Clinical Research Coordinator
3 weeks ago
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:
Location: Coventry, UK
Ensures the safety of our volunteers. Promotes the mission of PMG to function as an Integrated Site Network. Consistently strives to meet and exceed priorities as discussed with direct supervisor. Actively recruiting and promoting our service to suitable participants and sponsor representatives. Performing tasks required to coordinate and complete a study according to the protocol and maintaining communication with the Manager of Clinical Operations regarding training, orientation, or other concerns regarding the coordination of clinical trials.
Responsibilities:
• Develop and maintains proper skills to comply with the protocol, federal regulatory requirements, internal SOP’s, and COG’s
• Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
• 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.
• Communicates with the Manager of Clinical Operations regarding training/orientation, recruitment efforts, the overall status of a trial(s), and other concerns.
• Attends investigator meetings.
• Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines.
• Accurately collects study data via source documents/progress notes as required by the protocol.
• Performs technical requirements of the study 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, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.
• Performs continuous reviews of the inclusion and exclusion criteria for each participant during the screening period.
• Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.
• Builds strong relationships with Investigators and provides ongoing communication about trial status and participants.
• Dispenses study medication at the discretion of the Investigator.
• Maintains communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits.
• Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor.
• Addresses all queries or data clarifications within 48 hours of receipt.
• Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in timely manner during these visits.
• Reports protocol violations and significant deviations to the Manager of Clinical Operations.
• Establishes relationships with volunteers, and participates in patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process.
• Assists other staff members as determined by the needs and priorities of the research organization and as time and abilities permit.
• Anticipates possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement.
• Prepares study documentation in the event of a PMG, sponsor, or FDA audit and assists the auditor for the duration of the audit including correcting discrepancies in a timely manner. • Completes and tracks referrals for patients where required as per protocol.
• Requesting and following up on patient records form primary physician where required.
• Travel: Travel to other sites within the network may be required to support increases in workload and, or studies/projects as needed.
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.
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