Market Manager Clinical Research Operations, Central Coast CA Market

OverviewCommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources CommonSpirit is committed to building healthy communities advocating for those who are poor and vulnerable and innovating how and where healing can happen both inside our hospitals and out in the community.The CommonSpirit Health Research Institute, a beacon of medical advancement, offers comprehensive clinical research services and support for various research activities. Their primary focus includes multi-site clinical trials, local and large-scale data research, partnerships with industry and academia for technology and innovation research, physician-initiated research, resident-initiated research in teaching facilities, nurse-initiated research, and health sciences student-initiated research. By providing start-to-finish research services, they play a pivotal role in advancing medical knowledge and ultimately, patient care.While you're busy impacting the healthcare industry, we'll take care of you with benefits that include:Medical/Dental/Vision, FSA, Dependent Care Spending Account, Life Insurance, Short and Long-term Disability, 401k match, Paid Time Off, Wellness Program, Tuition Reimbursement, Accidental Insurance, Critical Illness Insurance, Identity Theft Protection, Employee Assistance Program, and more!ResponsibilitiesJ OB S UMMARY / P URPOSEThe Research Operations Research Market Manager (MRM) reports to the System Director Research Operations of CommonSpirit Health Research Institute (CSHRI), regarding all site operations, research engagements, and community research program development. This position will provide local leadership as well as day to day supervision for all clinical trials, research activities and site based clinical research staff within their assigned regional’ research sites. This position works closely with essential research constituencies Facilitates the general pre-award and post award clinical trial and research management workflow. Develops and establishes recommendations for changes in work operations.Essential Key Job Responsibilities

Serve as a central point of contact for and liaison to the research community to provide guidance related to the initiation and ongoing conduct of all research activity subject to CSHRI oversight.

Generate local support for research activities, including maintaining visibility with local leaders, physicians and other clinicians, and patients regarding research opportunities and portfolio.

Accountable for all site research activities including adherence to GCP guidelines, site timelines, quality control and assurance of research study data collection, clinical trial drug/device management, and research staff training and development.

Monitor site staff productivity, clinical trial enrollment and assignment of personnel resources to all research including new research activities.

Work with the study team and CSHRI Leadership to determine best practices for research operations and study budget accuracy.

Accountable to ensure timely data entry and tracking for both study and site information via the Clinical Trial Management System (CTMS) and other research tracking technology.

Manage site staff resource allocation within budgeted targets.

Promote a culture of individual accountability for quality assurance and improvement within the CRDM function and site research staff.

Function as content expert in developing appropriate training/educational materials along with the CSHRI Research Integrity function for all site teams.

Develop, implement and evaluate performance standards and measurements to support research coordinator and investigator compliance with protocol, GCP, FDA and other research regulatory requirements.

Support and promote:

Standardization of regional research operations.

Centralization of core research support services.

Clinical service line based research programs including Cardiology (Interventional Cardiology, Cardiac Surgery, and Electrophysiology), Oncology, Neurology, and other specialties.

Seek opportunities to collaborate with other CommonSpirit Health research facilities and sites to expand research program collaborations.

Participate in CSHRI research operations oversight and strategic planning activities as directed by CSHRI senior leadership.

Act as liaison between all members of the CSHRI community, including facility research leadership, CommonSpirit Health administrators, physicians/ Investigators, site research personnel , CommonSpirit Health Legal, CommonSpirit Health Corporate Responsibility, and CommonSpirit Health IRB, as well as between CSHRI and industry and government sponsors of research, and government agencies including the U.S. Food and Drug Administration (FDA). (Collaboration)

#LI-CSHQualificationsRequired Education and Experience

Minimum five (5) years of full-time experience in clinical trial management in a hospital and within an integrated health system.

Bachelor's required, SOCRA or ACRP certification required or must meet eligibility criteria to become certified within one year of hire.

Minimum three (3) years’ experience managing and supervising research staff

Demonstrated knowledge of Medicare coverage analysis and research billing compliance required.

Demonstrated knowledge of Federal (GCP, ICH), State and other research regulatory requirements required.

Previous experience with Clinical Trial Management Systems (CTMS).

Minimum of 2 years of experience in research contract and budget development and management preferred.

Pay Range$51.44 - $74.58 /hourWe are an equal opportunity/affirmative action employer.