Job Description

Job Description

Job Description

TITLE: Clinical Research Start-Up Coordinator

LOCATION: Newport Beach, CA (Onsite)

SCHEDULE: 8:30 AM – 5 PM

PAY: $90K - $97K Annual DOE

This is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position.

SUMMARY: Will support and participate in all study startup activities for the Center for Clinical Research within the hospital. 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.

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.
• 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.
• Maintains positive relationships with physician partners and practices mutual respects between hospital staff and our physician partners.
• Provides feedback in a way that facilitates improvement and growth.
• Takes time to mentor and support direct reports.
• Anticipates future trends and consequences.

SKILLS:

• 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.
• 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 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.

EDUCATION:

• Bachelor’s degree – required
• Must have three to five years of clinical research experience
• Must have completed 30-50 trails
• Must be able to work flexible hours/overtime to meet deadlines and requirements
• Must have previous experience with start-ups
• Master’s degree is preferred
• Project Management Professional (PMP) – preferred
• SOCRA or ACRP certification – preferred

Benefits: Medical, Dental, Vision, HSA, Employee Assistance Program (EAP), STD, LTD, Life and 401(K)

BAHAMA Consulting is an equal opportunity employer. If you need accommodation for any part of the application and hiring process or have any questions, please contact HR.

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