Talent.com
No longer accepting applications
Clinical Research Associate II / CRA I - Sponsor Dedicated - ONC + Gen Med (Home-based in Western US)

Clinical Research Associate II / CRA I - Sponsor Dedicated - ONC + Gen Med (Home-based in Western US)

Syneos Health / inVentiv Health Commercial LLCDenver, CO, United States
3 days ago
Job type
  • Temporary
Job description

Clinical Research Associate II / CRA I - Sponsor Dedicated - ONC + Gen Med (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 activities 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. 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.
  • For assigned activities, understands project scope, budgets, and timelines; 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 study 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 in 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.
  • Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. 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
  • Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior 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.

    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
  • Ability to manage required travel of up to 75% on a regular basis
  • US ONLY : As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk.
  • 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 • Denver, CO, United States

    Related jobs
    • Promoted
    Travel Cath Lab Tech - $2,494 to $2,733 per week in Brighton, CO

    Travel Cath Lab Tech - $2,494 to $2,733 per week in Brighton, CO

    AlliedTravelCareersBRIGHTON, CO, US
    Full-time
    AlliedTravelCareers is working with AMN Healthcare Allied to find a qualified Cath Lab Tech in BRIGHTON, Colorado, 80601!. Job Description & Requirements.Cath Lab Technologist - (Cath Lab Tech) ...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Research Associate II - Sponsor Dedicated - ONC + Gen Med (Home-Based in Western US)

    Clinical Research Associate II - Sponsor Dedicated - ONC + Gen Med (Home-Based in Western US)

    Syneos Health / inVentiv Health Commercial LLCDenver, CO, United States
    Remote
    Full-time
    Clinical Research Associate II - Sponsor Dedicated - ONC + Gen Med (Home-Based in Western US).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerat...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Cath Lab Tech - $3,003 per week in Brighton, CO

    Travel Cath Lab Tech - $3,003 per week in Brighton, CO

    AlliedTravelCareersBrighton, CO, US
    Full-time
    AlliedTravelCareers is working with Medical Solutions to find a qualified Cath Lab Tech in Brighton, Colorado, 80601!.A facility in Brighton, CO is seeking its next amazing Cath Lab Technologist.Re...Show moreLast updated: 27 days ago
    • Promoted
    Travel Cath Lab Tech - $3,214 per week in Brighton, CO

    Travel Cath Lab Tech - $3,214 per week in Brighton, CO

    AlliedTravelCareersBrighton, CO, US
    Full-time
    AlliedTravelCareers is working with Coast Medical Service to find a qualified Cath Lab Tech in Brighton, Colorado, 80601!. Coast Medical Service is a nationwide travel nursing & allied healthcar...Show moreLast updated: 9 days ago
    • Promoted
    CDL-A Truck Drivers - Home Daily Options - Earn $75,400 - $82,212 / Yr

    CDL-A Truck Drivers - Home Daily Options - Earn $75,400 - $82,212 / Yr

    C.R. EnglandBuffalo Creek, CO, US
    Full-time
    England is now hiring Local CDL-A Drivers in Denver, CO!.Local CDL-A Driver Opportunity - Daily Home Time!.Average $75,400 Annually - Top 10% Earn $82,212 per Year •. Are you an experienced CDL-A dri...Show moreLast updated: 1 day ago
    • Promoted
    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,642 to $1,810 per week in Golden, CO

    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,642 to $1,810 per week in Golden, CO

    TravelNurseSourceGOLDEN, CO, US
    Full-time
    TravelNurseSource is working with AMN Healthcare to find a qualified ICU / Critical Care RN in GOLDEN, Colorado, 80033!.Job Description & Requirements. Registered Nurse – Intensive Care - ICU - T...Show moreLast updated: 9 days ago
    • Promoted
    Travel Cath Lab Tech - $2,556 to $2,938 per week in Brighton, CO

    Travel Cath Lab Tech - $2,556 to $2,938 per week in Brighton, CO

    AlliedTravelCareersBrighton, CO, US
    Full-time
    AlliedTravelCareers is working with Fusion Medical Staffing to find a qualified Cath Lab Tech in Brighton, Colorado, 80601!. Facility in Brighton, Colorado.Fusion Medical Staffing is seeking a skill...Show moreLast updated: 3 days ago
    • Promoted
    Clinical Research Associate II / Sr CRA - Full Service - ONC + Gen Med (Home-Based in Western US)

