Clinical Research Coordinator, Neurosciences - 142053

UC San Diego; San Diego (CA); Sur place; USD 85 000 - 137 000; Plein temps

Résumé du poste

UC San Diego's Department of Neurosciences is seeking a Clinical Research Coordinator to manage start-up, recruitment, enrollment and subject maintenance across multiple phase I-III trials. You will coordinate with UCSD departments and external agencies to implement studies while ensuring regulatory compliance and data quality.

The role requires strong knowledge of clinical research processes, excellent communication, and the ability to guide investigators and staff through complex procedures in

Qualifications

• Experience in translational/clinical research and protocol start-up.
• Familiarity with IRB processes and regulatory guidance.
• Ability to manage multi-study coordination and data handling.
• Strong written and verbal English communication.

Responsabilités

• Coordinate start-up procedures, implementation, recruitment, screening, and enrollment.
• Maintain subjects and liaise with UCSD departments for study implementation.
• Oversee regulatory compliance and data quality across trials.
• Support PIs with proposals, progress reports and manuscripts.
• Provide education to investigators and staff on trial processes.
• Direct and coordinate operational efforts across disease teams.

Connaissances

Clinical research experience

IRB processes

Budget negotiations

Data management

Regulatory knowledge

Medical terminology

Independent judgment

Organization & prioritization

Communication skills

Formation

Bachelor's Degree (Biology/Science)

Outils

Microsoft Office

Description du poste

DESCRIPTION

The Department of Neurosciences is a large department within the UCSD School of Medicine, comprised of 17 FTE Faculty, 75 Salaried faculty, 60 Adjuncts (salaried and non-salaried), 25 Research and Project Scientists, 40 Postdocs, 25 Clinical Education, Administrative and Business Office staff with ~150 Research lab staff. Research revenues are ~$50M, Clinical revenue is ~$6M, Rady Children's revenue is ~$3.5M, VA Clinical Faculty Revenue is ~1.1M. Expansion is projected with the opening of the Jacob's medical center. The Department's faculty and divisions are sited on-campus in La Jolla and Hillcrest, Rady Children's Hospital - San Diego (RCHSD), and Temecula Valley. Working affiliations are also with Scripps Mercy Hospital and Medical Center. The Department's mission is to create the synergies and define the ideas and programs that allow to transform the way Neurosciences community discovers, teaches and cares. The Department of Neurosciences strives to deliver the highest quality clinical care to patients, conduct cutting-edge science and research and train the next generation of neurologists and researchers by fostering education at all levels and integrating the latest scientific and medicaladvances into the curriculum.

The Clinical Research Coordinator will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials.

MINIMUM QUALIFICATIONS

• Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.

• Demonstrated experience in translational/clinical research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

• Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in translational/clinical research including budget negotiations and invoicing per clinical trial agreement.

• Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).

• Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.

• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.

• Strong knowledge of investigational protocols especially with pediatric neurology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).

• Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.

• Strong experience completing clinical trials case report forms via hard copy and online.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology.

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience conducting searches on the internet.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

PREFERRED QUALIFICATIONS

• Knowledge of cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Possess a Clinical Research Coordinator Certificate, or Master's Degree.

SPECIAL CONDITIONS

• Rare evenings and weekends may be required.
• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check.
• Employment is subject to pre-employment physical for those who work in clinical settings and/or with patients.

Pay Transparency Act

Annual Full Pay Range: $84,940 - $136,555 (will be prorated if the appointment percentage is less than 100%)

Hourly Equivalent: $40.68 - $65.40

Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).