Clinical Research Coordinator
This position will serve as a key team member of the clinical research function in the Department of Pediatrics. Clinical Research Coordinators (CRC) provide support, coordination and leadership for investigator-initiated research, industry sponsored clinical research, and government sponsored clinical research. These positions ensure efficient and accurate progress of clinical studies from the planning and approval stages, through study completions and post-study closure.
About the role
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(s), facilitate continued patient participation; extract data from medical records and other sources; collect, submit, and maintain study data and related regulatory documents; develop and ensure compliance with study protocols; and participate in the planning, development, and budgeting of clinical research studies. Under the direction of Principal Investigators, the incumbent is responsible for daily study activities and plays a key role in efficient study conduct and management. The incumbent is responsible for organizing the documentation and files pertaining to such 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(s) of clinical research studies.
Responsibilities
- Manage clinical trials (70% of role)
- Provide regulatory and administrative support for clinical trials (30% of role)
Requirements
- High school diploma, GED or equivalent experience
- Experience working as a Clinical Research Coordinator or in a comparable clinical research role involving the coordination of research studies, participant recruitment, regulatory compliance, data collection, and study documentation
- Experience working individually and as a team member in a diverse workforce
- Experience with databases, electronic data capture systems, medical record systems, Microsoft Word, Excel, and associated software
- Demonstrated oral communication and interpersonal skills for effective, positive, and congenial interactions and correspondence with the general public, co-workers, physicians, patients, caregivers, clinic staff, PIs, and other health care professionals
- Demonstrated administrative skills and ability to exercise good judgment, initiative, and resourcefulness in making decisions
- Demonstrated knowledge of regulatory processes and guidelines as well as a working knowledge of data management activities
- Demonstrated knowledge and skills to coordinate, direct, and follow through in the overall administration and outcome of one or more clinical research studies
- Demonstrated ability to display organizational skills and attention to detail to ensure that large volumes of records and data can be accurately maintained
- Demonstrated ability to multi-task, prioritize work as necessary, and proactively communicate status of work
- Advanced analytical skills to evaluate information, practices, and procedures, formulate logical and objective conclusions, and make recommendations for effective solutions
- Demonstrated writing skills to compose reports and correspondence while utilizing correct grammar, spelling, and punctuation as well as clearly documenting research data onto forms, and with attention to detail
Qualifications
- Society for Clinical Research Associates (SOCRA) Certified Clinical Research Professional (CCRP) or Association of Clinical Research Professional (ACRP) Certified Clinical Research Coordinator (CCRC)
- Previous experience working in Pediatrics
- Previous experience coordinating industry sponsored trials
- Advanced-level knowledge of basic anatomy, medical terminology, and ability to interpret physicians' notes, medical records, and laboratory and scan results
- Demonstrated knowledge of and regulations related to FDA, state, and federal guidelines, and Good Clinical Practices, for drug and device studies (clinical research involving human subjects)
Pay
$36.35 - $58.45 per hour
Schedule
Full-time (100%), 8-hour shifts. This position is hybrid (mix of on-site and remote work).
Benefits
- High quality and low-cost medical plans to choose from to fit your family's needs
- UC pays for dental and vision coverage for you and your family
- Retirement plans for eligible employees including Pension and other Retirement Saving Plans
- Supplemental insurance offered including additional life, short/long term disability, pet insurance, legal coverage, accident, critical illness and hospital indemnity
- Pregnancy and Parental Leave, Family & Medical Leave, Adoption Assistance and Pay for Family Care and Bonding for eligible employees
- Lactation Support Program and Family Care discounts and resources
- Employee Well-being resources and programming to support thriving in all aspects of employee’s lives
- On-site Employee Assistance Program including access to free mental health services
- Generous amount of paid Holidays annually
- Paid Time Off/Vacation/Sick Time as outlined in the UC Policies or Collective Bargaining Agreements
- Continuing Education (CE) allowance and Staff Education Reimbursement Program for eligible employees
- Access to free professional development courses and learning opportunities for personal and professional growth
- Public Service Loan Forgiveness (PSLF) Qualified Employer and Student Loan Debt Counseling Program for eligible employees
Physical Demands
- Standing: Frequent (3 to 6 Hours)
- Walking: Frequent (3 to 6 Hours)
- Sitting: Frequent (3 to 6 Hours)
- Lifting/Carrying 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
- Loud noise levels: Occasional (Up to 3 Hours)
- Marked changes in humidity or temperature: Occasional (Up to 3 Hours)
- Uneven Surfaces or Elevations: Occasional (Up to 3 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: Occasional (Up to 3 Hours)
- Multiple Concurrent Tasks: Frequent (3 to 6 Hours)