Talent.com
Sr Clinical Research Associate - In house CRA

Sr Clinical Research Associate - In house CRA

Planet PharmaSouth San Francisco, CA, United States
19 hours ago
Job type
  • Full-time
Job description

Job Description

Position Summary

The Sr. Clinical Research Associate (CRA) will manage clinical aspects of a small to medium-sized clinical study or, with supervision, assume some management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols.

  • Local candidates, who can work in the SSF HQ office 2-3 days per week

Essential Duties And Responsibilities

  • Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH / GCP, and corporate and departmental program goals.
  • Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.
  • Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed.
  • Helps to oversee aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision.
  • Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
  • Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes.
  • Participates in the review / implementation of study design from an operations perspective and implements tactics at a site level.
  • May support Study Lead in the review of CRO / Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection.
  • Supports Study Lead in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables.
  • Participates in the development of critical study documents such as informed consent form templates, site management monitoring tools, FAQs, processes, and workflows.
  • Participates in the development, distribution, review, and tracking of essential trial documents.
  • Strives to ensure timelines and deliverables are met within budget.
  • Participates in the development of and ensures compliance with the clinical monitoring plan; monitors as needed for training and quality assurance (QA) purposes.
  • Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution.
  • Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review.
  • Liaises internally to forecast and monitor overall drug supply throughout the trial.
  • Supports other study-wide activities as assigned - such as external vendors, sample handling, investigator payments, overall data quality, and overall central records quality.
  • Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions.
  • Contributes to the SOP review process and / or other Clinical Operations Initiatives
  • Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC / audits.
  • Practices professionalism and integrity in all actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done.
  • TRAVEL

    Up to 30%

    Requirements

    Education

  • Bachelor's degree in a relevant scientific discipline
  • Minimum 3-4 years of clinical trial management experience working for a Sponsor company, CRA / field monitor, or CRO setting.
  • Experience

  • Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA / field monitor, or CRO setting. Global experience a plus.
  • A good understanding of the drug development process, ICH guidelines / GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.
  • Self-motivated and able to motivate others.
  • Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
  • Strong attention to detail and ability to prioritize tasks to meet critical deadlines.
  • Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools.
  • Proficiency in Microsoft suite or products such as Word, Excel etc.
  • Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

    Fraud Alert : Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

    Create a job alert for this search

    Clinical Research Associate • South San Francisco, CA, United States

    Related jobs
    • Promoted
    Clinical Research Associate II - Temporary

    Clinical Research Associate II - Temporary

    Bio-Rad LaboratoriesHercules, CA, United States
    Full-time
    As a CRA at Bio-Rad, you will play a vital role in ensuring the successful conduct of clinical trials from initiation to closeout. You will collaborate with numerous investigators, study coordinator...Show moreLast updated: 11 days ago
    • Promoted
    Clinical Research Associate

    Clinical Research Associate

    LanceSoftSan Francisco, CA, United States
    Full-time
    Responsible for overall clinical study management, including planning, communication, coordination and practical tasks for the studies. Coordinates Ethical Committee and Institutional Review Board n...Show moreLast updated: 1 day ago
    • Promoted
    Clinical Research Associate 1

    Clinical Research Associate 1

    Allen SpoldenSan Francisco, CA, United States
    Full-time
    Responsible for providing Clinical Research support for all clinical trials.Under the direction of supervisor or designee, this position will serve as support for the clinical study team.Essential ...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Research Associate (CRA)

    Clinical Research Associate (CRA)

    Caribou BiosciencesBerkeley, CA, United States
    Temporary
    Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases.Our next-gene...Show moreLast updated: 1 day ago
    • Promoted
    CRA 2, Oncology, IQVIA Biotech

    CRA 2, Oncology, IQVIA Biotech

    IQVIASan Francisco, CA, United States
    Part-time
    IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring as well as experience monitoring in oncology. IQVIA Biotech is a full-service CRO purpose-built to serve biotech ...Show moreLast updated: 1 day ago
    • Promoted
    Clinical Research Associate II (Contractor)

    Clinical Research Associate II (Contractor)

    Dynavax TechnologiesEmeryville, CA, United States
    Temporary
    This position can be 100% remote, but must be located in the United States.Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines to help protect the ...Show moreLast updated: 1 day ago
    • Promoted
    Clinical Research Associate

