Talent.com
CRA I - Sponsor Dedicated - 1 years of monitoring experience (Home-based, Midwest of US)
CRA I - Sponsor Dedicated - 1 years of monitoring experience (Home-based, Midwest of US)Syneos Health/ inVentiv Health Commercial LLC • Louisville, KY, United States
CRA I - Sponsor Dedicated - 1 years of monitoring experience (Home-based, Midwest of US)

CRA I - Sponsor Dedicated - 1 years of monitoring experience (Home-based, Midwest of US)

Syneos Health / inVentiv Health Commercial LLC • Louisville, KY, United States
1 day ago
Job type
  • Temporary
  • Remote
Job description

CRA I - Sponsor Dedicated - 1 years of monitoring experience (Home-based, Midwest of 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 Pharmacoepidemiological Practices (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 with guidance 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.
  • For 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 project 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, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
  • May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). 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.
  • For Real World Late Phase, the CRA I will use the business card title of 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

    Collaboration with Sponsor affiliates, medical science liaisons and local country staff

    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

    Monitoring • Louisville, KY, United States

    Related jobs
    Senior Data Science Programmer

    Senior Data Science Programmer

    VirtualVocations • Louisville, Kentucky, United States
    Full-time
    A company is looking for a Senior Analytical Data Science Programmer Consultant (Remote).Key Responsibilities Develop, validate, and maintain datasets and statistical outputs for clinical trials,...Show more
    Last updated: 14 hours ago • Promoted • New!
    CRNA / Anesthesiology / Kentucky / Permanent / Southeast CRNA -$350k+Total Income Job

    CRNA / Anesthesiology / Kentucky / Permanent / Southeast CRNA -$350k+Total Income Job

    The Medicus Firm • Louisville, KY, US
    Permanent
    Elevate Your Career : CRNA Opportunity in the Southeast! $350K Total Income-Year 1 Are you seeking a fulfilling CRNA position that balances competitive compensation with an exceptional quality of li...Show more
    Last updated: 30+ days ago • Promoted
    Senior Project Manager, Life Sciences

    Senior Project Manager, Life Sciences

    JLL • Louisville, Kentucky, United States
    Full-time
    This job is with JLL, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.JLL empowers you to ...Show more
    Last updated: 1 day ago • Promoted
    Premium Auditor

    Premium Auditor

    Davies Risk Services • Crestwood, KY, US
    Full-time
    Quick Apply
    Join Davies Risk Services as a Premium Auditor — No Experience Required!.Are you a self-starter who thrives on independence, loves working with numbers, and enjoys meeting new people?.Do you ...Show more
    Last updated: 30+ days ago
    Senior Statistical Programmer

    Senior Statistical Programmer

    VirtualVocations • Louisville, Kentucky, United States
    Full-time
    A company is looking for a Senior Statistical Programmer to provide SAS programming expertise for clinical data analysis. Key Responsibilities Lead statistical programming for assigned projects an...Show more
    Last updated: 30+ days ago • Promoted
    Scientific Programmer

    Scientific Programmer

    VirtualVocations • Louisville, Kentucky, United States
    Full-time
    A company is looking for a Scientific Programmer.Key Responsibilities Conduct data analysis and GIS Develop software using Python, manage databases, and implement version control practices Work...Show more
    Last updated: 2 days ago • Promoted
    Sr Technical Project Manager

    Sr Technical Project Manager

    Syneos Health / inVentiv Health Commercial LLC • Salem, IN, United States
    Full-time
    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 ...Show more
    Last updated: 30+ days ago • Promoted
    Travel Electrophysiology Lab RN - $2,666 per week

    Travel Electrophysiology Lab RN - $2,666 per week

    Planet Healthcare • Louisville, KY, United States
    Full-time
    Planet Healthcare is seeking a travel Electrophysiology Technician for a travel job in Louisville, Kentucky.Job Description & Requirements. Planet Healthcare Job ID #72392609.Pay package is based on...Show more
    Last updated: 27 days ago • Promoted
    Travel Cath Lab Technologist - $2,826 per week

    Travel Cath Lab Technologist - $2,826 per week

    Springboard Healthcare • St Marys, IN, US
    Full-time
    Springboard Healthcare is seeking a travel Cath Lab Technologist for a travel job in South Bend, Indiana.Job Description & Requirements Specialty : Cath Lab Technologist Discipline : Allied Health Pr...Show more
    Last updated: 21 days ago • Promoted
    Remote Market Research Participant (Hiring Immediately)

