Clinical Research Specialist I Jobs in Los Angeles, California

Experience may substitute for minimum education requirements

Basic education, experience and skills required for consideration:

Preferred education experience and skills:

Conducts protocol management for an assigned set of multiple research protocols.

Performs data management and data analyses, as required by the research study.

Identifies and communicates important protocol and data management issues or problem areas to supervisor.

Participates in required training and education programs.

1-year Clinical Research Related Experience

Join our team and use your skills with an organization known nationally for excellence in research!

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Participates in required training and education programs.

Understanding of general clinical research objectives. One (1) year of clinical research experience is preferred.

Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.

Must possess computer skills, including Word and Excel, and the ability to use standard office equipment is required.

Assists with clinical trial budgets and patient research billing.

Completes Case Report Forms (CRFs).

Participates in required training and education programs.

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Completes Case Report Forms (CRFs).

Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.

Participates in required training and education programs.

1 year of Clinical Research Related Experience preferred

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Completes Case Report Forms (CRFs).

Participates in required training and education programs.

Experience in a similar position is highly preferred.

Maintains the accuracy, integrity and security of complex, large computerized records systems.

Understands regulations, policies, protocols, and procedures to control and maintain accurate records.

Performs data searches and other related administrative tasks.

Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.

May implement and coordinate department-wide initiatives such as research quality management or clinical trial recruitment efforts.

Participates in required training and education programs.

Provides clinical research expertise by participating in the design and implementation of research projects as needed by the department or institution.

Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.

Coordinates research projects at an institutional or departmental level.

Communicates project status and improvement areas with leadership in a timely manner.

Participates in required training and education programs.

1 year Clinical Research Related Experience

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Completes Case Report Forms (CRFs).

Maintains all DSMC required documentation and ensures accurate recording of DSMC reviews into the clinical trial management system (OnCore).

Works with CCTO management to establish and optimize metric reports.

Assists in management of SOCCI Protocol Review and Management Committee by serving as a backup when necessary.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.

3 years of related experience in a similar position is required.

Prior monitoring or auditing experience in clinical research preferred.

Participates in required training and education programs.

Understanding of general clinical research objectives. One (1) year of clinical research experience is preferred.

Ability to interpret and apply knowledge of State, Federal and Agency standards to comply with regulations.

Must possess computer skills, including Word and Excel, and the ability to use standard office equipment is required.

Assists with clinical trial budgets and patient research billing.

Completes Case Report Forms (CRFs).

1 year of Clinical research related experience

Schedules patients for research visits and procedures.

Maintains accurate source documents related to all research procedures.

Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.

Schedules and participates in monitoring and auditing activities.

Experience in clinical site monitoring, site qualification, and site educational training

Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

3 years of previous experience with regulatory documentation for clinical studies, required

Experience in cardiac clinical research

Sponsor industry experience with clinical trial operations/research

Experience in Medical device trial

Hybrid remote work options are available but are subject to business needs and are not guaranteed.

Assists in the coordination with staff and outside agencies to obtain data; designs, organizes and develops research plans and evaluation designs.

Advises administrators of research findings and/or procedures; prepares narrative reports of findings with valid conclusions, projects program impacts, and predicts trends.

Riverside University Health System - Behavioral Health

• Demonstrated experience in establishing and maintaining effective relationships with management, peers and subordinates and customers.

5) What are the top 5 skills/requirements this person is required have?

• Manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges.

a. Required Skill 1: Organized and great attention to detail

b. Required Skill 2: Strong communication skills and intrapersonal skills

c. Required Skill 3: Takes initiative and works well alone and also within a team

Experience in site monitoring/central monitoring skills, site qualification, and site training

Data management experience or analytics

Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

3 years of previous experience with regulatory documentation for clinical studies, required

Experience in cardiac clinical research

Sponsor industry experience with clinical trial operations/research

2 years of related experience in supporting medical device clinical trials

Strong interpersonal and communication skills

Able to manage multiple tasks

Experience working directly with US and EU sites strongly desired

Experience working with clinical data and databases (desirable)

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation

Strong communication skills both verbal and written, report writing, and ability to meet deadlines

Good team member and experience in working in an office environment

LPN with current state licensure at the time of hire and three (3) years of related work experience

Experience working on a research study or clinic is preferred, but not required

Experienced with research coordination and teams

Ability to acquire and maintain all required CITI training certificates

2 years of related experience in supporting medical device clinical trials

Strong interpersonal and communication skills

Able to manage multiple tasks

Experience working directly with US and EU sites strongly desired

Experience working with clinical data and databases (desirable)

Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation

Supplemental Life, AD&D and Disability

Critical Illness, Accident and Hospital Indemnity coverage

Student loan servicing and support

Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members

Discount on services at Lurie Children’s facilities

Collaborate with management and research specialists to develop data collection methods,

Experience with statistical packages, such as SPSS or SAS.

Experience with independent research or being part of a research team.

**Benefits of working for the State of California**

Determine data sources and availability. Collect or extract data using a variety of established methods

Conduct all types of visits including, qualification, initiaiton, monitoring and close out

Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff

Ensure good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements

Minimum 1.5 years monitoring experience

Strong verbal and written communication skills

8-12 days on site per month

Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.

Demonstrated knowledge of how to synthesis study conduct.

Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.

Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.

Minimum two to three years’ experience in a clinical research or cancer registry environment with regulatory or human research protections.

Knowledge of clinical trials records, procedures, and computerized data processing systems. Demonstrated knowledge of how to synthesize study conduct.

Excellent computer and electronic database management skills.

Must possess excellent communication and interactive skills (both verbal and written), while also remaining flexible in responsibilities and work schedule.

Must maintain current certification for compliance and hazardous transport (IATA training).

Ability to multi-task and have good organizational and time management skills.

Experience in clinical research or the medical field preferred

Experience with Electronic Data Capture (EDC) systems, for the purpose of clinical research, preferred.

Experience with programming and coding (e.g., HTML and Java) required.

Possess excellent written and oral communication skills.

Critical thinking and problem-solving skills

Liaise with investigators, industry sponsors, and other study teams to ensure each clinical trial under your management operates efficiently

Willingness to positively adapt to changing environments, data systems, compliance requirements and general competing priorities from internal and external sources

Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.

Demonstrated knowledge of how to synthesis study conduct.

Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.

Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.

Bachelor’s degree plus 3-5 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection, or

Associate’s degree plus 5 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection, or

High School diploma/GED plus 7 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management, and/or data collection

Bachelor’s degree plus 5 years clinical research experience w/demonstrated proficiency in study planning/development, study coordination/management and data collection

Knowledge and skill with word processing, spreadsheet, database, and e-mail computer software (e.g., Microsoft Word, Excel, Access, Outlook)

UAMS offers amazing benefits and perks