Senior Clinical Research Associate
Clinical Research Associate Job 41 miles from Redondo Beach
About the Company:
Humannity Medtec's Clinical Affairs team is currently accepting applications for a Clinical Research Associate II/III for a full-time position (hybrid) based in Valencia, CA. This position plays an essential role in the development and implementation of clinical research projects by supporting the clinical activities of assigned studies.
About the Role:
Responsibilities include the planning, execution and interpretation of clinical research and data collection activities. This position plays a key role in the development and execution of pre-clinical, First in Human and pivotal trials intended to support regulatory registration of novel medical devices, as well as physician-initiated and company-sponsored clinical trials.
Responsibilities:
Ability to autonomously manage all clinical activities related to the execution of US/OUS Class 3 medical device clinical trials consistent with GCP and other regulatory and compliance requirements.
Drive activities related to the execution of a clinical trial, from protocol study design to final clinical study reporting for one or more studies.
Support study efforts in collaboration with internal stakeholders as well as outside vendors involved in the clinical trials (e.g., central labs, CROs).
Assist Study Manager during study audits.
Along with other Clinical team members, contribute to and assist with the preparation of protocols and Case Report forms, finalization of monitoring and data management options (either in-house or contracted to a CRO), development of recruitment strategies, the provision of clinical trial materials, and trial management.
Support Study Manager in coordinating the smooth monitoring of all trials, establishing audit procedures and ensuring timely data processing.
Participate in the training of Field Clinical Engineers on study protocols.
Provide back-up support for preclinical studies and other projects, as needed.
Qualifications:
BS or MS degree in Life Sciences, Engineering or a related field. Active SoCRA or ACRP Certification. 6 or more years of experience in a CRA II/III role working with Class III Medical Device clinical trials (FIH, Pivotal, Post-Market) from start-up to close-out (preferably in Neuromodulation).
Required Skills:
Strong writing skills (emails, letters, reports, publications, independent and proactive internal and external communications, submission materials including synopsis, protocol, study reports).
Proven track record of effectively working with clinical sites.
Experience with Class 3 medical device BIMO audits, QC audits and QA check reports.
Experience working with Data Management on query resolutions.
Experience in reviewing email alerts for AEs, deviations, withdrawals, deaths and informing the Study Manager.
Experienced in reviewing clinical data and completing internal CRA analysis fields, classification of AEs and timely reporting of UADEs to Study Manager.
Experienced in planning and participating in investigator meetings, Steering Committee and DSMB meetings.
Excellent knowledge of clinical study guidelines (FDA, ICH and GCP).
In-depth understanding of the clinical trials process Trial Master File Management.
Understands technical details and seeks out opportunities for advancing technical knowledge.
Ability to utilize various electronic systems and software- intermediate computer skills required.
Ability to travel as required less than 20% as needed.
No Experience: High Paid Clinical Trials For Mental Or Physical Conditions
Clinical Research Associate Job 13 miles from Redondo Beach
If you are physically/mentally ill or healthy, get paid to trial new treatments and medications.
This is a great way to earn additional income, sometimes from the comfort of your home.
Participation in clinical trials can be a very rewarding experience. Not only do you get free access to cutting-edge medical treatment, but you are also contributing to science all whilst getting paid.
Some of the conditions we are currently recruiting for include:
Healthy participants
Migraines
Mental Health Issues
Alzheimer's Disease
Parkinson's
Skin Conditions/Eczema
Cancer
COPD
Diabetes
Crohn's
Children with Autism
..and many more
Compensation can be up to several thousand dollars depending on the trial.
No experience or education required.
Clinical Trials Manager
Clinical Research Associate Job 13 miles from Redondo Beach
Who We Are
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in oncology and autoimmune diseases. Our lead cell therapy asset is next generation CAR-T NXC-201 for relapsed/refractory AL Amyloidosis, and relapsed/refractory multiple myeloma, currently being evaluated in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial. NXC-201 has the potential to be the world's first “Single-Day CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients and supporting ongoing expansion into autoimmune indications. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma. Our second program, a tissue specific therapeutic (TSTx) asset IMX-110, is being evaluated in Phase 1b/2a clinical trials as a monotherapy and IMMINENT-01 combination clinical trial with BeiGene's anti-PD-1 antibody tislelizumab in relapsed/refractory solid tumors. IMX-110 has been awarded Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA.
