Clinical Research Coordinator

MED:Int Med Hemophilia Program

The Clinical Research Coordinator (CRC) will work in conjunction with the staff in the Research Hemostasis Laboratory, the Hemophilia Treatment Center, and the Division of Hematology and Oncology. The incumbent will coordinate with personnel associated with patient care and provide support and coordination for clinical trials and studies pertaining to patients with hematological disorders. The incumbent is responsible for all aspects of the clinical trial process from start to finish, including (but not limited to): clinical trial budget preparation, sponsor negotiation, IRB initial application, modifications, renewal, and closeout, FDA and other government regulatory compliance, audits, sponsor invoicing and ongoing monitoring of clinical trial protocols and compliance. The incumbent should be able to perform specimen preparation, data management activities, database management, patient scheduling/billing for research, GLP, and GCP. The CRC will provide quality customer service, demonstrate professional communication skills with excellent telephone answering skills, and have a willingness to work cooperatively as a team member. Required: the ability to work independently under minimal direction from the investigators, ability to work nights and weekends as required for pharmacokinetic studies time points, ability to demonstrate good typing skills, ability to follow through with subjects with rigorous time scheduling of clinical studies. The CRC is expected to lead and train incoming assistant CRCs. Must be able to move freely through the Hemostasis laboratory, UCDMC, Glassrock Pediatric Clinic, and CTCS and Cancer Center Clinics, IDS Pharmacy, and occasionally travel for investigator's meetings. #CA-SB

Apply By Date 12/5/2024 by 11:59pm

Minimum Qualifications

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

• IATA & 49 CFR Certificate. All departmental required certificate and training obtain within 90 days from date of hire
• IRB CITI training Laboratory Safety Training
• At least one year experience in all aspects of clinical trial from protocol review, patient enrollment, budgeting, sponsor negotiation, and study activities (including patient enrollment) through to the closeout of a trial.
• At least one year experience working on FDA requirements for human research and clinical trial; bench-based research or any performed based upon a protocol and schedule of events.
• At least one year of experience in specimen preparation.
• At least one year experience with data management activities and data management skills.
• Demonstrated mathematical abilities to perform calculations involving basic accounting, body surface area (BSA) calculations, and drug dosage calculations.
• Advanced level skills using Microsoft Word and Excel, as well as web-based program, and computer data and retrieval systems.
• Demonstrated 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 within required deadlines
• Demonstrated ability to clearly and accurately document research data on required forms.
• Demonstrate verbal communication and interpersonal skills to effectively communicate and correspond with the general public, co-workers, physicians, patients, caregivers, clinic staff, and other health care professionals.
• Strong customer service skills.
• Demonstrated ability to learn laboratory skills and apply proper safety use at all times while in the lab.
• Demonstrated ability to meet the scope of the program with general supervision and with frequent changes in priorities and deadlines.
• Demonstrated skills to evaluate information, practices, and procedures, formulate logical and objective conclusions, and make recommendations for effective solutions.

Preferred Qualifications

• Phlebotomy certification
• Demonstrated knowledge of basic anatomy and medical terminology.
• Experience with and knowledge of hemophilia, coagulation, and related disease processes as applied to clinical research is desirable.
• Demonstrated ability to work closely with caregivers and with patients who have a chronic coagulation disorder.

Key Responsibilities

• 40% - Regulatory Activities
• 40% - Clinical Research Activities
• 20% - Administrative Responsibilities

Department Overview

The HTC (Hemostasis and Thrombosis Center) is funded by the Center for Inherited Blood Disorders (CIBD), under the 340B federally funded Pharmacy Discount Program. Revenue received via patients purchasing Factor and/or other prescription drugs available through this program first pay for the cost of the drug, and any additional funds are allowed to be kept with UCDH for use by the HTC to support program growth, operations and goals

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: Five 8 hour shifts/week M-F
• Location: Ticon I (HSP087)
• Union Representation:Yes, RX-Research Professionals
• Benefits Eligible: Yes
• Hybrid/Remote/Onsite: This position is 100% on-site

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
• Pushing/Pulling 0-25 Lbs - Occasional Up to 3 Hours
• Pushing/Pulling 26-50 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 - Frequent 3 to 6 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 - Frequent 3 to 6 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

• Must be able to work flexible hours and overtime as required for pharmacokinetic studies. Must be able to travel on occasion, including weekends, and move freely through Hemostasis laboratory, UCDMC, Glassrock, university clinics, and Sacramento VA Medical Center. Must use own vehicle to move from clinic to clinic.

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