Senior Clinical Research Coordinator

The Senior Clinical Research Coordinator (Sr. CRC) for UCSF HDFCCC Breast Oncology department independently coordinates and is accountable for the overall administration of several clinical studies, typically requiring advanced-level knowledge and skills. They may provide leadership to lower-level clinical research coordinators and/or other support personnel.

The position is responsible for and critically important to the overall operational management of clinical research activities. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository. Positions at this level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.

Directly reporting to the Clinical Research Manager (CRM), the incumbent may have central responsibility in assisting the research team for study start-up and study implementation for pharmaceutical sponsored, cooperative group, and principal investigator-initiated studies. The Sr. CRC must exercise strong administration and management leadership of clinical research, strong research coordination, and may assist in leading less experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and implement quality improvement processes. The incumbent will also assist the Protocol Project Managers with regulatory approvals, budgeting, and study initiation, as needed and directed by the CRM.

Under the supervision of the CRM, the Sr. CRC position supports the clinical trial management of oncology trials.

Responsibilities include communicating with the lead program study coordinator to ensure aspects of study initiation of protocols are developed after regulatory and budgetary approval; and report study progress to the appropriate PI. The Sr. CRC may support studies with and without active patients as deemed appropriate by the CRM. The Sr. CRC may also lead the coordination of multi-site studies, where UCSF is the lead site. The incumbent supports the investigators in research study project management to assure compliance with the Code of Federal Regulation and the ICH Guidance on Good Clinical Practice as well as UCSF Institutional policies. The incumbent also supports the research team with additional duties as assigned by the CRM.

The position is a resource and teacher to other CRCs, contributes to the Cancer Center mission, manages more complex studies than the CRC, supports the CRM and fills in during absences. The Sr. CRC is knowledgeable about a variety of electronic databases; acts as a mentor and trainer, and assists with quality assurance activities.

50% Clinical Trials Management:
*Determine interest of groups in trial participation, assess ability to execute protocol safely and properly (analysis of infrastructure, staff, funding needs), create documentation, and ensure local and federal research law compliance.
*May be assigned up to 5 active studies that are complex and/or multi-site. For multi-site studies, coordinate issues and necessary documents across all sites.
*Coordinate studies across multiple departments (i.e. infusion center, pharmacy, laboratory, radiology), as well as the ability to coordinate data and specimen collection with non-UCSF sites.
*Act as a leading study coordinator if UCSF is lead study site, providing initial and ongoing training to
subsite coordinators. Assist Clinical Research Manager in ensuring continued compliance,
maintain study files, and audit readiness.
*Assist Clinical Research Manager and physicians in the recruitment of patients, track enrollment, discuss subjects' options, and ensure that documentation and storage of study files and supplies meet legal requirements.
*Properly document AEs, treatment compliance, and other related protocol outcomes in appropriate databases. Assist newly hired CRCs in this task, as well as serve as a leader during the Clinical Research Manager absence.
*Ensure that specimens are properly processed, stored, and shipped according to all laboratory policies and safety measures.
*Arrange the exchange of and transport of specimens with collaborating Investigators and staff.
*Oversee the incoming data interpreted from samples and ensure that it is correctly entered into respective databases, and reviewed by the Investigator
*Assist Clinical Research Manager and/or Protocol Project Manager for review and submission of protocols to Site Committee meetings. May assist with regulatory approval timelines for new studies in the queue.
*Assist Clinical Research Manager with proper close-out procedures for studies.
*Assist the Clinical Research Manager and/or Protocol Project Manager to coordinate new consent forms and protocol amendments to maintain the most up-to-date copies for the study team. May also assist in gathering relevant study documents, such as 1572, lab certifications, CVs, etc).
*Ensure optimal systems are in place to ensure compliance with regulatory requirements for the safe conduct of clinical research.
*Ensure reporting of protocol violations to study sponsors and reporting of adverse events to the CHR in a timely manner. May also provide regulatory affairs with updated renewal information for CHR renewals and IND annual reports, as needed.
*Respond to requests and reviews of studies from sponsors, study monitors, FDA, and other entities, including complex audits of study performance.

15% Staff Training:
*Assist the Clinical Research Manager and principal investigator in the recruitment and training of clinical research coordinators.
*Mentor clinical research coordinators and assistants, and help them successfully perform functions including but not limited to: recruitment, screening, scheduling, visit management, subject characterization, specimen processing, maintenance of regulatory documents, reconciling billing reports, and data entry.
*Train in federal and local research laws and guidelines.
*Assist in training new CRCs on various databases, including CHR (IRB database), iMEDris, and other relevant data reporting systems.
*Help manage personnel needs as assigned by the Clinical Research Manager.
*CRA Manual updated and lead SOP developer and updater
*Designated back up leadership when Lead is out of office or unavailable
*Manages team meeting schedule and CRC oncall schedule

30% Data and Financial Management:
*Manage subsite data submissions if UCSF is lead study site, creating data queries, clarifying, and
cleaning data when necessary
*Assist in monitoring the study budgets; manage invoices and reimbursements for protocol study
patients.
*Assist newly hired CRCs in using the billing tracking system (APEX, Oncore) by providing training as needed.
*Ensure billing is appropriate and accurate to avoid improper billing of Medicare, private insurance, or patients.
*Guide subjects through financial process (private vs. federal trials and their relationship to insurance reimbursement) to ensure accurate payments are made and subject not held responsible
*Review budget reports on a monthly basis.
*Along with the PI and Clinical Research Manager, create and maintain the annual study budget, monitoring all items posted on ledgers, and ensuring that future budget projections are consistent with remaining funds.
*Responsible for ensuring that the use of research funding is in compliance with funding agency protocols.
*Maintain and update all databases (i.e. Oncore).

5% Serve as a team player participating in assignments needed by the PI, Clinical Research Manager, and Research Personnel Manager.
This may include, but not limited to: participating in weekly team meetings; maintaining personal and common work spaces; cleaning and organizing study supplies; development of policies and procedure, and; other duties as assigned.

Requirements:

• Bachelor's degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.
• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills.
• Ability to analyze complex and non-routine issues requiring innovative solutions.
• Ability to operate effectively in a changing organizational and technological environment.
• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines.
• Ability to interpret and apply policies and regulations.
• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
• Experience using database software, such as MS Access or FileMaker Pro.
• Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire.

Preferred:

• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.
• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals

Requirements:

• Bachelor's degree in related area and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities and/or equivalent experience/training.
• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
• In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills.
• Ability to analyze complex and non-routine issues requiring innovative solutions.
• Ability to operate effectively in a changing organizational and technological environment.
• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines.
• Ability to interpret and apply policies and regulations.
• Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
• Experience using database software, such as MS Access or FileMaker Pro.
• Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire.

Preferred:

• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.
• Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals