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Job Summary
SummaryWorks independently under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. Will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting.
Does this position require Patient Care? No
Essential Functions
-Coordinate patient appointments with physicians, nurses, and all test areas.
-Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition.
-Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all criteria.
-Enroll patients as required by the study sponsor and internal enrollment monitor team.
-Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance.
-Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
-Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations.
-Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study.
-Collect, complete, and submit essential regulatory documents to various regulatory entities.
Qualifications
Education
Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree?
No
Licenses and Credentials
Experience
Clinical Research or compliance experience 1-2 years preferred
Knowledge, Skills and Abilities
- Ability to work independently and as a team member.
- Analytical skills and ability to resolve problems.
- Ability to interpret acceptability of data results.
- Careful attention to detail.
- Good organizational and communication skills.
- Working knowledge of clinical research protocols.
Additional Job Details (if applicable)
Remote Type
Hybrid
Work Location
300 First Avenue
Scheduled Weekly Hours
0
Employee Type
Per Diem
Work Shift
Day (United States of America)
Pay Range
$19.76 - $28.44/Hourly
Grade
5
EEO Statement:
The Spaulding Rehabilitation Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.
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