Talent.com
Senior Clinical Research Associate / CRA II - Sponsor Dedicated - Oncology (Home-Based in Western US)
Senior Clinical Research Associate / CRA II - Sponsor Dedicated - Oncology (Home-Based in Western US)Syneos Health/ inVentiv Health Commercial LLC • Seattle, WA, United States
Senior Clinical Research Associate / CRA II - Sponsor Dedicated - Oncology (Home-Based in Western US)

Senior Clinical Research Associate / CRA II - Sponsor Dedicated - Oncology (Home-Based in Western US)

Syneos Health / inVentiv Health Commercial LLC • Seattle, WA, United States
30+ days ago
Job type
  • Temporary
  • Remote
Job description

Senior Clinical Research Associate / CRA II - Sponsor Dedicated - Oncology (Home-Based in Western US)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and / or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates / escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject / patient as required / appropriate. Demonstrates diligence in protecting the confidentiality of each subject / patient. Assesses factors that might affect subject / patient's safety and clinical data integrity at an investigator / physician site such as protocol deviation / violations and pharmacovigilance issues.
  • Per the Clinical Monitoring / Site Management Plan (CMP / SMP) : Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements
  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects / patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released / returned.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan / Site Management Plan. Supports subject / patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • Understands project scope, budgets, and timelines for own and others' activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
  • May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • Prepares for and attends Investigator Meetings and / or sponsor face to face meetings. Participates, and may, with supervision, lead, global clinical monitoring / project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • May provide training or mentorship to more junior level CRAs. May perform training and sign off visits for junior CRA staff, as assigned.
  • May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager. For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include : Site support throughout the study lifecycle from site identification through close out
  • Knowledge of local requirements for real world late phase study designs

    Chart abstraction activities and data collection

    As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff

    Identify and communicate out of scope activities to Lead CRA / Project Manager

    Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

    Identify operational efficiencies and process improvements

    Develop country level informed consent forms

    Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared

    Participate in bid defense meetings

    Qualifications :

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice / ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills. Basic level of critical thinking skills expected.
  • Ability to manage required travel of up to 75% on a regular basis
  • At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions / bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

    Salary Range :

    The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

    Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

    No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    http : / / www.syneoshealth.com

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

    Create a job alert for this search

    Research Associate Ii • Seattle, WA, United States

    Related jobs
    Clinical Research Associate II

    Clinical Research Associate II

    Allen Spolden • Seattle, WA, 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 more
    Last updated: 30+ days ago • Promoted
    Radiology / Imaging - CT Tech

    Radiology / Imaging - CT Tech

    Swedish Medical Center Mill Creek Campus - Providence • Everett, WA, United States
    Full-time
    Swedish Medical Center Mill Creek Campus - Providence.Show more
    Last updated: 12 days ago • Promoted
    Radiology / Imaging - CT Tech

    Radiology / Imaging - CT Tech

    Providence Swedish Medical Center Mill Creek Campus • Everett, WA, United States
    Full-time
    Providence Swedish Medical Center Mill Creek Campus.Days - Please verify shift details with recruiter.Genie Healthcare is looking for a Radiology / Imaging to work in CT Tech for a 13 weeks travel as...Show more
    Last updated: 13 days ago • Promoted
    Scientific - Associate Research Scientist

    Scientific - Associate Research Scientist

    Bristol Myers Squibb • Seattle, WA, United States
    Full-time
    Job Title : Scientific - Associate Research Scientist.Work Schedule- Standard Shift Hours; M-F.The Sequencing and Automation team, part of the Molecular Innovation and Discovery group within Cell Th...Show more
    Last updated: 9 days ago • Promoted
    Clinical Research Coordinator - Tumor Institute

    Clinical Research Coordinator - Tumor Institute

    Providence • Seattle, WA, United States
    Full-time
    Independently coordinates research and administrative tasks in support of one or more research studies.Works with study investigators and supervisor to address study-related issues.Backs up other c...Show more
    Last updated: 30+ days ago • Promoted
    Associate Veterinarian

