Senior Clinical Research Coordinator

UCSF•San Francisco, CA

23h

About The Position

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.

Requirements

Advanced-level knowledge and skills in clinical research coordination.
Sophisticated medical knowledge base.
Substantial leadership skills.
Ability to work effectively with a variety of people and organizations at UCSF and elsewhere.
In-depth knowledge of specific programs.
Strong administration and management leadership of clinical research.
Strong research coordination skills.
Knowledgeable about a variety of electronic databases.
Compliance with the Code of Federal Regulation and the ICH Guidance on Good Clinical Practice.
Compliance with UCSF Institutional policies.

Nice To Haves

May provide leadership to lower-level clinical research coordinators and/or other support personnel.
May assist in leading less experienced personnel.
May assist the Protocol Project Managers with regulatory approvals, budgeting, and study initiation, as needed and directed by the CRM.
May support studies with and without active patients as deemed appropriate by the CRM.
May also lead the coordination of multi-site studies, where UCSF is the lead site.
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.

Responsibilities

Independently coordinates and is accountable for the overall administration of several clinical studies.
Provides leadership to lower-level clinical research coordinators and/or other support personnel.
Implements a diverse portfolio of research activities for one or more studies, including multicenter clinical trials, local investigator-initiated clinical trials, and programmatic clinical research activities.
Performs expert integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base and leadership skills.
Assists the research team with study start-up and study implementation.
Exercises strong administration and management leadership of clinical research and research coordination.
Leads less experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and quality improvement processes.
Assists Protocol Project Managers with regulatory approvals, budgeting, and study initiation.
Supports the clinical trial management of oncology trials.
Communicates with the lead program study coordinator to ensure study initiation protocols are developed after regulatory and budgetary approval.
Reports study progress to the appropriate PI.
Supports studies with and without active patients.
Leads the coordination of multi-site studies where UCSF is the lead site.
Supports investigators in research study project management to assure compliance with regulations and institutional policies.
Supports the research team with additional duties as assigned.
Acts as a resource and teacher to other CRCs.
Manages more complex studies than the CRC.
Supports the CRM and fills in during absences.
Acts as a mentor and trainer.
Assists with quality assurance activities.