Clinical Study Associate

2 days ago


Warren, United States Tech Observer Full time

Duties:

Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Clinical Study Oversight Plan (CSOP).

Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.


Skills:

A Bachelor’s degree (preferred in Life Sciences) with relevant clinical development experience is acceptable.

Experience considered relevant includes 3 years of clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred.

Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.



  • Warren, United States Tech Observer Full time

    Duties: Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International...


  • warren, United States Tech Observer Full time

    Duties:Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International...


  • warren, United States Tech Observer Full time

    Duties:Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International...


  • Warren, United States Omni Inclusive Full time

    Detailed Position Responsibilities • Production of blood component lots through cell culture, harvest, and cryopreservation. • Aseptic technique • Become fully trained and qualified in all aspects of assigned processes • Develop a high level of technical knowledge of project(s) • Weigh and measure in-process materials to ensure proper quantities...


  • Warren, United States PTC Therapeutics Full time

    Job Description Summary: The Senior Manager, Statistical Programming performs the programming activities for clinical development programs and associated clinical studies either directly or through Contract Research Organization (CRO) oversight. Participates in the development of new and review of existing statistical programming standard operating...


  • Warren, United States PTC Therapeutics Full time

    Job Description Summary: The Senior Manager, Statistical Programming performs the programming activities for clinical development programs and associated clinical studies either directly or through Contract Research Organization (CRO) oversight. Participates in the development of new and review of existing statistical programming standard operating...


  • Warren, Pennsylvania, United States Health Advocates Network, Inc. Full time

    Job Summary: Health Advocates Network, Inc. is seeking a highly skilled Speech Language and Hearing Specialist to provide advanced clinical services to individuals with auditory, speech, language, and related disabilities. The ideal candidate will possess a Master's degree in Communicology or a related field and be certified by the American Speech-Language...


  • Warren, United States Baumer Medical Inc. Full time

    We are an established medical practice serving Cincinnati, Indianapolis , and the surrounding area performing evaluations on patients with swallowing disorders. Presently we are in need of additional physicians to join our group. Both full-time and part time and positions are available. All doctors with various experiences are encouraged to apply. During...

  • New CNAs

    5 months ago


    Warren, United States Ascension Full time

    Ascension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At Ascension Medical Group - Cardiovascular Associates Macomb, caregivers can find both a jumpstart to their careers and clinical education opportunities....


  • Warren, United States Foxconn-PCE Technology Full time

    Job DescriptionJob DescriptionFSLA Status: Non-ExemptLocation: Lordstown, OHShift: First ShiftReports To: Tool and Die SupervisorPrimary Function: As a Tool and Die Associate you will be responsible for supporting the Stamping department by repairing and maintaining automotive stamping dies. Perform complex die repairs and modifications (weld, die spot,...


  • Warren, United States Howland Community Animal Hospital Full time

    OverviewHowland Community Animal Hospital is Hiring!We are looking for a Full-Time Associate Veterinarian to join our fun-loving hospital!!At Howland Community Animal Hospital, nothing takes higher priority than the health of our patients. Our greatest mission is to continuously provide the highest quality veterinary care and services to pets and their...


  • Warren, United States Bon Secours Mercy Health Full time

    At Bon Secours Mercy Health, we are dedicated to continually improving health care quality, safety and cost effectiveness. Our hospitals, care sites and clinicians are recognized for clinical and operational excellence. Job Description **This position is represented by a collective bargaining agreement.** **Summary of Primary Function** The Unit Hospitality...

  • Nursing Assistant

    4 weeks ago


    Warren, Michigan, United States PACE Southeast Michigan Full time

    Job Summary: We are seeking a skilled Nursing Assistant - Community Living Associate (CLA) to join our team at PACE Southeast Michigan. As a CLA, you will play a vital role in providing supportive services to our participants, ensuring their physical and emotional comfort in their community living setting.**Responsibilities:**Develop and implement...


  • Warren, United States Barbaricum Full time

    Barbaricum is a rapidly growing government contractor providing leading-edge support to federal customers, with a particular focus on Defense and National Security mission sets. We leverage more than 15 years of support to stakeholders across the federal government, with established and growing capabilities across Intelligence, Analytics, Engineering,...

  • Respiratory Therapist

    4 weeks ago


    Warren, United States Mercy Health Full time

    Everyone who works with Mercy Health is united under one purpose: to help our patients be well in mind, body and spirit. This drive, along with our history of faith, is a powerful combination. It gives us a shared calling to work toward every day. Join our exceptional team and help us continue to provide the highest quality of health care possible to our...


  • Warren, United States Katalyst Healthcares & Life Sciences Full time

    Responsibilities: Working under the direction of the Team Lead / Project Manager, the senior statistical programmer conducts programming activities for a trial, early phase project, indication, or publication activities. Lead at least one study team in terms of providing technical and domain-related guidance. May required to lead and manage a team of 2-4...


  • Warren, United States Katalyst Healthcares & Life Sciences Full time

    Responsibilities: Working under the direction of the Team Lead / Project Manager, the senior statistical programmer conducts programming activities for a trial, early phase project, indication, or publication activities. Lead at least one study team in terms of providing technical and domain-related guidance. May required to lead and manage a team of...

  • General Dentist

    3 weeks ago


    Warren, United States Dental365 Full time

    Job DescriptionJob DescriptionJoin the future of dentistry, led by dentistsAt Dental365, we're reshaping the way patients experience dental care. By placing patients and providers at the core of our approach, we're breaking new ground in the world of dentistry. Since our inception in 2014, we've touched the lives of hundreds of thousands of...

  • General Dentist

    4 days ago


    Warren, United States Dental365 Full time

    Join the future of dentistry, led by dentists At Dental365, we're reshaping the way patients experience dental care. By placing patients and providers at the core of our approach, we're breaking new ground in the world of dentistry. Since our inception in 2014, we've touched the lives of hundreds of thousands of patients and have emerged as a leading and...

  • RBT (Sign-on Bonus)

    7 hours ago


    Warren, United States Comprehensive Behavior Supports Full time

    RBT (Sign-on Bonus) Department:Behavior Technician Location:Warren, NJ Are you a psychology student looking to gain hands-on experience in a growing field? Our entry-level position as a Registered Behavior Technician (RBT) / ABA Therapist offers a perfect way to get your foot in the door of behavioral health while making a positive impact on the lives of...