Our team is made up of talented dedicated professionals working from our offices in Los Angeles, California and globally. At Immix, we hire exceptional people and unleash their abilities to do inspired work to develop new therapies for patients.
Our 3 Core Values
Intelligence
Integrity
Initiative
How You Will Contribute to Advancing Clinical Trials
JOB SUMMARY:
The Clinical Trial Manager is responsible for the ownership, accountability, and results of clinical trials. They provide project management to plan, prepare, and execute one (or more) clinical study(ies) from initiation to close out. The Clinical Trial Manager interfaces internally with team members and across functional teams and acts as a liaison with external vendors contractors, consultants. The Clinical Trial Manager is accountable for timeline development, communication, and study outcomes and milestones, and the delivery of trial(s) within quality parameters, timelines, scope, and budget.
Requirements:
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Implement, manage, and terminate clinical studies in accordance with the Protocols, Good Clinical Practices (GCP's), Standard Operating Procedures (SOP's) and other regulatory requirements.
Develop detailed plans, prioritize tasks, coordinate, and provide oversight of all elements of the clinical trial(s) to attain project deliverables, and achieve project goals within specified timelines and budget.
Communicate the status and progress of clinical trial(s), and raise issues related to study conduct including but not limited to: timelines, enrollment, and/or budget with study team members, functional teams, and management.
Develop and implement appropriate actions to address issues with clinical trial(s).
Provide oversight of project team members and deliverables, and ensure all necessary project-specific training is provided
Lead efforts to ensure on time development and appropriate distribution of study specific documents including study protocols, data management plans, statistical analysis plans, informed consent documents, case report forms, monitoring plans, study manuals, training plans and materials, and other study tools and plans.
Demonstrate thorough knowledge of and supervise others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
Participate in the development and implementation of internal policies & procedures to optimize management of clinical trials; contribute to process improvement.
Participate in the selection of, and management of issues related to study investigators, various clinical study contractors and vendors including contract research organization (CRO) staff, contract monitors (domestic and international), IRB/ECs, etc.
Review Monitoring Trip Reports provided by Monitors for all phases of clinical trial(s) including site evaluations, initiations, interim monitoring and close out visits.
Provide mentoring to junior staff and sites regarding protocols and site management.
Responsible for baseline timeline development and manage the study according to planned budget and timelines.
Oversee development and collection of site non disclosures, contracts and budgets.
Oversee site evaluations, activations, monitoring and closures to ensure on time delivery and act on any deviations from plan.
Help select and qualify clinical trial investigational sites.
Prepare, participate in and coordinate presentation of training materials to include study team member training, investigator meetings, Site Initiation materials and protocol training materials. protocols and other study requirements at study initiations at investigational sites when needed.
Lead preparation and execution of study meetings (e.g., kick off meetings, investigator meetings, periodic study team meetings, etc.) and ensure documentation in the form of agendas and minutes.
Develop and oversee the production and timely distribution of site binders.
Manage the development and implementation of patient recruitment and patient retention strategies and oversee and track study enrollment.
Participate in the development and review of Case Report Forms to ensure proper data is captured.
Oversee the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.
Assist Regulatory Affairs as needed to provide accurate and timely reports, such as annual reports or safety reports to the FDA and other regulatory bodies.
Ensure clinical project audit and inspection readiness through the study lifecycle and contribute to CAPAs as required.
Collaborate in the assessment of project risks and develop and implement study level risk management plans and reviews.
Oversee clinical trial(s) to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
Lead and coordinate the development of clinical study reports (interim, annual, and final) in collaboration with cross functional team members to support regulatory submissions.
KNOWLEDGE, SKILLS AND ABILITIES:
In depth understanding of ICH GCP Guidelines and other local or international guidance, regulation and codes of practice related to the execution of clinical trials, preferably ophthalmic devices.
Organizational awareness to operate in cross-functional teams and provide leadership to other clinical staff members.
