Sr Clinical Research Coordinator

The Senior Clinical Research Coordinator is a health professional having an advanced-level working knowledge of data management activities, excellent communication skills and a willingness to cooperate as a team member. The position requires certification/pending certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals. Also required is the use of advanced-level knowledge and skills to independently coordinate, direct and follow through in the overall administration and outcome of one or more clinical studies. This position will provide leadership for a department-wide clinical research program, including overseeing lower-level clinical research coordinators and/or other support personnel. #CA-SB

Apply By Date 2/22/2025 by 11:59pm interviews may occur at anytime

Minimum Qualifications

For full consideration, applicants are encouraged to upload license, certification and/or educational degree if required of the position.

• Certification by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).
• Bachelor's degree in related area and/or equivalent experience/training.
• Minimum 4 years of experience coordinating clinical trials.
• Advanced knowledge of federal, local, and institutional regulations and policies (e.g., Food and Drug Administration [FDA], Office for Human Research Protections [OHRP], and Good Clinical Practice [GCP]) is essential.
• Advanced knowledge of regulatory processes as well as a working knowledge of data management activities as applied to oncology clinical trial coordination.
• Advanced-level knowledge and understanding of disease processes as applied to clinical research.
• Advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
• Demonstrated leadership skills or experience encompassing both training and ongoing coaching.
• Experienced with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.
• Working knowledge of databases and/or Clinical Trial Management System (CTMS).
• Analytical skills to evaluate information, changes in practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.
• Demonstrate oral communication and interpersonal skills to correspond effectively with the public, co-workers, physicians, patients, caregivers, clinic staff and other health care professionals.
• Ability to work occasional overtime as work demands and travel on occasions.

Preferred Qualifications

• Previous oncology-related clinical research experience.

Key Responsibilities

• 65% - Data Management
• 15% - Quality Assurance
• 15% - Portfolio Management, Training and Process Improvement
• 5% - Other

Department Overview

The UC Davis Comprehensive Cancer Center (UCDCCC) is a campus-wide multidisciplinary matrix organization whose mission is to reduce the burden of cancer among the diverse populations in our community and beyond through bidirectional engagement and transdisciplinary collaborations that enhance our understanding of cancer, inform new ways to prevent and treat cancer, and prepares a committed and inclusive workforce. The Office of Clinical Research (OCR) is the centralized office for clinical research operations within UCDCCC. The OCR services support the entire lifecycle of cancer-related clinical research protocols. These include support for development and implementation of clinical trials, quality control of clinical research operations, and training and education services.

Department Specific Job Scope

Under the supervision of the Clinical Research Supervisor (CRS), the Senior Research Data Coordinator (SRDC) supports the clinical research efforts of the Cancer Center by providing comprehensive data management for high complexity cancer-related protocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.

The incumbent is responsible for the timely and accurate collection and coordination of data submission to study sponsors ensuring quality control and leading to timely milestone payments. This includes responsibility for the compilation and transcription of research patient data and study-related information into case report forms (CRFs) into sponsor specific electronic data capture systems (EDC). S/he will work with the clinical research team to manage and collect accurate data, assist Principal Investigators, and study coordinators for all data management aspects of cancer-related trials.

The incumbent will serve as the data manager for Investigator-Initiated Trials (IITs), inclusive of the creation and maintenance of electronic data capture systems. The individual will serve as a liaison to sub-sites for multi-center IIT EDCs, creating data entry guidelines, verifying the accuracy of data entered into the EDC and working with data coordinators to resolve queries.

Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Team Committees (DTCs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The incumbent is responsible, under the direction of the CRS, to provide training and guidance to other research data coordinators, demonstrating best practices, and provides ongoing analysis of internal processes and provides recommendations for new policies and procedures to improve overall operational efficiency and customer service.

The incumbent is responsible, under the direction of the CRS, for acting as a team lead/subject matter expert within their assigned disease or focus area.

In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).

POSITION INFORMATION

• Salary or Pay Range: $38.85 - $62.47
• Salary Frequency: Hourly
• Salary Grade: 100
• UC Job Title: CLIN RSCH CRD SR NEX
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100%
• Shift Hours: Mon-Fri 8a - 5p
• Location: Facilities Support Srvcs Bldg (HSP068)
• Union Representation: Yes, RX-Research Professionals
• Benefits Eligible: Yes
• Hybrid/Remote/Onsite: This position is hybrid (mix of on-site and remote work)

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.

