Clinical Research Operations Manager

General Description: Responsible for managing all activities associated with the day to day management of CGT Clinical Operations; personnel and resource management and must ensure that all operations related to the implementation and execution of clinical research projects, programs, business, and departmental training/compliance functions meet all protocol obligations while following applicable regulations; Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental/institutional standard operating procedures. In partnership with the Administrative Director, the Clinical Research Operations Manager ensures all patients involved in a clinical research trial in CGT Operations are managed uneventfully, safely, and as effectively as possible through their episode of care and participation in the clinical research trial, ensuring patient care is not compromised while participating in a clinical research trial.

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Essential Job Functions

Directly responsible for the management and oversight of clinical research with the clinical research/inpatient/outpatients spaces and all clinical research projects conducted to ensure compliance with all applicable hospital and research regulations and policies, protection of human subjects, high quality data collection and effective study enrollment and completions responsive to all investigators within the Center for Gene Therapy in assisting with the development of their clinical research pipeline.
• Manages all human and physical resources associated CGT Clinical Research Operations. Works with the GCT Training/Compliance and Regulatory Teams on the development and implementation of quality and training standards for clinical operations staff; Responsible for planning and assigning staff to various studies, making organizational and/or resource adjustments as appropriate; Ensures adequate level of staff training to meet performance and quality standards; Responsible for hiring, performance evaluations and firing of clinical research operations staff in coordination with Team Leads.
• Provides guidance/oversight to clinical team members in all aspects of clinical study coordination as well as patient safety; troubleshoots clinical study issues including those issues that have operational, compliance and/or regulatory impact
• Collaborates closely with the CGT Administrative Manager to develop clinical trial budgets as well allocate the received funding per the contractual obligations, institutional policies and federal regulations. This includes costs associated with patient care, staffing efforts and other associated trial costs.
• Assists investigators and clinical research staff in planning, implementing, educating and evaluating care plans using Evidence-Based Practices in accordance with the requirements of the study protocol.
• Works closely with CRS administrative and clinical staff as well as Drug Development and Device Services and Research and Corporate Compliance to ensure that all internal and external QA/QC procedures are followed within the CGT Clinical Research Operations team.
• Works with Director to provide assistance to investigators with the development and feasibility of research proposals; working to write an effective proposal/protocol with all necessary components; review and make suggestions for revision; Works with Team Leads to complete feasibility assessments, projected staffing assignments and track new project activity and enrollment for CGT clinical research operations.
• Maintains current knowledge of federal, local and institutional hospital and research regulations by serving on hospital committees, reviewing current publications and attending conferences; Advises department leadership of regulation/policy changes and projected impact to clinical research operations. Note: Regular, reliable and consistent attendance is an essential job function. Employees are expected to perform work as scheduled. Please see the physical requirements for this position listed below.

Knowledge, Skills & Abilities: Education Requirement:

• BA/BS degree or equivalent experience in medical/science field. Masters preferred. Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Administrators or able to obtain within 6 months of hire Skills:
• Demonstrated in-depth knowledge of clinical research, IRB, and regulatory regulations, policies and procedures
• Strong verbal, written, interpersonal communication
• Goal-oriented; self-directive, initiation, self-motivation, creativity, flexibility
• Ability to lead others; positive attitude; excellent problem-solving skills, highly effective critical thinking skills
• Excellent organizational, attention to detail and prioritization skills
• Demonstrated effective conflict management; provides feedback in a constructive way
• Working knowledge of PCs, word processing, and data management software Experience:
• Five years of Clinical Research Operations experience.
• Minimum of 3 years personnel management experience required, five years preferred.
• Three to five years coordination experience required; past position requiring analytical and organizational skills to compile and analyze financial data; regulatory/IRB processes; experience managing multiple activities simultaneously.

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision. EOE M/F/Disability/Vet