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Clinical Research Regulatory Specialist I – II, Center for Clinical Research (Hybrid)
Position # : 2400071Q Position : Clinical Research Regulatory Specialist I – II, Center for Clinical Research (Hybrid) UH Facility : Cleveland Medical Center Shift : Days Status : Full-time Work Days of Week : M-F
City : Cleveland
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To Heal. To Teach. To Discover.
These words are more than just our mission, they embody the opportunities available to the world-class doctors, nurses, health care professionals and support staff who choose to join University Hospitals and Be the Difference.
From entry to executive level, every position and every professional at University Hospitals has a direct impact on our ability to offer excellent care to our patients, their families and our community.
Join Us and Be the difference in Advancing the Science of Health and the Art of Compassion.
Equal Opportunity Employer – minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.
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JOB DESCRIPTION & QUALIFICATIONS
Description
What You Will Do
- Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center. (20%)
- Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. (20%)
- Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials. (30%)
- Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations. (20%)
- Embraces the principles and practice of leadership and professionalism in clinical research.
- Provides mentorship and training on the clinical trial and regulatory process to staff members. (10%)
Additional Responsibilities
- Performs other duties as assigned.
- Complies with all policies and standards.
- For specific duties and responsibilities, refer to documentation provided by the department during orientation.
- Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
- Bachelor’s Degree and some related experience (Required) or
- Associate’s Degree with 4 years of clinical and/or research experience (Required)
Work Experience
- 2+ years of clinical research experience. (Required)
Knowledge, Skills, & Abilities
- Ability to prioritize the work of multiple projects. (Required proficiency)
- Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
- Ability to work consistently and effectively as part of a high performance work team. (Required proficiency)
- Ability to understand and communicate regulatory requirements to others. (Required proficiency)
- Demonstrate problem solving skills and effective negotiation skills. (Required proficiency)
- Medical terminology. (Required proficiency)
- Strong written communication skills to write and edit documents with the ability to take scientific documentation and present to the general population. (Required proficiency)
- Excellent interpersonal and verbal communication skills. (Required proficiency)
- Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications). (Required proficiency)
Licenses and Certifications
- Society of Clinical Research Associates (SoCRA) (Required) and
- ACRP Certified Professional (ACRP-CP) (Required)
- RAPS (Required)
Physical Demands
- Standing Occasionally
- Walking Occasionally
- Sitting Constantly
- Lifting Rarely 20 lbs
- Carrying Rarely 20 lbs
- Pushing Rarely 20 lbs
- Pulling Rarely 20 lbs
- Climbing Rarely 20 lbs
- Balancing Rarely
- Stooping Rarely
- Kneeling Rarely
- Crouching Rarely
- Crawling Rarely
- Reaching Rarely
- Handling Occasionally
- Grasping Occasionally
- Feeling Rarely
- Talking Constantly
- Hearing Constantly
- Repetitive Motions Frequently
- Eye/Hand/Foot Coordination Frequently
Travel Requirements
UH Cleveland Medical Center
UH Cleveland Medical Center is University Hospitals’ flagship academic medical center. With more than 1,000 registered beds, UH Cleveland Medical Center provides primary, specialty and subspecialty medical and surgical care in the heart of Cleveland’s University Circle.
Working at University Hospitals
Careers at University Hospitals offers opportunities to provide care locally in the Cleveland area with the power to impact healthcare nationwide. As a leader in our industry, our staff share a commitment to Be the Difference in the lives of our patients and our communities, from Northeast Ohio and beyond. Take a look at this video to discover how we’re building an organization for the future, today. Note: video content was obtained prior to the COVID-19 pandemic.
ANEESAH DAVIS: You have a choice to be here or not be here. The choice for me to just actually just stay here is just, I love it. I love it here to be honest and the opportunities that it allowed me to have and grow. That's basically why I choose to stay here. SONORA HOWSON: My favorite part is probably the people I work with. I mean I'm interested in the procedures and I feel like we do a lot of good. But like the thing that has me excited to come back every day is just that I work with such an incredible team. Really talented people and it feels like a family. I know that's like kind of trite to say but it does feel like that. ALVIN MANIGAULT: One of the things I was really impressed with my time being at UH, just from a managerial and leadership perspective, I think they do a phenomenal job. My leadership specifically in terms of just being involved and engaged and also listening as well to matters, issues or concerns and then working to establish some type of implementing change. I think subsequently for me as an employee, it really makes me feel as if I'm heard, my voice is heard and that also my perspective can have an impact on the overall overarching picture as well.
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It is the policy of University Hospitals to provide equal opportunity to all of our employees and applicants for employment. Decisions concerning employment, transfers and promotions or other conditions of employment are all made upon the basis of the best qualified candidate without regard to race, color, national origin, age, religion, veteran status, disability, gender, sexual orientation, gender identity, or marital status in accordance with Federal and Ohio law. A qualified individual with a disability will be considered for employment on the same basis as non- disabled applicants if he/she can perform the essential functions of the job sought, with or without a reasonable accommodation, and without imposing a direct threat to the health or safety of others or him/herself. EEO is the Law
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Research Associate - Remote - 131915
Job description, #131915 research associate - remote.
UCSD Layoff from Career Appointment : Apply by 09/05/2024 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants : Apply by 09/17/2024. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Candidates hired into this position may have the ability to work remotely.
DESCRIPTION
Under supervision, the Research Associate will play a critical role in the successful execution of two distinct research studies: one focused on Gulf War veterans to investigate Gulf War Illness and another focused on East Palestine, OH residents affected by the 2023 train derailment. This position involves developing and implementing effective recruitment strategies, engaging with the community, and coordinating research events to inform and enroll participants for both studies.
