Senior Clinical Research Coordinator

Under general direction of Clinical Research Supervisor, the Senior Clinical Research Coordinator has an advance-level working knowledge of data management activities, excellent communication skills and ability to work in a team environment to independently coordinate, direct and ensure follow through for overall administration and outcome of multiple clinical studies. This position will include oversight and training of new or lower-level clinical research coordinators and/or other support personnel, coordinating research meetings and acting as a resource. This 100% position will work with the PIs, other department personnel, sponsors, and community physicians to support and provide guidance on the administration of the regulatory coordination, data management, compliance, patient navigation, personnel and other related aspects of oncology and transplant related clinical studies. This is a grant funded position.

Apply By Date 11/24/2024 by 11:59pm

Minimum Qualifications

• Certification by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP)
• IRB CITI training
• Laboratory Safety Training
• IATA & 49 CFR Certificate
• All departmental required certificates and training to obtained within 90 days from date of hire.
• Bachelor's degree in a science or related field, or an equivalent combination of education and experience.
• Five (5) or more years of Clinical Research experience.
• Three (3) or more years of experience working with a Clinical Trial Management System; Velos or Encore.
• Extensive experience in Industry Sponsored clinical trial processes; clinical and regulatory.
• Thorough knowledge of FDA and IRB regulations, ICH guidelines and current Good Clinical Practice (cGCP).
• Experience working with computer systems and databases, including Windows, Microsoft Office Suite, electronic medical records, and electronic data capture systems for clinical research.
• Extensive knowledge of FDA and IRB regulations, ICH guidelines and current Good Clinical Practice (cGCP).
• Must have extensive knowledge of clinical trial management.
• Communication skills to convey factual information; to engage in collaborative problem-solving and negotiation with staff and colleagues.
• Self-directed and able to work independently, meeting the scope of the program with minimal supervision and with frequent changes in priorities and deadlines.
• Ability to independently exercise judgment, initiative and resourcefulness in making decisions.
• Demonstrate oral communication and interpersonal skills to effectively correspond with the general public, co- workers, physicians, patients, caregivers, clinic staff and other health care professionals.
• Display organizational skills and attention to detail so that large volumes of records can be accurately maintained, and workload priorities can be determined in an appropriate way to accomplish a task or goal. Ability to multi-task.
• Ability to work cooperatively as a team in a diverse workforce.

Preferred Qualifications

• Three or more (3+) years of experience in stem cell or oncology clinical trials.
• Advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
• Advanced-level knowledge and understanding of oncology and disease processes as applied to clinical research.

Key Responsibilities

• 55% - CLINICAL TRIAL MANAGEMENT
• 35% - PATIENT ADVOCATE / NAVIGATOR
• 5% - CONTINUING EDUCATION
• 5% - REGULATORY
  

Department Overview

The UC Davis Alpha Stem Cell Clinic (ASCC) specializes in early phase, first-in-human trials. The Alpha Stem Cell Clinic is devoted to accelerating the translation of all types of stem cell and regenerative medicine research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel cell and gene therapy clinical trials and ancillary studies for a range of difficult diseases. The Sr. CRC is responsible for Regulatory and Data management of studies assigned. The Alpha Stem Cell Clinic is a wide-ranging collaboration with unique contributions launched by the California Institute for Regenerative Medicine (CIRM) through the Alpha Clinic and other grants.

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: Day
• Location: UCD Inst for Regenerative Cure (HSP041)
• Union Representation: RX-Research Professionals
• Benefits Eligible: Yes
• Hybrid/Remote/Onsite: This position is 100% on-site
• THIS IS NOT A H-1B OPPORTUNITY

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

This position will require an extended number of hours on the computer. General operational schedule 8-5 M-F but must be able to work a flexible schedule for patient needs. Occasional overtime and weekends may be required. Required travel for training and conferences. Walking to and from different sites on the Health System campus several times per day required.

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