- 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 any clinical trial, and assisting CRC Level I and Level II with the planning and conduct of trials
- Anticipating the specific recruitment needs and constantly evaluating the recruitment needs for any clinical trial and communicating recruitment efforts to the Manager of Clinical Operations
- Developing and executing recruitment plans that generate randomized patients and 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 and assisting the auditor for the duration of the audit including correcting discrepancies 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.
- Bachelors' Degree or Equivalent experience required
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Senior Clinical Research Coordinator - Winston Salem, United States - ICON Clinical Research
Description
At ICON, it's our people that set us apart.Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity.
We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.
In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us.
You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
The Role
Title :
_Senior Clinical Research Coordinator_
_Location_ _:
Winston-Salem, NC_
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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 through the form below.
