Site Qualification Specialist (Remote)
- Job Title
- Site Qualification Specialist (Remote)
- Job ID
- 27559240
- Work From Home
- Yes
- Location
- Austin, TX 78738
- Other Location
- Description
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JOB SUMMARY
The Site Qualification Specialist (SQS) will be responsible for qualifying new practices as research ready by performing a site assessment, creating a site profile, collecting essential documents and assessing credentials. The SQS will work in collaboration with the Healthcare Partners, Practice Success, Training and Regulatory leaders to ensure that new practices and Investigators are qualified, trained, equipped and capable in all other aspects of research readiness for various therapeutic areas and all Elligo models. The SQS may have one or more direct reports.
RESPONSIBILITIES
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Collecting all documents needed to create a site profile for a new healthcare practice location. This may include the Site Assessment Form, CVs and licenses of key staff, site contact list, etc.
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Works with practice representatives to ensure all capabilities are obtained and then submitted to Salesforce
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Ensure practice assessment relevant to the practice is completed
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Regularly maintain practice assessment templates per therapeutic area
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Provides site set up expertise to ensure new practices are in a position to qualify for and conduct clinical trials as quickly as possible
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Evaluates site equipment needs and works with others at Elligo to ensure the appropriate research infrastructure is in place
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Works with Training Coordinator to ensure all verification of credentials, debarment checks, FDA 483 checks have been performed and are clear
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Collects and sends all GCP, HSP training, Insurance (if applicable) to Training Coordinator to file for relevant staff
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Ensure all GCP, HSP and Elligo (corporate) SOP training is completed
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Participates in Handoff meetings
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Send newly onboarded practices Elligo certificates, pins and other trinkets as tokens of appreciation
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Maintains confidentiality, prioritizes and manages work effectively and provides exceptional customer service internally and externally
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Demonstrates knowledge of the Company’s clinical research studies
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Works cross functionally with other departments/groups
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Performs other duties and responsibilities as required
QUALIFICATION AND EDUCATION REQUIREMENTS
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BS/BA in Life Science or related discipline. CCRC/CCRP certification preferred.
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Requires a minimum 3 yrs clinical research experience (including Industry-sponsored research studies)
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Demonstrated ability in positive relationship building, with strong verbal and written skills required
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Previous supervisory experience desired
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Strong interpersonal skills with attention to detail a must
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Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint)
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Strong organization/prioritization skills for the management of multiple concurrent projects
WORKING CONDITIONS
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.
Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.
Regular travel (25-50%) travel is required for this position.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc.
Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.
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