Clinical Research Manager - Heart Institute

Cincinnati Children's Hospital Medical Center Cincinnati , OH 45201

Posted 4 weeks ago

DEPARTMENT:The Heart Institute

SUPERVISOR'S TITLE: Senior Clinical Director Heart Institute and Director of the Heart Institute Research Core

TITLES SUPERVISED: Manager

  • Project Management; Research Utilization Consultant; Senior Specialist

  • Project Manager; Research Nurses; Clinical Research Coordinators; Data Management Specialist; Biostatisticians; Students; VolunteersTOTAL NUMBER OF FTE's DIRECTLY and INDIRECTLY SUPERVISED: 30 - 40

PURPOSE OF POSITION: Provide leadership; oversight; and assume responsibility for the daily operations and management of the Heart Institute Research Core (HIRC) in collaboration with the Director of the Heart Institute Research Core. Oversee the development; implementation and management of research productivity; internal processes and organizational capacity. Support growth of the HIRC and enhance its reputation by facilitating the design of research processes; implementation of research plans; dissemination and application of findings and the development of research professionals.

REPRESENTATIVE RESPONSIBILITIES

  • Strategic Planning

Establish and execute strategic objectives of HIRC in collaboration with the Director of HIRC and the HIRC leadership team. Provide, communicate, and implement strategic, operational and programmatic plans and policies to achieve the vision, mission, and values of CCHMC, the Heart Institute, and HIRC. Position HIRC to successfully develop as a national leader in clinical and translational research. Develop the necessary infrastructure and operational systems to increase and sustain high levels of research productivity. Lead the development and implementation of research systems and processes to improve HIRC overall productivity and efficiency and position HIRC for sustained growth by: Integration Management, Scope Management, Cost/Time Management, Communication, Research and Project Quality & Risk Management. Assist in the planning, design, measurement, assessment and improvement of services provided by HIRC. Collaborate with Heart Institute leadership and the Director of HIRC in short and long term strategic planning. Organize and conduct annual research needs assessment. Ensure the development of organization-wide materials, products and standards for communication about HIRC's results and activities (e.g., web site, informational materials).

  • Leadership

Work with Heart Institute faculty, functional and technical experts, and business director/managers to provide leadership for new project development efforts, including development of scope of work, budget and managing contract negotiations, and execution. Interact and communicate extensively with Institute leadership, sponsors and stakeholders: chair and conduct key customer meetings; facilitate HIRC project portfolio status reviews, and risk meetings with leadership. Keep stakeholders informed of progress and issues. Manage issues and risks, and resolve conflicts. Escalate issues and problems as necessary. Serve as a key resource to research staff and collaborators in the resolution of complex problems. Provide education to personnel through structured presentations and unstructured interactions. Provide teaching and mentorship in research and project management methodologies. Identify and assist in disseminating best practices through formal and informal methods. Support CCHMC business-related processes, procedures, best practices, and relevant applications. Produce financial, narrative and annual performance reports about HIRC's activities.

  • Operational Management

In collaboration with the Director, assume overall operational responsibility. Monitor, direct and perform day-to-day operations to ensure policies and procedures are being followed, objectives are being met and that services and projects are run efficiently and effectively. Plan, direct, schedule and manage resources and efforts of teams to support the operational needs and strategic objectives. Develop internal processes that will clarify roles and expectations, promote research collaboration, and enhance the education, development and productivity of HIRC professionals. Monitor timelines, milestone achievement and priorities. Analyze issues, take corrective action, and intervene when necessary. Monitor and respond to situations that affect daily operations. Develop and present reports and metrics to evaluate productivity, internal processes, the adequacy of organizational capacity, and funding utilization. Work effectively across the organization both internally across functional units within The Heart Institute and with other Divisions and Centers at CCHMC and externally with sponsor organizations and staff to ensure effective and efficient operational interface and coordination of management and technical decisions. Develop and improve operational processes, and manage complex operations.

  • Human Resources Management

Responsible for directing clinical and translational research support personnel. Manage the recruitment, selection, development, supervision, evaluation and discipline of reporting personnel. Make job requirements and goals for each position clear to employees and provide sufficient training to achieve the desired level of results. Document evidence of competence on an annual basis. Establish orientation, training and continuing education programs to ensure competency of staff. Administer the development of training plans for Good Clinical Practice, standard operating procedures by all staff and compliance with documentation of training. Collaborate with patient services to ensure integration and understanding of the complementary roles of clinical research and clinical management, including developing in-service materials for new hires.

  • Financial Management and Resource Planning

Collaborate with Heart Institute finance leaders to prepare, coordinate, evaluate and manage annual fiscal operating and capital equipment budgets. Conduct fiscal analysis and monitor fiscal utilization of scope of services. Forecast resource needs including planning for staff, space, IT support and all resources necessary for effective and efficient organizational structure to support clinical and translational research operations. Establish a robust informatics infrastructure in support of clinical and translational research. Participate in the selection of sources for necessary services not provided by Cincinnati Children's.

  • Research Management

Manage and direct the HIRC project portfolio. Facilitate the generation and maintenance of the HIRC Project Portal. Design and maintenance of the participant/research database and methods for document retrieval. Facilitate the preparation and review of research proposal(s)/grant submission(s). Monitor and maintain completion of Divisional Scientific Review and submission to sponsored programs office. Facilitate through the Managers of Project Management the preparation, review and approval of all study documents, agreements, contracts and reports. Facilitate systems and processes that will add with the logistics associated with study initiation- ordering/acquisition of study related supplies, coordination between internal or external departments or sites, training and instruction of the study team and ancillary staff, research registration and billing, maintenance of source documents and study binders. Ensure timeliness, availability and security of research information when exchanging information. Attend and participate in investigator's meetings as needed. Communication with sponsors concerning budget issues, research participant study-related problems, recruitment strategies and specific policies and procedures.

  • Compliance Management

Facilitate systems and processes for efficient preparation and submission of IRB documents and other documents required by regulatory agencies, conduct and summary of quality assurance and quality control checks. Facilitate the maintenance of study records in compliance with regulatory guidelines and monitoring of study team compliance with study procedures and standards. Facilitate the documentation and report of study events, adverse events, protocol violations, amendments and continuing reviews. Prepare for and respond to sponsor or regulatory audits. Facilitate proper documentation at study close-out as required by grant sponsor. Ensure the implementation of the Principal Investigator's recommendation for adverse event intervention and that serious adverse events are reported to sponsor and IRB and documented on source documents. Ensure compliance with regulatory agencies, adhering to GCP and Code of Federal Regulations guidelines, all applicable AAHRPP, JCAHO/ PHRP standards and serve as the departmental JCAHO representative. Act as a liaison between the research staff and the OCTR, industry sponsors, IRB, ORCRA, federal, state, and other regulatory agencies. Ensure adherence to grant sponsor, CCRF, IRB, and CCHMC accounting and grant administration guidelines.

EDUCATION/EXPERIENCE

Required:

  • Bachelor's Degree in healthcare or business related field

  • 5 years of experience in complex clinical and/or research environment

  • Progressive experience in operational and personnel management

  • RAPS, ACRP or SOCRA certification or equivalent within 18 months of hire

Preferred:

  • Master's degree in healthcare or business related field

Unique Skills:

  • Project Management

Ability to work independently to develop, implement and manage projects; knowledge of the principles and concepts of project management including proficiency with relevant project management tools

  • Prioritization

Using time efficiently and productively; prioritizing multiple tasks properly to meet deadlines; recognizing time constraints and adjusting work schedule to address them.

  • Independent Decisions

Willing and capable of independently making decisions

  • Teambuilding

Assembling teams of high-caliber people with diverse capabilities; fostering collaboration by laying down ground rules for team members, monitoring team members' interactions, and interceding when necessary to ensure team effectiveness; creating trust, a feeling of belonging to a team, and a desire for team accomplishment by showing respect for and empowering others

  • Collaboration

Working cooperatively with others to achieve group goals; proactively adjusting one's style and efforts to complement those of others on the team; being pleasant, agreeable, and easy to work with; valuing group success as much or more than individual success

  • Diversity Appreciation

Understanding and showing respect and appreciation for the uniqueness of all individuals; leveraging differences in others' perspectives and ideas; appreciating cultural differences and adjusting one's approach to successfully integrate with others who are different from oneself

  • Influence

Persistently shaping the thoughts and actions of others to achieve desired results; generating excitement and continuously striving to gain support for one's ideas, plans, or courses of action

  • Relationship Management

Setting the stage for constructive relationships by being accessible, approachable, and interpersonally engaged; developing and sustaining meaningful and productive bonds with others based on mutual respect

  • Strategic/Systems Thinking

Formulating credible, effective, long-range strategies to attain overarching organizational objectives; anticipating future trends, as well as potential threats or opportunities; accurately predicting how strategies will play out

  • Supervision

Ability to supervise others

  • Analysis
  • Basic

Analytical ability sufficient to evaluate data, make judgments and recommendations

  • Research Methods
  • Basic

Working knowledge of research methods including measurement, data collection and validity issues

  • Communication
  • Advanced

Excellent verbal, written and interpersonal communication skills.

Visa sponsorship not available for this position.


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Clinical Research Manager - Heart Institute

Cincinnati Children's Hospital Medical Center