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Study Initiation Specialist Jobs (NOW HIRING)

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Clinical Operations Specialist

Blue Bell, PA · On-site

Clinical Operations Specialist ICON is a global healthcare intelligence and clinical research ... As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring ...

ICON

Clinical Operations Specialist

Raleigh, NC · On-site

Clinical Operations Specialist ICON is a global healthcare intelligence and clinical research ... As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring ...

Icon plc

Clinical Operations Specialist

Raleigh, NC · On-site

Clinical Operations Specialist ICON is a global healthcare intelligence and clinical research ... As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring ...

Denali Health

Principal Investigator

Saint Louis, MO · On-site

Study Initiation & Communication: * Participate in study initiation meetings with the sponsor to ... Assistance in business development and maintenance of a network of physician specialists for ...

Kelly Services

Clinical Research Specialist

Irvine, CA · Hybrid

Clinical Research Specialist Hybrid - onsite every Monday, Wednesday, and every other Friday Pay ... Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through ...

Yale Cancer Center

... at time of study initiation, execution/maintenance and close out. Interprets and applies ... Assists with Regulatory Affairs Specialist study transfer activities for training, documentation of ...

Pharmaron

Clinical Informatics Specialist

Baltimore, MD · On-site

$24 - $30/hr

Clinical Informatics Specialist Salary Range: $24.00/hr. - $30.00/hr. Location: Baltimore, MD (On ... Confirms IRB approval has been obtained prior to study initiation and activation in ClinSpark.

Pharmaron

Clinical Informatics Specialist

Baltimore, MD · On-site

$24 - $30/hr

Clinical Informatics Specialist Salary Range: $24.00/hr. - $30.00/hr.Location: Baltimore, MD (On ... Confirms IRB approval has been obtained prior to study initiation and activation in ClinSpark.

CYNET SYSTEMS

Site Contracts Associate

Durham, NC · On-site

$39/hr

Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and ...

CellCarta

Clinical Study Specialist I

Naperville, IL · On-site

$55K - $73K/yr

Clinical Study Specialist I Are you a clinical operations professional who thrives on precision ... site initiation visits, close-out visits, and related action item follow-up. Acting as a central ...

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Regulatory Specialist II (Oncology)

Baltimore, MD • On-site

Johns Hopkins University
Colleges, Universities, and Professional Schools • 10K+ employees
Learn more about Johns Hopkins Universityexternal

$41K - $72K/yr

Full-time

Re-posted 12 days ago

Johns Hopkins University rating

8.0

Company rating: 8.0 out of 10

Based on 72 frontline employees who took The Breakroom Quiz

Job description

We are seeking a Regulatory Specialist II who will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. This role will serve as a central resource for faculty conducting clinical research.
Specific Duties & Responsibilities
  • Collaborate with the Research Nurse and/or Principal Investigator to ensure timely and accurate submissions to the IRB and study sponsors.
  • Obtain and prepare all required documents for new IRB submissions, including initial study submissions.
  • Oversee the smooth implementation of new clinical trials from study conception through activation.
  • Coordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation.
  • Collect all required regulatory documents from participating sites when JHU/JHM serves as the coordinating center, ensuring timely collection
  • Develop and maintain standard operating procedures (SOPs).
  • Support auditing and monitoring activities, including those involving external sites.
  • Act as a central resource for faculty conducting clinical research.
  • Prepare and manage required regulatory documentation, including financial disclosure forms, delegation logs, FDA Form 1572, and others.
  • Maintain an organized regulatory binder (electronic or physical), initiating with required documents and structured for ongoing updates.
  • Ensure prompt reporting of serious adverse events (SAEs) and protocol deviations in accordance with applicable regulations.
  • Track protocol submissions through the IRB and relevant subcommittees, identifying bottlenecks and implementing process improvements.
  • Attend and contribute to study start-up meetings.
  • Participate in routine and as-needed monitoring visits.
  • Assist in preparation for and follow-up of regulatory inspections and audits.
  • Other duties as assigned.

Minimum Qualifications
  • Bachelor's Degree.
  • Two years of experience in academic, government, or industry-based
  • Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Classified Title: Regulatory Specialist II
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri / 8:30a - 5p
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Onc Hematologic Malignancies
Personnel area: School of Medicine

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About Johns Hopkins University

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Gilman believed that teaching and research go hand in hand—that success in one depends on success in the other—and that a modern university must do both well. He also believed that sharing our knowledge and discoveries would help make the world a better place. In 145 years, we haven’t strayed from that vision. This is still a destination for excellent, ambitious scholars and a world leader in teaching and research. Distinguished professors mentor students in the arts and music, humanities, social and natural sciences, engineering, international studies, education, business, and the health professions. Those same faculty members, along with their colleagues at the university’s Applied Physics Laboratory, have made us the nation’s leader in federal research and development funding every year since 1979. That’s a fitting distinction for America’s first research university, a place that has revolutionized higher education in the U.S. and continues to bring knowledge and discoveries to the world.

Industry

Colleges, universities, and professional schools

Company size

10,000+ Employees

Headquarters location

Baltimore, MD, US

Year founded

1876

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