Posted:
7/8/2024, 3:47:08 AM
Location(s):
Florida, United States
Experience Level(s):
Junior ⋅ Mid Level
Field(s):
Legal & Compliance
At Memorial, we are dedicated to improving the health, well-being and, most of all, quality of life for the people entrusted to our care. An unwavering commitment to our service vision is what makes the difference. It is the foundation of The Memorial Experience.
Summary:
Essential: * BachelorsResponsibilities:
Participate in and assist with the preparation and training of investigators, residents, fellows, new research staff and pharmacist educational programs.
Review Eligibility criteria for the Medical Research team when manager is not available, and/or for registry studies.
Performs source data verification of all clinical trial related documentation (e.g. investigator qualifications, staff training, Electronic Medical Record and research source documentation, etc.), issuing queries as needed, to ensure proper adherence to SOPs and applicable regulatory requirements.
Review 100% of all newly completed ICFs for completeness and accuracy.
Completes monitoring reports and communicates monitoring results to OHR department leadership and research team, including Principal Investigators Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions; escalates unacceptable findings to OHR leadership, as appropriate.
Independently schedule, coordinate and conduct protocol/project specific for cause audits related to allegations of research non-compliance, high risk, high enrollment or randomly selected investigator protocols, including providing monitoring for investigator initiated trials and preparation for external audits.
Assist Research Specialists with the filing of Protocol Deviations and Serious Adverse Event reporting.
Competencies:
ACCOUNTABILITY, ACCURACY, CUSTOMER SERVICE, DEVELOPS RELATIONSHIPS, EFFECTIVE COMMUNICATION, RESEARCH - PROJECT MANAGEMENT, RESEARCH - REPORTING, RESPONDING TO CHANGE, STANDARDS OF BEHAVIOREducation and Certification Requirements:
Bachelors (Required)Driver's License Num (DRIVER LIC) - Department of Motor VehiclesAdditional Job Information:
Complexity of Work: Ability to problem solve and multi-task, excellent computer skills and proficiency of the English language. Requires critical thinking skills, effective communication skills, decisive judgment and the ability to work with minimal supervision. Demonstrated ability to work effectively as a team member. Proficient in Windows, MS Word, Excel. Driving to our different hospitals to conduct on site audits/monitoring. Required Work Experience: Three (3) years of experience as a monitor, research specialist/study coordinator, or a regulatory coordinator. Prior Oncology and/or hematology experience preferred, including experience in research auditing, monitoring or quality assurance/quality control. Other Information: Certified as CHRC, ACRP or SOCRA certification preferred.Additional Education Info: in science, healthcare or RN degree or background as a medical professional.Working Conditions and Physical Requirements:
Shift:
Primarily for office workers - not eligible for shift differentialDisclaimer: This job description is not intended, nor should it be construed to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with the job. It is intended to indicate the general nature and level of work performed by employees within this classification.
Wages shown on independent job boards reflect market averages, not specific to any employer. We encourage candidates to talk to their Memorial Healthcare System recruiter to discuss actual pay rates, during the hiring process.
Memorial Healthcare System is proud to be an equal opportunity employer committed to workplace diversity.
Memorial Healthcare System recruits, hires and promotes qualified candidates for employment opportunities without regard to race, color, age, religion, gender, gender identity or expression, sexual orientation, national origin, veteran status, disability, genetic information, or any factor prohibited by law.
We are proud to offer Veteran’s Preference to former military, reservists and military spouses (including widows and widowers). You must indicate your status on your application to take advantage of this program.
Employment is subject to post offer, pre-placement assessment, including drug testing.
If you need reasonable accommodation during the application process, please call 954-276-8340 (M-F, 8am-5pm) or email [email protected]
Website: https://mhs.net/
Headquarter Location: Hollywood, Florida, United States
Employee Count: 10001+
Year Founded: 1953
Industries: Health Care ⋅ Hospital