If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html

* High quality and low-cost medical plans to choose from to fit your family's needs
* UC pays for Dental and Vision insurance premiums for you and your family
* Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave
* Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
* Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
* Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
* Access to free professional development courses and learning opportunities for personal and professional growth
* WorkLife and Wellness programs and resources
* On-site Employee Assistance Program including access to free mental health services
* Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
* Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
* Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here
* UC Davis cares about building a community, which is why we provide resources to enhance diversity, equity and inclusion as well as Employee Resource Groups (ERGs) to support our staff

Physical Demands

• Standing - Frequent 3 to 6 Hours
• Walking - Frequent 3 to 6 Hours
• Sitting - Occasional Up to 3 Hours
• Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
• Lifting/Carrying 26-50 lbs - Occasional Up to 3 Hours
• Lifting/Carrying over 50 lbs - Occasional Up to 3 Hours
• Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours
• Pushing/Pulling 26-50 lbs - Occasional Up to 3 Hours
• Pushing/Pulling over 50 lbs - Occasional Up to 3 Hours
• Bending/Stooping - Occasional Up to 3 Hours
• Squatting/Kneeling - Occasional Up to 3 Hours
• Twisting - Occasional Up to 3 Hours
• Climbing (e.g., stairs or ladders) - Occasional Up to 3 Hours
• Reaching overhead - Occasional Up to 3 Hours
• Keyboard use/repetitive motion - Occasional Up to 3 Hours

Environmental Demands

• Chemicals, dust, gases, or fumes - Frequent 3 to 6 Hours
• Loud noise levels - Continuous 6 to 8+ Hours
• Marked changes in humidity or temperature - Frequent 3 to 6 Hours
• Microwave/Radiation - Occasional Up to 3 Hours
• Operating motor vehicles and/or equipment - Frequent 3 to 6 Hours
• Extreme Temperatures - Occasional Up to 3 Hours
• Uneven Surfaces or Elevations - Frequent 3 to 6 Hours

Mental Demands

• Sustained attention and concentration - Continuous 6 to 8+ Hours
• Complex problem solving/reasoning - Frequent 3 to 6 Hours
• Ability to organize & prioritize - Continuous 6 to 8+ Hours
• Communication skills - Continuous 6 to 8+ Hours
• Numerical skills - Occasional Up to 3 Hours
• Constant Interaction - Frequent 3 to 6 Hours
• Customer/Patient Contact - Continuous 6 to 8+ Hours
• Multiple Concurrent Tasks - Occasional Up to 3 Hours

Work Environment

• Position requires working closely with caregivers and with patients who have a terminal illness.
• Position may require working occasional overtime as work demands and to travel on occasion for training and educational purposes.

Special Requirements

• This is a critical position, as defined by UC policy and local procedures, and as such, employment is contingent upon successful completion of background check(s), including but not limited to criminal record history background check(s)
• This position is designated as a mandated reporter under CANRA and UC policy, and employment is contingent on compliance with applicable policies, procedures and training requirements

Diversity, Equity, Inclusion and Belonging

At UC Davis, we're solving life's most urgent challenges to bring a fuller, healthier, and more resilient world within reach. We grow from every challenge we take on and we don't just maintain - we improve. We recognize that creating an inclusive and intellectually vibrant organization means understanding and valuing both our individual differences and our common ground. The most comprehensive solutions come from the most diverse minds and you belong here. As you consider joining UC Davis, please explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education, and our latest efforts to outgrow the expected. The University of California, Davis is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

For the University of California's Affirmative Action Policy, please visit: https://policy.ucop.edu/doc/4010393/PPSM-20

For the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

Because we want you to be seen, our recruiting process at UC Davis fosters authenticity, diversity, and inclusion. Studies have shown that some people may not apply to jobs unless they meet every single qualification. Each unique role at UC Davis has a set of requirements and you could be perfect for this role, or you could be perfect for the next role! Don't meet all the requirements? We still encourage you to apply! #YouBelongHere