Clinical Research Coordinator Senior NEX

#CA-DK

This position will act as a key team member of the clinical research function in the Department of Orthopaedic Surgery. Clinical Research Coordinators (CRC) provide support, coordination and leadership for industry sponsored clinical research, government sponsored clinical research and investigator initiated clinical research. These positions ensure smooth, accurate progress of clinical studies from the planning and approval stages, through study completion and post-study closure. Incumbents prepare documentation for submission for review by the Institutional Review Board (IRB), recruit and screen study participants, coordinate the clinical treatment and follow-up care as it pertains to study protocol, facilitate continued participation; abstract data from medical records and other sources; collect, submit and maintain study data and regulatory documents; develop and ensure compliance with study protocols; and participate in the planning, development and budgeting of clinical studies.

Under the direction of Principal Investigators, the incumbent is responsible for daily study activities and plays a key role in the study conduct and management. The incumbent is responsible for organizing the documentation and files pertaining to studies and for coordinating activities of investigators and study participants. This position requires the use of skills to independently coordinate and follow through in overall administration and outcome of clinical studies.

Senior Clinical Research Coordinators have achieved professional certifications in Clinical Research and are expected to independently manage large complex studies. This level requires 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.

The incumbent will provide leadership for a department-wide clinical research program, including guiding and mentoring clinical research coordinators, associates, and/or other support personnel.

Apply By November 24, 2024 at 11:59 pm

Minimum Qualifications

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

• Society for Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) or Association of Clinical Research Professional (ACRP) Certified Clinical Research Coordinator (CCRC) within 12 months of hire
• Bachelor's degree in related area and / or equivalent experience / training.
• 2 years of experience in a related field.
• Experience and working knowledge of but not limited to: scheduling and medical record systems, Microsoft Word, Excel, Access and etc.
• Intermediate to advanced knowledge of regulatory processes as well as a working knowledge of data management activities.
• Intermediate to advanced-level knowledge of federal, local, and institutional regulatory guidelines.
• Thorough knowledge of and regulations related to FDA, state & federal guidelines, and Good Clinical Practices, for drug and device studies (clinical research involving human subjects).
• Intermediate to advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
• Intermediate to advanced analytical skills to evaluate information, practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.
• Administrative skills and ability to exercise good judgment, initiative and resourcefulness in making decisions.
• Writing skills to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.
• Knowledge of basic anatomy and medical terminology.
• Demonstrate oral communication and interpersonal skills for effective, positive and congenial interactions and correspondence 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 and proactively communicate status of work.

Preferred Qualifications

• Intermediate to Advanced-level knowledge and understanding of orthopaedics, orthopaedic diagnosis, disorders and treatments as applied to clinical research.
• Leadership skills and experience in mentoring less experienced staff.
• Intermediate knowledge of basic anatomy and medical terminology.

Key Responsibilities

• 60% - Clinical Trials Management
• 20% - Regulatory Administration and Support
• 20% - Clinical Trial Administration and Analysis
  
  

Department Overview

This position is with the UC Davis Health School of Medicine Department of Orthopaedic Surgery, an academic/clinical department, encompassing several sub-specialties, working to achieve excellence in patient care, teaching, research and public service.

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: Days
• Location: Ellison Ambulatory Care Center (HSP098)
• Union Representation: RX-Research Professionals
• Benefits Eligible:
• Hybrid/Remote/Onsite: This position is hybrid (mix of on-site and remote work)
• THIS IS NOT AN H-1B VISA 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

• Position may require working occasional overtime and traveling between local work locations, as work demands.

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