Senior CRA- Texas

Company: ICON Strategic Solutions
Location: Bismarck
Posted on: January 26, 2023

Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.What will you be doing?

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing
• Able to work within remote teams and
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Good interpersonal
• Strong planning & organizational skills, and the ability to work efficiently and effectively in a dynamic
• Respects confidentiality in terms of
• Proactive, conscientious and precise in delivery of quality work even when under pressure
• Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely
• Flexible with high learning and change agility
• Collaborative, building strong internal and external
• Knowledge of local regulations, IND/ICH GCP - guidelines,
• Available and willing to travel as job requires
• Strong computer skills with good eye for
• Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team
• Engage and maintain good written and verbal communication with external stakeholders in order to ensure effective study
• Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate:
• Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out
• Performs site evaluation visits:
• Determines the feasibility of the study protocol with reference to study complexity
• Confirms staff availability, suitable clinical facilities, potential for per protocol patient population,
• Confirms ability to comply with ICH GCP and requirements for clinical studies.
• Works with Study staff to carry out a local study / site level risk
• Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures so that they can effectively run the clinical
• Participate in global investigators and/or monitor meetings as appropriate. Facilitates investigators participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.
• Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are
• Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).
• Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.
• Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
• Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames.
• Completes monitoring visit reports within the agreed
• Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).
• Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.
• Ensure sponsor study records are inspection ready at all times and archives records as applicable.What do y ou need to have?Education required:
  • Undergraduate degree or its international equivalent in clinical, science, or health-related fieldfrom an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience preferredSkills Required
    • Read, write and speak fluent English; fluent in host country language required.
    • 2-4 years of clinical monitoring experience required
    • Knowledge of ICH and local regulatory authority regulations regarding drug
    • Clinical research experience
    • Knowledge of ICH and local regulatory authority regulations regarding drug
    • Experience in monitoring all trial components (PSSV to COV)
    • Experience in coaching/mentoring other CRABenefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Keywords: ICON Strategic Solutions, Bismarck , Senior CRA- Texas, Other , Bismarck, North Dakota