Must recognize and commit to a sense of urgency, teamwork.
Ability to take and maintain initiative.
Possess strong interpersonal skills with the ability to manage and mentor others, interact with peers, medical professionals, consultants, and Regulatory Agencies as required.
Effective time management skills with the ability to plan, prioritize, organize, and problem solve independently with the use of critical thinking skills.
Outstanding oral and written communication skills to influence, inform or guide others.
EDUCATION AND EXPERIENCE:
Bachelors or master's degree within life sciences or related field.
3+ years clinical research experience including previous monitoring experience.
Prior experience (1-3+ years) in the planning, conduct and management of clinical trials, with strong preference given to ophthalmic device experience.
Current ICH GCP certification.
PHYSICAL REQUIREMENTS:
Must be able to remain in a stationary position at least 50% of the time.
Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
Ability to listen and speak with employees and external partners, stakeholders, etc. Must be able to exchange accurate information in these situations.
Occasionally lift up to 25 pounds. This may be performed with reasonable accommodation.
View and type on computer screens for long periods of time.
Immix Biopharma, Inc is an Equal Opportunity Employer and takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Rewards at Immix
Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.
Compensation will be commensurate with experience. Our compensation package also includes an annual bonus based on company goals and an equity grant. Our benefits package includes: coverage for medical, dental and vision for team members and dependents and 401k.
For more on our technology, culture, and team, go to *****************
Clinical Research Associate
Clinical Research Associate Job 13 miles from Redondo Beach
Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Los Angeles, California (CA). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization.
Responsibilities for the Clinical Research Associate:Conduct site and study visits and perform all site monitoring activities across multiple study Responsible for both remote and on-site monitoring and study activation Participate in the development of study tools, protocols, and clinical trial documentation Some travel required once travel bands are lifted Qualifications for the Clinical Research Associate: 2-4 years performing on-site monitoring and hands on experience with EDC SystemsExperience with Oncology is highly advantageous Organization to perform monitoring duties across multiple sites is a must Compensation for the Clinical Research Associate:Salary Range: $100,000-$120,000Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays#LI-SR1
Clinical Research Informatician
Clinical Research Associate Job 13 miles from Redondo Beach
***Local candidates only, hybrid, some onsite required.
· Campus or Medical Enterprise: Medical Enterprise
· Dress code: Business Casual
Must Haves:
Bachelor's Degree in Health Information Management, Health Informatics, or a related clinical field (e.g., nursing) with certification in Health Informatics, OR a B.S. in informatics, computer science, statistics, biomedical engineering, or artificial intelligence with certification in Health Informatics. ****(Required)***
(Preferred)
Master's Degree in health information systems or health informatics.
Minimum 2 years' experience in:
Clinical Research
Clinical Informatics
Information Technology and/or Academic Healthcare Settings
Experience with:
Clinical operations, Health Information Management, or Care Management
Clinical standards, coding, definitions, ontologies, dictionaries, and taxonomies
Clinical Key Performance Indicators (KPIs)
Implementing new technologies in clinical settings
Healthcare data curation and documentation in a data warehouse
Proficiency in:
SQL and Python or similar coding languages
Liaising between clinical stakeholders and technical teams
Expertise in:
Analyzing and optimizing clinical workflows to improve efficiency and patient outcomes
Summary:
The Clinical Research Informatician is a bridge between clinicians/researchers and data. They blend their knowledge of clinical workflow, terminology, and practices with an understanding of health information technology to advance clinical and translational research towards improved patient care. The Clinical Informatician will play an integral role focused on creating, testing, implementing, and maintaining applications and data for clinical areas. Responsibilities include acting as a liaison between clinicians/researchers and data stewards, interfacing with stakeholders on informatics software development, maintenance, and operations, and creating streamlined workflows for the exploitation of healthcare data.
