Cbdi Clinical Research Ops Mgr

Johns Hopkins Medicine

2-5 years

Not Disclosed

Delhi

10 Sept. 18, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

CBDI (Cancer & Blood Disorders Institute) Clinical Research Operations Manager

Johns Hopkins All Children's Hospital is a leading clinical and academic health system, specializing in expert pediatric care for infants, children, and teens facing complex medical challenges. Ranked among the top hospitals by U.S. News & World Report, we provide access to innovative treatments and therapies. Our teaching hospital has over half of its 259 beds dedicated to intensive care services, making us the regional pediatric referral center for Florida's west coast. Physicians and community hospitals rely on us for critical care and complex surgical procedures.

What Awaits You?

Opportunities for career growth and development
Tuition assistance
A diverse and collaborative work environment
An affordable and comprehensive benefits package

POSITION SUMMARY:

The CBDI Clinical Research Operations Manager oversees a team of Clinical Research Nurses and Clinical Research Coordinators within the assigned unit. This role is responsible for managing day-to-day operations, staffing, human resources, and budgetary needs of the unit.

QUALIFICATIONS:

Bachelor’s degree with 5 years of clinical research experience required, including 2 years in a role as a Clinical Research Coordinator, Clinical Research Nurse, or providing nursing care to pediatric oncology research participants; OR a Bachelor’s in Nursing with 5 years of nursing experience and current Florida RN licensure.
Preferred: 2 years of experience with the Children's Oncology Group (COG).
Required: 2 years of supervisory or management experience.
Strong knowledge of Good Clinical Practice (GCP) guidelines, HIPAA, FDA regulations, and other federal guidelines.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Ability to follow protocols meticulously, with a strong understanding of the rationale behind methods used and attention to detail.
Expertise in medical terminology and human subject research.
Proficient in reading, writing, speaking, and understanding English.

Important Notices:

COVID-19 Vaccination Requirement: As of January 1, 2022, full vaccination with an FDA-approved COVID-19 vaccine is required for employment, with exceptions for religious or medical reasons. Effective June 1, 2023, the COVID-19 vaccination is not mandatory for employees or Florida residents.
Work Authorization: Applicants requiring current or future sponsorship will not be considered for this position.

Johns Hopkins Health System and its affiliates are Equal Opportunity/Affirmative Action employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, disability, genetic information, veteran status, or any other status protected by law.

Johns Hopkins Health System is a drug-free workplace. We are committed to maintaining a healthy and safe environment for our patients, visitors, and staff. Smoking is prohibited on campus, and employees must refrain from using tobacco products during work shifts, including breaks and lunch periods.

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