    Clinical Research Associate

    AmpcusSan Francisco, CA, United States
    Full-time
    Technology and Business consulting services.We are in search of a highly motivated candidate to join our talented Team.Shift : Day 5x8-Hour (08 : 00 - 17 : 00). The CRA will be responsible for ensuring p...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Clinical Research Associate

    Senior Clinical Research Associate

    Precision Point StaffingSan Jose, CA, United States
    Full-time
    Senior Research Associate – Oncology.San Francisco, CA (On-site 3 days / week).Our client, an innovative biotechnology company focused on advancing oncology therapeutics, is seeking a.This individual...Show moreLast updated: 8 days ago
    • Promoted
    Staff Research Associate IV, Supervisor

    Staff Research Associate IV, Supervisor

    Northern California Institute for Research and EducationSan Francisco, CA, United States
    Full-time
    This position will serve as a program manager and senior clinical research coordinator for a large research program who is capable of making difficult decisions independently.As a program manager, ...Show moreLast updated: 1 day ago
    • Promoted
    Clinical Research Associate (CRA) - A

    Clinical Research Associate (CRA) - A

    Manpower Group Inc.Sunnyvale, CA, United States
    Full-time
    Clinical Research Associate (CRA).Internal Clinical Research Associate (CRA).The Internal CRA will assist in managing clinical research sites throughout the entire trial lifecycle-from start-up to ...Show moreLast updated: 1 day ago
    • Promoted
    • New!
    CRA 2, Early Clinical Development, IQVIA Biotech

    CRA 2, Early Clinical Development, IQVIA Biotech

    IQVIASan Francisco, CA, United States
    Part-time
    IQVIA Early Clinical Development is hiring for CRA 2.Ideal candidates will have Phase 1 and / or Phase 2 experience across a variety of therapeutics. Seeking candidates located East, Central or West C...Show moreLast updated: 19 hours ago
    • Promoted
    CRA 2, Oncology, Full Service, IQVIA

    CRA 2, Oncology, Full Service, IQVIA

    IQVIASan Francisco, CA, United States
    Part-time
    IQVIA is seeking a CRA 2 with a minimum of 1.Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requi...Show moreLast updated: 1 day ago
    • Promoted
    • New!
    Clinical Research Associate (CRA) - A

    Clinical Research Associate (CRA) - A

    ExperisSunnyvale, CA, United States
    Full-time
    Clinical Research Associate (CRA).Internal Clinical Research Associate (CRA).The Internal CRA will assist in managing clinical research sites throughout the entire trial lifecycle-from start-up to ...Show moreLast updated: 19 hours ago
    • Promoted
    Clinical Research Associate

    Clinical Research Associate

    Calyxo, Inc.Pleasanton, CA, United States
    Full-time
    The company was founded in 2016 to address the profound need for improved kidney stone treatment.Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resourc...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Research Associate II

    Clinical Research Associate II

    Summit TherapeuticsMenlo Park, CA, United States
    Full-time
    On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami, FL office.Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational. PD-1 with the anti-angiogenesis e...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Clinical Research Associate

    Senior Clinical Research Associate

    Precision Point StaffingSanta Clara, CA, US
    Full-time
    Senior Research Associate – Oncology.San Francisco, CA (On-site 3 days / week).Our client, an innovative biotechnology company focused on advancing oncology therapeutics, is seeking a.This individual...Show moreLast updated: 7 days ago
    • Promoted
    Sr. Manager, Research

    Sr. Manager, Research

    Pendulum TherapeuticsSan Francisco, CA, United States
    Full-time
    Pendulum Therapeutics is leading a revolution that is occurring around the world to improve physical and mental health by first understanding, then restoring and enhancing the human microbiome.Pend...Show moreLast updated: 30+ days ago
    • Promoted
    Sr CTM

    Sr CTM

    Planet PharmaSouth San Francisco, CA, United States
    Full-time
    Seeking a highly motivated Senior Clinical Trial Manager (Sr.CTM) to be a part of our Clinical Operations team.This is a unique opportunity to join a growing company committed to converting biologi...Show moreLast updated: 8 days ago