Apply for Vacancy for Operations Manager at Northwestern University in the USA. The category for this job is Health and Medical Services.
Manages all activities associated with highly complex biomedical &/or social-behavioral research studies including Investigator Initiated Trials, National Cooperative Group Trials with multiple affiliate institutions, and global Sponsored Trials which generate approximately 70-80 million dollars in revenue for the institution.
- Provides complex scientific & technical leadership in determining research priorities & the plan, design & execution of research projects ensuring that programs of investigation meet specified objectives.
- Also, directly involved with study start-up, implementation, conduct, and close-outs.
- Manages day to day activities of clinical research teams and oversees interaction with critical clinical partners such as pharmacy, nursing, pathology core, NMDTI, ect…
- Likewise, ensures that the conduct of study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.
- Trouble-shoots emergent patient care issues with clinical teams to ensure adherence to protocol guidelines, institutional reporting policies, and federal regulations.
- Moreover, leads clinical teams in preparing for internal CRO, NU IRB, Sponsor, and FDA audits.
- Also, oversees the timely completion of patient specific billing requirements to ensure hospital requirements for billing compliance is met.
- Oversees recruitment and management of clinical research staff.
- Additionally, completes applications and obtains appropriate approvals from various groups (CSRC committee, CRU, IBS, Pharmacy, etc.) for all necessary study-start-up functions.
- Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor’s or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years’ research study or other relevant experience required; OR
- Similarly, successful completion of a full course of study in an accredited college or university leading to a master’s or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 3 years’ research study or other relevant experience.
- Supervisory or project management experience required.
- Moreover, must complete NU’s IRB CITI training before interacting with any participants & must re-certify every 3 years.
- Clinical Research Coordinator Certification. If not currently obtained, will be required within 9 months of hire.
The incumbent must meet the following for Vacancy for Operations Manager in the USA:
- Excellent written and oral communication skills
- Similarly, strong organization and interpersonal skills.
- Moreover, computer expertise include being literate in Microsoft Office, Internet and database use.
- Nursing degree, Master’s or other graduate level degree or the equivalent of education, training and experience from which comparable skills can be acquired.
- Furthermore, past experience in hematology/oncology clinical trials preferred.
- Also, past experience working with clinical trials budget.
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