    Clinical Research Associate II / Sr CRA - Full Service - ONC + Gen Med (Home-Based in Western US)

    Syneos Health / inVentiv Health Commercial LLCDenver, CO, United States
    Remote
    Temporary
    Clinical Research Associate II / Sr CRA - Full Service - ONC + Gen Med (Home-Based in Western US).Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accel...Show moreLast updated: 30+ days ago
    Senior Associate Scientist (I / II), In Vivo Antibody Discovery

    Senior Associate Scientist (I / II), In Vivo Antibody Discovery

    Mosaic BiosciencesBoulder, CO, US
    Full-time
    Quick Apply
    Mosaic Biosciences is a biotherapeutics drug discovery company that partners with biopharmaceutical companies to discover novel protein and antibody therapeutics. Our experienced and dedicated resea...Show moreLast updated: 30+ days ago
    • Promoted
    Travel Vascular Tech - $2,494 to $2,733 per week in Brighton, CO

    Travel Vascular Tech - $2,494 to $2,733 per week in Brighton, CO

    AlliedTravelCareersBRIGHTON, CO, US
    Full-time
    AlliedTravelCareers is working with AMN Healthcare Allied to find a qualified Vascular Tech in BRIGHTON, Colorado, 80601!. Job Description & Requirements.Cardiovascular Interventional Technologi...Show moreLast updated: 22 days ago
    • Promoted
    Travel Cath Lab Tech - $3,025 per week in Brighton, CO

    Travel Cath Lab Tech - $3,025 per week in Brighton, CO

    AlliedTravelCareersBrighton, CO, US
    Full-time
    AlliedTravelCareers is working with Triage Staffing LLC to find a qualified Cath Lab Tech in Brighton, Colorado, 80601!.Travel Radiology : Cath Lab Tech Brighton. Shift Details : 8H Days (12 : 00 AM-1...Show moreLast updated: 30+ days ago
    • Promoted
    CRA 2, Oncology, IQVIA Biotech

    CRA 2, Oncology, IQVIA Biotech

    IQVIADenver, CO, 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: 3 days ago
    • Promoted
    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,941 per week in Golden, CO

    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,941 per week in Golden, CO

    TravelNurseSourceGolden, CO, US
    Full-time
    TravelNurseSource is working with Triage Staffing to find a qualified ICU / Critical Care RN in Golden, Colorado, 80439!. Travel Nursing : Intensive Care Unit Golden.Shift Details : 12H Nights (12 : 00 ...Show moreLast updated: 9 days ago
    • Promoted
    CRA 2, Oncology, Full Service, IQVIA

    CRA 2, Oncology, Full Service, IQVIA

    IQVIADenver, CO, 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: 3 days ago
    Regional Clinical Research Manager

    Regional Clinical Research Manager

    Urology America, MSODenver, CO, US
    Full-time
    Quick Apply
    The Regional Clinical Research Manager is responsible for the coordination and administration of clinical trials at 3-4 clinical research site locations within a designated region under the directi...Show moreLast updated: 30+ days ago
    • Promoted
    AIISR Research Professional

    AIISR Research Professional

    University of Colorado Anschutz Medical CampusAurora, CO, United States
    Full-time
    University of Colorado Anschutz Medical Campus.Working Title : AIISR Research Professional.Intermediate Laboratory Science Professionals perform duties in an experimental lab, or wet lab, and handle...Show moreLast updated: 5 days ago
    • Promoted
    RN Clinical Coordinator OR

    RN Clinical Coordinator OR

    AH Rocky MountainCastle Rock, CO, US
    Full-time
    All the benefits and perks you need for you and your family : .Student Loan Repayment Program.Whole Person Wellbeing Resources. Joining AdventHealth is about being part of something bigger.Its about b...Show moreLast updated: 29 days ago
    • Promoted
    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,719 to $1,829 per week in Golden, CO

    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,719 to $1,829 per week in Golden, CO

    TravelNurseSourceGolden, CO, US
    Full-time
    TravelNurseSource is working with Fusion Medical Staffing to find a qualified ICU / Critical Care RN in Golden, Colorado, 80401!. Fusion Medical Staffing is seeking a ICU RN for a 13-week travel assig...Show moreLast updated: 9 days ago