    Remote Market Research Participant (Hiring Immediately)

    Earn Haus • Madison, IN, United States
    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
    Travel Cath Lab Technologist - $2,666 per week

    Travel Cath Lab Technologist - $2,666 per week

    Planet Healthcare • St Marys, IN, US
    Full-time
    Planet Healthcare is seeking a travel Cath Lab Technologist for a travel job in South Bend, Indiana.Job Description & Requirements Specialty : Cath Lab Technologist Discipline : Allied Health Profess...Show more
    Last updated: 30+ days ago • Promoted
    Research Assistant

    Research Assistant

    TradeJobsWorkForce • 47102 Austin, IN, US
    Full-time
    Research Assistant Job Duties : Generates hypotheses and designs and performs experiments to test ...Show more
    Last updated: 30+ days ago • Promoted
    Travel Electrophysiology Lab RN - $2,550 per week

    Travel Electrophysiology Lab RN - $2,550 per week

    Skyline Med Staff Allied • Louisville, KY, United States
    Full-time
    Skyline Med Staff Allied is seeking a travel Electrophysiology Technician for a travel job in Louisville, Kentucky.Job Description & Requirements. Join the Top- Rated Travel Healthcare Team!.Skyline...Show more
    Last updated: 30+ days ago • Promoted
    Travel Electrophysiology Lab RN - $2,631 per week

    Travel Electrophysiology Lab RN - $2,631 per week

    Anders Group • Louisville, KY, United States
    Full-time
    Anders Group is seeking a travel Electrophysiology Technician for a travel job in Louisville, Kentucky.Job Description & Requirements. Pay package is based on 8 hour shifts and 40 hours per week (su...Show more
    Last updated: 30+ days ago • Promoted
    Travel Cath Lab Technologist - $2,686 per week

    Travel Cath Lab Technologist - $2,686 per week

    Arrow Healthcare Staffing • St Marys, IN, US
    Full-time
    Arrow Healthcare Staffing is seeking a travel Cath Lab Technologist for a travel job in South Bend, Indiana.Job Description & Requirements Specialty : Cath Lab Technologist Discipline : Allied Health...Show more
    Last updated: 30+ days ago • Promoted
    Travel Cath Lab Technologist - $2,966 per week

    Travel Cath Lab Technologist - $2,966 per week

    Coast Medical Service • St Marys, IN, US
    Full-time
    Coast Medical Service is seeking a travel Cath Lab Technologist for a travel job in South Bend, Indiana.Job Description & Requirements Specialty : Cath Lab Technologist Discipline : Allied Health Pro...Show more
    Last updated: 30+ days ago • Promoted
    Subrogation Research and Creation Specialist

    Subrogation Research and Creation Specialist

    The Rawlings Group • La Grange, KY, US
    Full-time
    Research And Creation Team Specialist.Machinify is a leading healthcare intelligence company with expertise across the payment continuum, delivering unmatched value, transparency, and efficiency to...Show more
    Last updated: 8 days ago • Promoted
    X-Ray Technologist - Sign-On Bonus

    X-Ray Technologist - Sign-On Bonus

    Fast Pace Health • Salem, IN, United States
    Full-time
    Posting Title : X-Ray Technologist Overview : .Fast Pace Health strives to provide a best in class patient experience in every interaction. We are seeking a highly-skilled, experienced X-Ray Technologi...Show more
    Last updated: 30+ days ago • Promoted
    X-Ray Technologist

    X-Ray Technologist

    Fast Pace Health • Hanover, IN, United States
    Full-time
    Posting Title : X-Ray Technologist Overview : .Fast Pace Health strives to provide a best in class patient experience in every interaction. We are seeking a highly-skilled, experienced X-Ray Technologi...Show more
    Last updated: 30+ days ago • Promoted
    Veterinary Medical Director

    Veterinary Medical Director

    Crestwood Animal Hospital • Crestwood, KY, US
    Full-time
    Crestwood Animal Hospital – Crestwood, KY.Are you ready to lead a dynamic team while shaping the future of veterinary care? Join. Medical Director and make a lasting impact on both our team and comm...Show more
    Last updated: 30+ days ago