Regional Director, Clinical Operations

Description

Regional Director, Clinical Operations

The Regional Director, Clinical Operations position is responsible for the developmental, operational, and performance oversight of assigned ObjectiveHealth Research Centers.

Who We Are

ObjectiveHealth is a clinical research company that uses proprietary technology to:

• Increase patient access to research trials within our communities,

• Provide physicians with enhanced care options for current patients, and

• Deliver superior clinical research enrollment metrics to Pharma sponsors.

All with the goal of Improving Patient Outcomes at the point of care.

We want you to join us in doing just that.

Essential Functions

• Provide quality, operational, and performance oversight for assigned Research Centers.

• Provide quality oversight of all sites to ensure that procedures are conducted according to clinical Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Provide quality, operational, and performance oversight for assigned Research Centers.

• Provide quality oversight of all sites to ensure that procedures are conducted according to clinical trial protocols; sponsor instructions; established company policies and procedures; all applicable state and federal regulations; Good Clinical Practices (GCPs); and ICH/FDA guidance including but not limited to the oversight of each site's Delegation Of Authority, Informed Consent Form and Investigational Product practices and compliance.

• Provide quality oversight to ensure all sites and staff members are compliant with ALCOA-C guidelines, Data entry timeline requirements and CRIO QC comment resolutions.

• Oversee assigned sites Regulatory documentation and compliance to SOPs

• Manage resource allocation and site level outcomes for each site including but not limited to QC, Regulatory, ObjectiveConnect and Travel resources.

• Manage staff hires, onboarding and training to ObjectiveHealth standards and assisting in ancillary business development for assigned research sites.

• Assume ownership of short- and long-term Research Center operational goals, quality performance, staff performance, and clinical trial enrollment goals. Responsible for tracking, monitoring, reporting, and managing with regards to these metrics.

• Assign and delegate staff as appropriate to serve as study champion for each trial, drive sponsor communication and own enrollment goals

• Guide staff in the achievement of established Research Center goals and assist them with adaptation in the event of changing priorities.

• Communicate performance standards and expectations to Associate Directors, Site Directors, and other Research Center staff.

• Support strategic and tactical plan for Research Center growth.

• Meet with Investigators and executive management as needed, to assess performance of the Research Center and provide recommendations regarding specific actions and process improvements that are aimed at improving Quality and efficiency.

• Maintain a consistent research presence in the partner practice.

• Work with Research Center staff to address quality, clinical, operational, and research-related issues as they arise. Handle and/or diffuse challenging situations in a professional manner while maintaining a positive outlook.

• Ensure that study-specific processes are communicated appropriately to ensure consistent application across all participating Research Centers.

• Assist in the completion of Business Agreements, as needed.

• Organize resources and establish priorities, including prioritizing and scheduling work assignments.

• Organize, lead and/or participate in any site, company, or study-team, meetings as needed

• Lead communication between investigators, ancillary partners, physicians, sponsoring organizations, and/or regulating bodies while ensuring HIPAA regulations are followed.

• Review scientific literature, participate in continuing education activities, and/or attend conferences/seminars in order to maintain and enhance industry knowledge.

• Maintain strong understanding of human subject protections and IRB operations.

• Can sit anywhere in the US - Travel to research sites required

Required Experience

• Bachelor's degree, Certification as an RN, or equivalent

• 5+ of experience in clinical research

• Experience in Site Director or equivalent Research Center leadership role

• Experience in employee supervision, leadership, training and development, and performance management

What We Offer

Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.

Requirements

This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant. If hired, candidate must be able to perform the duties of the position with or without reasonable accommodations. If you require an accommodation for the application process, please reach out directly.