    Associate Veterinarian

    Northwest Animal Care • Everett, WA, US
    Full-time
    Northwest Animal Care Hospital .You give so much of yourself to your work.Here at Northwest Animal Care Hospital, a Thrive Pet Healthcare partner, we recognize what you and your team face each da...Show more
    Last updated: 30+ days ago
    Regional Sales Associate

    Regional Sales Associate

    RepRally • North Lakewood, WA, United States
    Full-time
    We are seeking a motivated and customer-focused Field Sales Representative to join our dynamic team as we change the distribution industry. We're creating a unified platform that connects brands, sa...Show more
    Last updated: 30+ days ago • Promoted
    Scientific - Associate Research Scientist (Seattle)

    Scientific - Associate Research Scientist (Seattle)

    Bristol Myers Squibb • Seattle, WA, US
    Part-time
    Job Title : Scientific - Associate Research Scientist.Work Schedule- Standard Shift Hours; M-F.The Sequencing and Automation team, part of the Molecular Innovation and Discovery group within Cell Th...Show more
    Last updated: 9 days ago • Promoted
    RN - Radiation Oncology

    RN - Radiation Oncology

    Providence • Everett, WA, United States
    Full-time
    Providence nurses are not simply valued - they're invaluable.You will thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect.Your voice m...Show more
    Last updated: 30+ days ago • Promoted
    RN - Neurology

    RN - Neurology

    MultiCare Health System • Tacoma, WA, United States
    Full-time
    At MultiCare, we strive to offer a true sense of belonging for all our employees.Across our health care network, you will find a dynamic range of meaningful careers, opportunities for growth, safe ...Show more
    Last updated: 30+ days ago • Promoted
    Senior Associate Scientist

    Senior Associate Scientist

    Sunrise Systems • Seattle, Washington, United States
    Temporary
    Quick Apply
    Job Title : Senior Associate Scientist.Contract (Possible extension based on work performance).We are seeking an Analytical Method Automation Sr. Associate Scientist to contribute to the development ...Show more
    Last updated: 30+ days ago
    Neuro-Oncology Clinician-Researcher (Academic)

    Neuro-Oncology Clinician-Researcher (Academic)

    UW Medicine • Seattle, WA, United States
    Full-time
    An exciting opportunity awaits at a prestigious institution dedicated to advancing cancer research and treatment.Join a collaborative team of experts in neuro-oncology, where you will engage in gro...Show more
    Last updated: 3 days ago • Promoted
    Clinical Research Associate 1

    Clinical Research Associate 1

    Allen Spolden • Seattle, WA, 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 more
    Last updated: 30+ days ago • Promoted
    Remote Market Research Associate (Hiring Immediately)

    Remote Market Research Associate (Hiring Immediately)

    Earn Haus • Picnic Point, Washington, US
    Remote
    Full-time +1
    We are urgently looking for people interested in taking online surveys for Fortune 500 brands.If you are a self-starter, looking for flexible hours throughout the week, this may be for you! Earn up...Show more
    Last updated: 30+ days ago • Promoted
    RN - Radiation Oncology

    RN - Radiation Oncology

    Providence Health and Services • Everett, WA, United States
    Full-time
    RN - Radiation Oncology at Providence Health and Services summary : .The RN - Radiation Oncology position at Providence Regional Medical Center Everett involves providing specialized nursing care to ...Show more
    Last updated: 3 hours ago • Promoted • New!
    Hiring : Research Associate-Scientific || Seattle WA

    Hiring : Research Associate-Scientific || Seattle WA

    Sunrise Systems • Seattle, Washington, United States
    Temporary
    Quick Apply
    Job Title : Research Associate-Scientific.Duration : 12 Month Contract (Possible extension based on work performance).ELISA, qPCR, and mammalian tissue culture. Perform routine analytical testing, pro...Show more
    Last updated: 30+ days ago