Clinical Research Associate

3 weeks ago

Ridgefield, United States McInnis, Inc. Full time
The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with overall study execution. The CRA may also assist with data management, vendor management and site monitoring as needed.

Duties and Responsibilities
  • Act as the primary point of contact with assigned clinical study sites during start-up activities;
  • Working with finance and legal experts, drive contract and budget negotiations (or amendments) with assigned sites;
  • Review site-level documents needed for IRB/EC/REC approval;
  • Support study initiation, monitoring, audit and close-out phases of assigned clinical trials as prescribed in the sponsor SOPs and study monitoring plan;
  • Ensure clinical study site documentation compliance according to GCPs, ICH and FDA regulations;
  • Provide relevant, timely study subject updates to the Clinical Study Manager(s) (e.g., upcoming treatment dates, subject withdrawals, etc.);
  • Facilitate timely and accurate communication flow between the clinical study sites, sponsor and applicable vendors;
  • Collaborate with clinical study site and sponsor to troubleshoot and provide appropriate solutions to study-related issues, as appropriate;
  • Assist in patient recruitment activities;
  • Assist with the development of study-related documents as requested;
  • Prepare accurate and timely study reports as requested;
  • Work independently and under general supervision.

Education
  • Bachelor's degree (or higher) in nursing, health sciences or related field;

Qualifications
  • Experience with clinical trial contract and budget negotiations
  • Finance experience preferred
  • Minimum of two years of CRA experience, with clinical site monitoring experience preferred;
  • Strong oral and written communication skills;
  • Good understanding of FDA regulations related to clinical trials; GCPs and ICH Guidance;
  • Proven organizational skills and the ability to manage multiple priorities;
  • Strong computer skills;
  • Ability to travel with adequate prior notification

  • Clinical Research Associate

    1 week ago

    Ridgefield, United States McInnis Inc. Full time

    The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...

  • Clinical Research Associate

    5 days ago

    Ridgefield, United States McInnis Inc. Full time

    The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...

  • Clinical Research Associate

    4 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...

  • Clinical Research Associate

    1 month ago

    Ridgefield, United States McInnis Inc. Full time

    The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...

  • Clinical Research Associate

    4 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    Job DescriptionJob DescriptionThe Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned...

  • Clinical Research Associate

    7 days ago

    Ridgefield, United States McInnis Inc. Full time

    The Clinical Research Associate will support clinical research activities within research sites that are actively participating in clinical trials. Under the direction of the Clinical Study Manager(s), the Clinical Research Associate (CRA) will assist with study and site start-up activities by working directly with assigned clinical sites and assist with...

  • Clinical Monitoring Associate

    1 month ago

    Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full time

    Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. - Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs...

  • Clinical Monitoring Associate

    4 weeks ago

    Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full time

    Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. - Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs...

  • Clinical Monitoring Associate/clinical Trail

    1 month ago

    Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full time

    Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study. - Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs...

  • Clinical Monitoring Associate/clinical Trail

    1 month ago

    Ridgefield, United States ADIENT INDIA PRIVATE LIMITED Full time

    Department: CD O Site Monitoring - USBB20 Job Category: Clinical and Scientific Job Title: Site Monitoring Lead Duties: Trial Preparation: - Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of...

  • Clinical Administrative Associate

    3 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    *This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...

  • Clinical Administrative Associate

    4 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    Job DescriptionJob Description*This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational...

  • Clinical Administrative Associate

    1 month ago

    Ridgefield, United States McInnis Inc. Full time

    *This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...

  • Clinical Administrative Associate

    3 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    *This Position is onsite in Ridgefield, CT* Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...

  • Clinical Administrative Associate

    3 weeks ago

    Ridgefield, United States McInnis Inc. Full time

    *This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...

  • Medical Technical Writer, Fully Home Based

    4 weeks ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionOutside EST ZONE candidate requested not to apply.Duties:Manages and writes/edits relevant sections of global clinical documents, required for advancing clinical development programs in global, cross-functional study and project teams. Manages all technical aspects of GMW document development as well as publishing and archiving...

  • Sourcing Manager/Contract management, supplier relationship

    3 weeks ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionSourcing ManagerDuties:- Local Implementation to Category Strategy following TOM (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.Identify, evaluate and classify sourcing risks and Manage risk exposure with mitigation measures.- Identify and evaluate existing and potential local...

  • Bioinformatics / Computational Scientist III (Remote/Onsite)

    2 weeks ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionNeed someone ideally who knows details of pros and cons for a wide range of bioinformatics tools and database so the candidate can come up with solution and summarize well about the findings in data analysis and knows how to use advanced data science such as graph will be a plus. We are not looking for someone to build...

  • Sourcing Manager/Contract management/RFP process

    3 weeks ago

    Ridgefield, United States Maxis Clinical Sciences Full time

    Job DescriptionJob DescriptionJob Title: Sourcing ManagerDuties: - Implement complex Category Strategy following TOM and develop it for corporate center led model (incl. Complex and/or high spend negotiation) and inform accordingly local Business Partners BPs.- Bring potential innovation to Client and local market intelligence.- Identify, evaluate and...

  • Clinical Trial Monitor III

    3 weeks ago

    Ridgefield, United States JobRialto Full time

    DescriptionAccountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study.Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight...