company has numerous opportunities for dedicated professionals to join our team of Clinical Research Associates. As a member of this team, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies....

  • Senior Clinical Trials Coordinator

    2 semanas atrás

    Recife, Brasil Bebeeclinicalresearchassociate Tempo inteiro

    Clinical Research Associate RoleOur company has numerous opportunities for dedicated professionals to join our team of Clinical Research Associates.As a member of this team, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.Key...

  • Logistics Manager

    Há 5 dias

    Recife, Brasil Bebeesupply Tempo inteiro

    Key roles and responsibilities of a Supply Chain Analyst include determining product demand, sourcing suppliers, negotiating contracts, and selecting reliable vendors.The ideal candidate should have:Key QualificationsDemonstrated experience in supply chain management or related fields.Proficiency in SAP or SAP B1 software.A degree in supply chain management,...

  • Logistics Manager

    Há 5 dias

    Recife, Brasil beBeeSupply Tempo inteiro

    Key roles and responsibilities of a Supply Chain Analyst include determining product demand, sourcing suppliers, negotiating contracts, and selecting reliable vendors. The ideal candidate should have: Key Qualifications Demonstrated experience in supply chain management or related fields. Proficiency in SAP or SAP B1 software. A degree in supply chain...

  • Elevate Academic Excellence

    Há 5 dias

    Recife, Brasil Bebeeeditor Tempo inteiro

    Senior Editor OpportunitiesWe are seeking experienced professionals to elevate the quality and impact of academic papers.Our ideal candidate will have a strong research background, a respected reputation in their field, and one of the following senior-level experiences:Currently organizing and guest-editing a Special Issue for an EI Compendex-indexed...

  • Business Development Professional

    Há 20 horas

    Recife, PE, Brasil beBeeAdministrative Tempo inteiro

    Account Manager Job Title: Account Manager We are seeking a highly skilled and organized Account Manager to join our team. The ideal candidate will be responsible for maintaining CRM hygiene, creating follow-ups, preparing reports, and supporting contract preparation. Maintain CRM hygiene across all deals and pipelines in HubSpot Create follow-ups and tasks...

  • Client Services, Interpretation

    2 semanas atrás

    Recife, Brasil Cadence Tempo inteiro

    About UsCadence () is a language services firm servicing the due diligence industry.We started in Beijing in **** and the types of clients we serve are expert networks, investment firms, consulting firms and market research firms.We are a remote-first company whose staff is located across multiple countries.Each individual is functionally aligned to one of...