Sr. Clinical Trial Associate

4 weeks ago

Menlo Park, United States Summit Therapeutics Sub, Inc. Full time
Job DescriptionJob Description

Overview of Role:

The CTA/Sr. CTA is responsible for supporting the daily workflow of clinical operations activities. The CTA/Sr. CTA provides administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the eTMF and vendors.

Role and Responsibilities:

  • Provides administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes.
  • Executes tasks as assigned by the Clinical Operations Manager, including study budget forecasting and tracking.
  • Ensures accurate and timely documentation, including eTMF management, study contracts and financial records in compliance with ICH-GCP, company policies and regulatory requirements.
  • Coordinates clinical operations activities across cross-functional teams, including contract management, vendor oversight, site start-up and activation, protocol deviation.
  • Creates and maintains study-related materials, such as country and site binders and tracks trial milestones.
  • Ensure the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMF.
  • Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC.
  • Attend and contribute to team meetings, taking detailed meeting minutes.
  • Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors.
  • Actively participates in process improvement initiatives to enhance clinical operations efficiency.

Experience, Education and Specialized Knowledge and Skills:

  • 3+ Years of experience in clinical study environment within CRO or Pharmaceutical company.
  • Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out.
  • Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines
  • Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks.
  • Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment.
  • Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form.
  • Attention to detail, accuracy and confidentiality.
  • Critical thinking, problem solving, ability to work independently.
  • Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods.
  • Work in a fast-paced, demanding and collaborative environment.
  • Demonstrate high ethical standards for honesty, truthfulness and integrity.
  • This position is hybrid, in the Menlo Park, CA office 3 days a week.

The pay range for this role is $108,336 to $120,242 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.

  • Senior Clinical Trial Coordinator

    2 weeks ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Position OverviewRole Summary:The Senior Clinical Trial Associate (Sr. CTA) plays a pivotal role in facilitating the daily operations of clinical research activities. This position entails providing comprehensive administrative assistance to study teams throughout the clinical trial lifecycle. Key responsibilities encompass managing meeting logistics,...

  • Clinical Trial Manager

    1 week ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to...

  • Senior Manager of Clinical Trials

    2 weeks ago

    Menlo Park, California, United States Summittherapeutics Full time

    Position Overview:An accomplished and self-sufficient clinical operations expert tasked with overseeing all facets of Clinical Trial Management for international studies. This role encompasses the initiation, execution, and closure of studies. You will coordinate and lead cross-functional teams, contract research organizations (CROs), and vendors to ensure...

  • Senior Clinical Trial Coordinator

    2 weeks ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job OverviewPosition Summary:The Senior Clinical Trial Associate plays a crucial role in facilitating the daily operations of clinical studies. This position involves providing essential administrative support to study teams throughout the clinical trial process. Key responsibilities include managing meeting logistics, organizing agendas, documenting meeting...

  • Senior Clinical Trial Manager

    1 week ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to...

  • Senior Clinical Trial Coordinator

    3 days ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummarySummit Therapeutics Sub, Inc. is seeking a highly skilled Clinical Operations Specialist to support the daily workflow of clinical operations activities. The ideal candidate will provide administrative support to study teams, manage meeting logistics, and ensure accurate and timely documentation.Key ResponsibilitiesAdministrative Support: Provide...

  • Clinical Operations Associate

    16 hours ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummarySummit Therapeutics Sub, Inc. is seeking a highly skilled Clinical Operations Associate to support the daily workflow of clinical operations activities. The ideal candidate will provide administrative support to study teams, manage meeting logistics, create agendas, and draft meeting minutes.Key ResponsibilitiesAdministrative Support: Provide...

  • Clinical Trial Assistant

    3 weeks ago

    Overland Park, Kansas, United States IQVIA Full time

    Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

  • Associate Director Clinical Operations

    3 weeks ago

    Menlo Park, United States The Steely Group Full time

    M-F standard hours with OT - this is a true startupOnsite in Menlo Park, CAAssociate Director/Director, Clinical OperationsJob OverviewWe are looking for a talented and highly motivated Clinical Operations professional to join our client's fast-paced biotech startup. Under the direction of the Executive Director, Clinical Operations, this role will support...

  • Senior Manager, Clinical Data Management

    2 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Summit is seeking an experienced, detail-oriented Sr. Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology...

  • Senior Manager, Clinical Data Management

    6 days ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:Summit is seeking an experienced, detail-oriented Sr. Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology...

  • Sr. Manager, Statistical Programming

    3 weeks ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:The Senior Manager, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of...

  • Clinical Quality Assurance Manager

    2 weeks ago

    Menlo Park, California, United States Corcept Therapeutics Full time

    The Clinical Quality Assurance Manager plays a vital role within the Clinical Quality Assurance (CQA) division, overseeing daily quality operations and compliance measures to ensure the success of clinical trials managed or supported by Corcept Therapeutics.Key Responsibilities:Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical...

  • Director, Clinical Operations

    4 days ago

    Menlo Park, United States Summit Therapeutics Sub, Inc. Full time

    Job DescriptionJob DescriptionOverview of Role:The Director will serve as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit Therapeutics. This role should demonstrate strong matrix management skills, confidence in working...

  • Clinical Quality Assurance Manager

    2 weeks ago

    Menlo Park, California, United States Corcept Therapeutics Full time

    The Manager of Clinical Quality Assurance (CQA) plays a vital role within the CQA team, overseeing daily clinical quality operations and compliance tasks essential for the successful execution of clinical trials supported by Corcept Therapeutics.Key Responsibilities:Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical...

  • Clinical Study Manager

    3 days ago

    Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

    Job SummarySummit Therapeutics Sub, Inc. is seeking a highly skilled Clinical Operations Specialist to support the daily workflow of clinical operations activities. The ideal candidate will provide administrative support to study teams, manage meeting logistics, and ensure accurate and timely documentation.Key ResponsibilitiesAdministrative Support: Provide...

  • Associate Manager, Pharmacovigilance

    1 month ago

    Florham Park, United States Clinical Resource Network (CRN) Full time

    Our client is looking for a Associate Manager, Pharmacovigilance for a Hybrid position in the Livingston, NJ area.Responsibilities:Responsible for full oversight of individual case safety reports (ICSRs) and aggregate safety reports for company product portfolio.Manage review of individual case safety reports to ensure timely processing of adverse event...

  • Clinical Quality Assurance Manager

    2 weeks ago

    Menlo Park, California, United States Corcept Therapeutics Full time

    The Clinical Quality Assurance Manager plays a vital role within the Clinical Quality Assurance (CQA) team, overseeing daily quality operations and compliance measures to ensure the effective execution of clinical trials supported by Corcept Therapeutics.Key Responsibilities:Oversee and conduct Good Clinical Practice (GCP) audits, which encompass clinical...

  • Sr. Attorney

    1 week ago

    Monterey Park, United States YangLawOffices.com Full time

    Job Details Sr. Attorney Company name: Yang Law Offices Experience: 5 yrs required Location: Monterey Park, CA, United States Employment Type: Full-Time Industry: Legal Posted on: Jul 10, 2023 Profile Yang Law Offices is a boutique law firm headquartered in the City of Monterey Park, with a team of 12 attorneys, specializing in family law, estate planning,...

  • Manager, Clinical Site Operations RWE Clinical Trials- Overland Park

    3 weeks ago

    Overland Park, United States Walgreens Full time

    Job Description Job Summary The Manager, Clinical Site Operations reports to the Director, Clinical Site Operations, and functions as the direct manager for patient-facing site staff supporting assigned studies. This role supervises clinical trial activities, the implementation of and adherence to study protocols, and oversees the schedules of...