Clinical Research Coordinator

#CA-SS

The Clinical Research Coordinator position will coordinate several clinical research projects in the Burn Surgery division. This individual will work under the general supervision of the Burn Surgery Clinical Research Supervisor and provides clinical research support to multiple PIs within the Burn Division and includes adult and pediatric research. Responsibilities include participation in the Burn Data Coordinating Center where intra and extramural multicenter trials are centrally managed, and data is submitted from multiple burn centers across the US and Canada. Data for these multicenter projects are captured centrally at the UCD Data Coordinating Center and remotely reviewed/validated for data quality and accuracy. Duties include coordinating clinical research projects, understanding protocol adherence and regulatory requirements, assisting in multi-site training programs, facilitating recruitment and screening, ensuring subject follow-up to maintain adherence with study timelines and protocols; collecting, documenting, and entering/reviewing study data. This includes study start up and close out procedures, assistance with financial aspects of clinical trials, FDA documents, HIPAA compliance, source documents and CRFs, laboratory specimen processing and shipping, and facilitating monitoring visits, etc. This individual will also be responsible for IRB and DoD OHRP preparation and submission, REDCap database project support, interfacing with diverse populations and across varied disciplines and health professionals while also maintaining patient confidentiality and following good clinical practice. Experience with program/project development/design and/or data/research presentation platforms preferred. This position is grant funded.

Apply By Date: November 14, 2024 at 11:59pm. Interviews and recruitment process may occur at any time.

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

Minimum Qualifications

• Prior experience as a Research Coordinator.
• Experience to independently comprehend and implement complex clinical research protocols, with careful attention and strict adherence to detail.
• Excellent mathematical abilities to perform basic accounting skills, calculate testing equations and perform statistical calculations.
• Experience coordinating a broad range of activities from inception to implementation within the confines of strict study protocols, University (or similar) and policies and procedures.
• Experience exercising integrity and discretion in all matters and protecting confidential information and/or protected health information as dictated by assignment, policy or regulation.
• Thorough knowledge and understanding of "Good Clinical Practices" for clinical research.
• Excellent skills to exercise discretion, initiative and resourcefulness and make independent judgments based on sound analysis.
• Experience in independently organizing tasks and setting priorities for work assignments to achieve timely progress on multiple tasks simultaneously, to meet deadlines and maintain a high level of productivity.
• Advanced level organizational skills and attention to detail in maintaining large volumes of records.
• Administrative skills and ability to exercise judgment, initiative and resourcefulness in making decisions.
• Excellent oral and written communication skills to clearly and concisely provide information, explanations and instructions to, and to elicit information from participants, participant's families, physicians, clinic staff and a wide variety of health care professionals with varying levels of ability to understand.
• Knowledge of anatomy, physiology, medical terminology and procedures to effectively interpret and accurately compile data according to study protocol.
• Advanced level computer skills for word-processing programs, database programs, and data management.
• Excellent writing and printing skills to clearly document research data onto forms and to prepare other IRB (or similar) documentation.
• Excellent interpersonal skills to communicate in a courteous, professional, effective and informative manner in person and on the telephone with a wide variety of people.
• Excellent skills in maintaining good working relationships with faculty, community-based healthcare professionals, staff and research participants.

Preferred Qualifications

• Familiarity with critically ill adult and/or pediatric populations and/or experience in burn surgery research strongly preferred.
• Advanced level knowledge and understanding of federal, state and university (or similar) regulations for clinical research under Investigational New Drug, Investigational Device and Institutional Review Board (IRB) guidelines (or similar).
• Experience to independently comprehend and implement complex clinical research protocols, with careful attention and strict adherence to detail.
• Experience coordinating a broad range of activities from inception to implementation within the confines of strict study protocols, University (or similar) and policies and procedures.
• Expertise using analytical and problem-solving skills for the identification and resolution of unique and unforeseen problems in a logical, timely, and often creative manner while maintaining the integrity of study protocols and legalities defined by the University (or similar) policies and procedures.
• Advance level skills preparing correspondence, recruitment materials, manuscripts, contracts and budgets.
• Excellent and advance knowledge use of grammar, punctuation and syntax for editing and proofing to produce error-free work.
• Excellent skills to communicate in writing using clear, expository prose.
• Excellent listening skills and intermediate to advance level skills to translate into a coherent written synopsis.
• Advance level understanding of the organizational culture of an academic/medical department in a large public university (or similar).
• Knowledge of personnel, travel, accounting and University policies, procedures, and systems preferred.
• College-level knowledge of human anatomy.
• College-level knowledge of medical terminology.

Key Responsibilities

• 80% - Clinical Research Coordination - Industry-Sponsored and Investigator-Initiated Research
  
  
• 15% - General Administration/Other
  
  
• 5% - Data Administration
  

Department Overview

The Department of Surgery encompasses a wide variety of surgical specialties. These include bariatric surgery, burn surgery, colorectal surgery, cardiothoracic surgery, gastrointestinal surgery, hepatobiliary surgery, endocrine surgery, pediatric surgery, plastic surgery, transplant surgery, trauma, acute care and surgical critical care surgery, vascular surgery, and oncologic surgery. The Department's extensive surgical expertise, in combination with ongoing teaching and research activities, provide ample resources and advanced surgical techniques for patient care.

POSITION INFORMATION

• Salary or Pay Range: $32.01-$51.48
• Salary Frequency: Hourly
• Salary Grade: 101
• UC Job Title: CLIN RSCH CRD
• Number of Positions: 1
• Appointment Type: Staff: Career
• Percentage of Time: 100
• Shift Hours: M-F, 8-5
• Location: Shriners Hospital for Children (OTH004)
• Union Representation: RX-Research Professionals
• Benefits Eligible: Yes
• Hybrid/Remote/Onsite: This position is 100% on-site
• This position 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

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