The coordinator will work closely with the research team to build and maintain relationships with community leaders, organizations, and potential participants. Additionally, the role includes organizing and managing research events in the East Palestine area, administering study visit via Zoom Pro and other tasks.
MINIMUM QUALIFICATIONS
Demonstrated communication skills. Ability to quickly comprehend written and oral instructions. Ability to write legibly to complete data collection forms. Ability to work effectively as a team member.
Knowledge and skill in using Microsoft and other software including Word, Excel, PowerPoint, and Outlook, as well as research databases, electronic case report forms, Canva, and other computer based programs. Ability to organize and concurrently manage information in several formats: paper, electronic, and oral.
Cultural competency in the veteran and East Palestine, Ohio population.
Knowledge in the processing and shipping of blood and urine laboratory specimens, both ambient and frozen. Familiarity with guidelines of biohazardous handling. Knowledge and strict utilization of universal precautions when handling laboratory specimens.
HIPAA Certification or willingness to be trained.
Certification in Blood Borne Pathogens or willingness to be trained.
Certification or willingness to be trained in hazardous shipping.
Demonstrated organizational skills. Experience planning, organizing, and managing the scheduling of study visits, sponsor visits or teleconferences, and meetings with key personnel, all in the midst of handling multiple priorities and deadlines.
Theoretical knowledge of a biological science such as Biology, Microbiology, Psychology, Cognitive Neuroscience or a related field.
PREFERRED QUALIFICATIONS
Experience coordinating clinical trials in a diseased population with multiple health problems. Ability to read scientific text for general understanding of basic concepts. Ability to summarize and convey technical and medical information to lay individuals at a level appropriate for their understanding.
Familiarity with regulatory documents needed for the conduct of clinical trials. Experience in submitting applications, consents and correspondence to the IRB and/or UCSD Human Research Protections Program for review and approval.
SPECIAL CONDITIONS
- Employment is subject to a criminal background check and pre-employment physical.
Pay Transparency Act
Annual Full Pay Range: $60,301 - $97,008 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $28.88 - $46.46
Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).
If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements. If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.
To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community .
UC San Diego is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.
For the University of California’s Affirmative Action Policy please visit: https://policy.ucop.edu/doc/4010393/PPSM-20 For the University of California’s Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination
UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.
UC San Diego Health maintains a marijuana and drug free environment. Employees may be subject to drug screening.
Application Instructions
Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!
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Posted : 9/3/2024
Job Reference # : 131915
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- Career Sites by Recruiting.com
Clinical Research Coordinator
- Madison, Wisconsin
- SCHOOL OF MEDICINE AND PUBLIC HEALTH/RADIOLOGY-GEN
- Partially Remote
- Staff-Full Time
- Staff-Part Time
- Opening at: May 31 2024 at 09:55 CDT
- Closing at: Sep 17 2024 at 23:55 CDT
Job Summary:
The Department of Radiology, University of Wisconsin - Madison, School of Medicine & Public Health is seeking a Clinical Research Coordinator (CRC) to help advance exciting medical imaging and disease-focused projects! The CRC works as part of a team, which includes physicians, PhD researchers, imaging staff, and other research support staff, to support and advance a portfolio of interesting research projects. Radiology projects focus on anything from the development of novel imaging techniques, to work towards understanding and curing disease. The role of a CRC is quite varied - an average day could include responsibilities ranging from recruiting and enrolling subjects into a study, to coordinating and conducting actual subject visits, to collaborations with the study team on a wide variety of topics.
Responsibilities:
Institutional statement on diversity:.
Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion
Preferred Bachelor's Degree
Qualifications:
Required - Research experience. Preferred - At least one year experience with clinical research studies. - Experience working within a higher education setting. - Prior experience working within a healthcare setting. The ideal candidate will have strong attention to detail and ability to think critically and/or strategically to solve problems.
Full or Part Time: 80% - 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. The incumbent must have schedule flexibility to occasionally work outside of standard 8:00AM- 5:00PM weekday hours. The position occasionally requires travel to other, local UW locations.
Appointment Type, Duration:
Ongoing/Renewable
Minimum $48,000 ANNUAL (12 months) Depending on Qualifications The starting full time salary for the position is $48,000 but commensurate with experience and qualifications. Actual pay is determined at hire and is based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at ( https://hr.wisc.edu/benefits/ ).
Additional Information:
Applicants for this position will be considered for the titles listed in this posting. The title is determined by the experience and qualifications of the finalist. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work.
How to Apply:
To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience.
Amanda Joncas [email protected] 608-262-2716 Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.
Official Title:
Clin Res Coord I(RE015) or Clin Res Coord II(RE016)
Department(s):
A53-MEDICAL SCHOOL/RADIOLOGY/RADIOLOGY
Employment Class:
Academic Staff-Renewable
Job Number:
The university of wisconsin-madison is an equal opportunity and affirmative action employer..
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Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center. (20%) Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. (20%)
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DESCRIPTION. Under supervision, the Research Associate will play a critical role in the successful execution of two distinct research studies: one focused on Gulf War veterans to investigate Gulf War Illness and another focused on East Palestine, OH residents affected by the 2023 train derailment.
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Job Summary: The Department of Radiology, University of Wisconsin - Madison, School of Medicine & Public Health is seeking a Clinical Research Coordinator (CRC) to help advance exciting medical imaging and disease-focused projects! The CRC works as part of a team, which includes physicians, PhD researchers, imaging staff, and other research support staff, to support and advance a portfolio of ...
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