The Ohio State University
Clinical Research Manager - CCC | Clinical Trials Office
The Ohio State University, Columbus, Ohio, United States, 43224
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Job Title: Clinical Research Manager - CCC | Clinical Trials Office Department: CCC | Clinical Trials Office Position Summary Clinical Research Manager who will manage, develop and oversee the conduct of non-therapeutic clinical trials within OSUCCC Clinical Trials Office (CTO) under direction of the Assistant Director of Non-Therapeutics and the Clinical Trials Director. Responsibilities
Oversees planning, organization, implementation and execution of all non-therapeutic clinical research projects
Manages and supervises daily administrative, operational, research and patient care activities collaborating and communicating with faculty, administration, research staff and shared resources within James Cancer Hospital and OSUCCC as appropriate
Plans, directs, assigns and monitors team workflow, activities and productivity to ensure fulfillment of research goals
Communicates and collaborates with disease-specific Clinical Research Managers in order to coordinate clinic activity and staff oversight
Collaborates with the Assistant Director of Non-Therapeutics and Clinical Trials Director in hiring, supervising, training, scheduling and evaluating research personnel
Directly manages non-therapeutic research staff both remotely and in clinic
Develops and implements plans to meet requirements of new studies/protocols and ensures all requirements are met
Plans and leads non-therapeutic team meetings at which protocol activity and progress, resource allocations and productivity benchmarks are reviewed; provides feasibility assessments
Conducts quality assurance reviews of research processes and data
Collaborates with OSUCCC investigators and regulatory staff in the development, review, submission and implementation of research protocols
On a limited level, collaborates with the Assistant Director of Non-Therapeutics and principal investigator (PI) to develop, negotiate, implement and administer research study budgets
Reviews, monitors and approves expenditures to ensure appropriateness; manages and supervises recruitment, interviews, screening and enrolling of patients into research protocols
Develops, implements and oversees education of patients participating in study
Ensures appropriate patient care and follow-up according to protocol
Participates in writing and submission of manuscripts.
Assists in the operations of the Recruitment, Intervention and Survey Shared Resource (RISSR) within the Comprehensive Cancer Center.
Directly supports projects and investigators utilizing RISSR with protocol development, revisions, document creation, study design, study start-up, and logistics
Manages and serves as liaison to collaborative research projects internal and external to OSU
Assists with regulatory compliance and submissions to the Institutional Review Board at OSU and other/external boards, amendments, and responses as needed
Job Requirements
Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; 5 years of experience in a clinical research capacity conducting & implementing research projects required; experience in a progressively responsible administrative or management research capacity preferred; knowledge of clinical research regulations, guidelines & compliance issues required including Institutional Review Board (IRB) & federal or industry sponsor processes and requirements; ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required; supervisory experience preferred; knowledge of clinical trials data management preferred. Research and Scholarship - Clinical Research - People Leader - Managerial - M2 Manager Additional Information
As one of only 50 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies – providing tomorrow’s standard of care today. A Cancer-Free World Begins Here. Location: Optometry Clinic (1041) Position Type: Regular Scheduled Hours: 40 Shift: First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process. Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions. The university is an equal opportunity employer, including veterans and disability. As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression.
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Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application.
Job Title: Clinical Research Manager - CCC | Clinical Trials Office Department: CCC | Clinical Trials Office Position Summary Clinical Research Manager who will manage, develop and oversee the conduct of non-therapeutic clinical trials within OSUCCC Clinical Trials Office (CTO) under direction of the Assistant Director of Non-Therapeutics and the Clinical Trials Director. Responsibilities
Oversees planning, organization, implementation and execution of all non-therapeutic clinical research projects
Manages and supervises daily administrative, operational, research and patient care activities collaborating and communicating with faculty, administration, research staff and shared resources within James Cancer Hospital and OSUCCC as appropriate
Plans, directs, assigns and monitors team workflow, activities and productivity to ensure fulfillment of research goals
Communicates and collaborates with disease-specific Clinical Research Managers in order to coordinate clinic activity and staff oversight
Collaborates with the Assistant Director of Non-Therapeutics and Clinical Trials Director in hiring, supervising, training, scheduling and evaluating research personnel
Directly manages non-therapeutic research staff both remotely and in clinic
Develops and implements plans to meet requirements of new studies/protocols and ensures all requirements are met
Plans and leads non-therapeutic team meetings at which protocol activity and progress, resource allocations and productivity benchmarks are reviewed; provides feasibility assessments
Conducts quality assurance reviews of research processes and data
Collaborates with OSUCCC investigators and regulatory staff in the development, review, submission and implementation of research protocols
On a limited level, collaborates with the Assistant Director of Non-Therapeutics and principal investigator (PI) to develop, negotiate, implement and administer research study budgets
Reviews, monitors and approves expenditures to ensure appropriateness; manages and supervises recruitment, interviews, screening and enrolling of patients into research protocols
Develops, implements and oversees education of patients participating in study
Ensures appropriate patient care and follow-up according to protocol
Participates in writing and submission of manuscripts.
Assists in the operations of the Recruitment, Intervention and Survey Shared Resource (RISSR) within the Comprehensive Cancer Center.
Directly supports projects and investigators utilizing RISSR with protocol development, revisions, document creation, study design, study start-up, and logistics
Manages and serves as liaison to collaborative research projects internal and external to OSU
Assists with regulatory compliance and submissions to the Institutional Review Board at OSU and other/external boards, amendments, and responses as needed
Job Requirements
Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; 5 years of experience in a clinical research capacity conducting & implementing research projects required; experience in a progressively responsible administrative or management research capacity preferred; knowledge of clinical research regulations, guidelines & compliance issues required including Institutional Review Board (IRB) & federal or industry sponsor processes and requirements; ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required; supervisory experience preferred; knowledge of clinical trials data management preferred. Research and Scholarship - Clinical Research - People Leader - Managerial - M2 Manager Additional Information
As one of only 50 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies – providing tomorrow’s standard of care today. A Cancer-Free World Begins Here. Location: Optometry Clinic (1041) Position Type: Regular Scheduled Hours: 40 Shift: First Shift Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process. Thank you for your interest in positions at The Ohio State University and Wexner Medical Center. Once you have applied, the most updated information on the status of your application can be found by visiting the Candidate Home section of this site. Please view your submitted applications by logging in and reviewing your status. For answers to additional questions please review the frequently asked questions. The university is an equal opportunity employer, including veterans and disability. As required by Ohio Revised Code section 3345.0216, Ohio State will: educate students by means of free, open and rigorous intellectual inquiry to seek the truth; equip students with the opportunity to develop intellectual skills to reach their own, informed conclusions; not require, favor, disfavor or prohibit speech or lawful assembly; create a community dedicated to an ethic of civil and free inquiry, which respects the autonomy of each member, supports individual capacities for growth and tolerates differences in opinion; treat all faculty, staff and students as individuals, hold them to equal standards and provide equality of opportunity with regard to race, ethnicity, religion, sex, sexual orientation, gender identity or gender expression.
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