Senior CRC- Accellacare- Long Beach CAICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Title: Senior CRCLocation: Long Beach, CADuties: Adhering to the study protocol. Maintaining proper documentation according to the protocol, regulatory requirements, and internal SOPs. Complying with all federal and local regulatory requirements, sponsor and protocol requirements and company procedures. Performing study start-up duties including the production of a recruitment plan, recruitment tool and progress notes, as well as phone screening patients. Anticipating and planning for the logistical needs and requirements for anyclinical trial, and assisting CRC Level I and Level II with the planning andconduct of trials. Anticipating the specific recruitment needs and constantly evaluating therecruitment needs for any clinical trial and communicating recruitment efforts tothe Manager of Clinical Operations. Developing and executing recruitment plans that generate randomized patientsand maximizing patient retention rates Attending investigator meetings. Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment. Performing technical requirements of the study protocol and training others in regards to technical requirements of a protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, maintaining hep-locks or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol. Performing continuous reviews of the inclusion and exclusion criteria for each patient during the screening period. Documenting laboratory data and adverse reactions, presenting this information to an investigator in a timely manner, and immediately notifying investigators, the Institutional Review Board and sponsor of any serious adverse events. Dispensing study medication at the direction of the Investigator. Establishing relationships with patient volunteers, and participating in patient education regarding the clinical trial process and providing specific trial information to the participant as well as conducting the informed consent process. Able to utilize web based applications such as Microsoft Office or other web based systems or a willingness to learn the applications. Working with investigators by communicating the status of patients referred, overall recruitment status, and clinical needs of the study. Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. Anticipating possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement and communicating to the Manager of Clinical Operations. Maintaining communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits. Establishing strong relationships with monitors and sponsors. Proactively promoting the site with monitors and in-house contacts for future trials. Engaging in prospecting for new potential business with our current customers and new customers. Developing new physician relationships, and enhancing or leveraging the involvement of our current physician investigators. Participating in PMG leadership meetings as a representative of the site. Responsible for the promotion of PMG company strategies with the site staff. Preparing study documentation in the event of a PMG, sponsor, or FDA audit andassisting the auditor for the duration of the audit including correctingdiscrepancies in a timely manner. Internal monitoring and review of other coordinators and support staff. Attending site evaluation visits as a senior staff representative. Assisting in the training and development of support and other site personnel. Travel: Travel to other sites within the network may be required to support increases in workload and, or studies/projects as needed.Duties: Adhering to the study protocol. Maintaining proper documentation according to the protocol, regulatory requirements, and internal SOPs. Complying with all federal and local regulatory requirements, sponsor and protocol requirements and company procedures. Performing study start-up duties including the production of a recruitment plan, recruitment tool and progress notes, as well as phone screening patients. Anticipating and planning for the logistical needs and requirements for anyclinical trial, and assisting CRC Level I and Level II with the planning andconduct of trials. Anticipating the specific recruitment needs and constantly evaluating therecruitment needs for any clinical trial and communicating recruitment efforts tothe Manager of Clinical Operations. Developing and executing recruitment plans that generate randomized patientsand maximizing patient retention rates Attending investigator meetings. Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment. Performing technical requirements of the study protocol and training others in regards to technical requirements of a protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, maintaining hep-locks or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol. Performing continuous reviews of the inclusion and exclusion criteria for each patient during the screening period. Documenting laboratory data and adverse reactions, presenting this information to an investigator in a timely manner, and immediately notifying investigators, the Institutional Review Board and sponsor of any serious adverse events. Dispensing study medication at the direction of the Investigator. Establishing relationships with patient volunteers, and participating in patient education regarding the clinical trial process and providing specific trial information to the participant as well as conducting the informed consent process. Able to utilize web based applications such as Microsoft Office or other web based systems or a willingness to learn the applications. Working with investigators by communicating the status of patients referred, overall recruitment status, and clinical needs of the study. Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. Anticipating possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement and communicating to the Manager of Clinical Operations. Maintaining communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits. Establishing strong relationships with monitors and sponsors. Proactively promoting the site with monitors and in-house contacts for future trials. Engaging in prospecting for new potential business with our current customers and new customers. Developing new physician relationships, and enhancing or leveraging the involvement of our current physician investigators. Participating in PMG leadership meetings as a representative of the site. Responsible for the promotion of PMG company strategies with the site staff. Preparing study documentation in the event of a PMG, sponsor, or FDA audit andassisting the auditor for the duration of the audit including correctingdiscrepancies in a timely manner. Internal monitoring and review of other coordinators and support staff. Attending site evaluation visits as a senior staff representative. Assisting in the training and development of support and other site personnel. Travel: Travel to other sites within the network may be required to support increases in workload and, or studies/projects as needed.What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.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, colour, 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 or submit a request here (https://careers.iconplc.com/reasonable-accommodations)Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.Salary range: -Bonus, Com, Stock, Benefits & Disclaimer verbiage:Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply
