Clinical Research Associate

5 days ago

Newport Beach, United States Integrated Resources, Inc ( IRI ) Full time

. This role will collaborate with key stakeholders to ensure all aspects of the study startup process are met including activation timelines, facilitation and communication with internal and external stakeholders.

Essential Responsibilities:

-The Start-Up Coordinator will work closely with the Start-Up Program Manager to support the maintenance of the inventory of status throughout the startup process until internal study activation is granted. This includes working with study teams to closely track and review timelines and key milestones during the start-up phase.

-This role will support site start-up activities including but not limited to the review, collection and finalizing of Confidentiality Disclosure Agreements Clinical Trial Agreements, Material/Data Transfer Agreements and Disclosure Agreements. This includes corresponding with and providing site level information to sponsors including information about HCCR's feasibility process, SQV's, initial site documentation, budget negotiations, regulatory, and training, etc.

-This role will interface works closely with sponsors and internal teams to provide the necessary documents/information to meet internal timelines, including studies identified as Rapid Activation trials.

-This role will support HCCR leaders in identifying and mitigating obstacles for efficient and reduced study activation timelines.

Position-Specific Duties:

-Facilitates and efficient review and execution of clinical trial contracts/agreements.

-Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.

-Communicates project status and improvement areas with leadership in a timely manner.

-Supports the implementation of department-wide initiatives such as research process improvement efforts.

-Participates in required training and education programs.

-Participates in weekly research staff meetings.

-Accommodates and adapts to change as environmental, organizational, workload, task, direction and other conditions change in a constructive and positive manner.

-Manges conflict, disagreement and discord among and between staff and work units while recognizing and addressing sensitivities and stakeholder needs.

-Demonstrates ability to work with a diverse group of people in a manner that enables them to reach their full potential, in pursuit of organizational objectives.

-Fosters energy, enthusiasm, commitment, and an environment where people want to excel.

-Demonstrates respect for diversity in people, ideas and backgrounds.

-Aligns actions with Client's Mission, Vision and Values.

-Maintains positive relationships with Client's physician partners and practices mutual respects between hospital staff and our physician partners.

-Provides feedback in a way that facilitates improvement and growth.

-Delegates responsibilities to build team capability and manage workload.

-Selects and grows talented individuals.

-Empowers others with the authority they need to be successful.

-Identifies and supports development initiatives and opportunities.

-Takes time to mentor and support direct reports.

-Recognizes and rewards people for excellent performance.

-Anticipates future trends and consequences.

*Please see attachment for full job description.

Required Skills & Experience:

-The Clinical Research Department is seeking a detail-orientated clinical research leader with five or more years of clinical research experience.

-At least four years of experience in clinical research regulatory processes.

-Previous experience working with commercial IRBs.

-In-depth understanding of current medical terminology specific to oncology.

-Knowledge of patient electronic medical systems and CTMS or similar system.

-In-depth understanding of current medical terminology specific to oncology.

-Familiarity with FDA's Good Clinical Practice for clinical research.

-Knowledge of all components of clinical trials/studies.

-Ability to travel to multiple sites and attend off-site staff meetings, as needed.

-Maintains knowledge of technology, tools, equipment and other devices in work area.

-Demonstrates competence in technology skills required for this role, as well as ability to learn and master new skills.

-Possesses the ability to listen and understand what others are saying in a diplomatic and neutral manner.

-Establishes effective working relationships with others, contributing to a climate of mutual respect and cooperation.

-Demonstrates sensitivity and tact, understanding own effect on the motivation, attitudes and actions of others.

-Makes favorable first impressions.

-Demonstrates full knowledge and understanding of concepts and procedures needed to be successful in the role, including knowledge of applicable department, organization and external rules and regulations impacting day to day processes.

-Effectively manages people, resources, deliverables, budgets, general administration and other components of day-to-day management of functional unit or department.

-Ability to speak and write effectively, demonstrates fundamental command of language, communicates well using all mediums.

-Position may require local travel between various Organization locations.

Preferred Skills & Experience:

-N/A

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