Minimum Education
• Bachelor's Degree In Health Information Management or Health Informatics OR B.S. in clinical field (nursing, etc.) and certification in Health Informatics OR B.S. in informatics, computer science, statistics, biomedical engineering artificial intelligence AND certification in Health Informatics. Required
• Master's Degree preferred
Minimum Experience/Accountabilities
• Minimum 2 years' experience in clinical research
• Minimum 2 years' experience in clinical informatics
• Minimum 2 years' experience in information technology and/or in academic healthcare setting
• Experience with clinical operations, Health Information Management, or care management
• Experience with clinical standards and coding
• Experience with clinical definitions, ontologies, dictionaries, and taxonomies
• Experience with KPIs as they relate to clinical areas
• Experience implementing new technologies in clinical areas
• Collect, organize, curate, and document healthcare information within the data warehouse.
• Apply experience with clinical information and workflows to the development of informatics tools, applications, analyses, and procedures.
• Develop, modify, test, and implement applications and algorithms for the collection, organization, and analysis of healthcare data.
• Assist in the development of presentations, scientific publications, and grant proposals.
• Apply insights gained from research to improve patient care or healthcare operations.
• Ability to interact directly with and interpret healthcare data using self-service tools or coding languages, such as SQL and Python
• Ability to liaison between clinical stakeholders and Enterprise Data & AI technical team members
• Expertise in analyzing and optimizing clinical workflows, leveraging IT to enhance efficiency, accuracy, and patient outcomes through targeted interventions and system improvements.
• Collaborate with software vendors and IT service providers to ensure that their products and services are tailored to meet the unique operational needs of the healthcare facility, optimizing performance and compliance.
• Other duties as assigned.
Clinical Research Start-Up Coordinator
Clinical Research Associate Job 32 miles from Redondo Beach
TITLE: Clinical Research Start-Up Coordinator
SCHEDULE: 8:30 AM - 5 PM
PAY: $90K - $97K Annual DOE
.
SUMMARY: Will support and participate in all study startup activities for the Center for Clinical Research within the hospital. This role will collaborate with key stakeholders to ensure all aspects of the study startup process are met including activation timelines, facilitation and communication with internal and external stakeholders.
RESPONSIBILITIES:
The Start-Up Coordinator will work closely with the Start-Up Program Manager to support the maintenance of the inventory of status throughout the startup process until internal study activation is granted. This includes working with study teams to closely track and review timelines and key milestones during the start-up phase.
This role will support site start-up activities including but not limited to the review, collection and finalizing of Confidentiality Disclosure Agreements Clinical Trial Agreements, Material/Data Transfer Agreements and Disclosure Agreements. This includes corresponding with and providing site level information to sponsors including information about HCCR's feasibility process, SQV's, initial site documentation, budget negotiations, regulatory, and training, etc.
This role will interface works closely with sponsors and internal teams to provide the necessary documents/information to meet internal timelines, including studies identified as Rapid Activation trials.
This role will support HCCR leaders in identifying and mitigating obstacles for efficient and reduced study activation timelines.
Facilitates and efficient review and execution of clinical trial contracts/agreements.
Responsible for specific and assigned aspects of research infrastructure development and/or maintenance.
Communicates project status and improvement areas with leadership in a timely manner.
Supports the implementation of department-wide initiatives such as research process improvement efforts.
Participates in required training and education programs.
Participates in weekly research staff meetings.
Accommodates and adapts to change as environmental, organizational, workload, task, direction and other conditions change in a constructive and positive manner.
Manges conflict, disagreement and discord among and between staff and work units while recognizing and addressing sensitivities and stakeholder needs.
Demonstrates ability to work with a diverse group of people in a manner that enables them to reach their full potential, in pursuit of organizational objectives.
Fosters energy, enthusiasm, commitment, and an environment where people want to excel.
Demonstrates respect for diversity in people, ideas and backgrounds.
Maintains positive relationships with physician partners and practices mutual respects between hospital staff and our physician partners.
Provides feedback in a way that facilitates improvement and growth.
Takes time to mentor and support direct reports.
Anticipates future trends and consequences.
SKILLS:
The Clinical Research Department is seeking a detail-orientated clinical research leader with five or more years of clinical research experience.
At least four years of experience in clinical research regulatory processes.
Previous experience working with commercial IRBs.
In-depth understanding of current medical terminology specific to oncology.
Knowledge of patient electronic medical systems and CTMS or similar system.
Familiarity with FDA's Good Clinical Practice for clinical research.
Knowledge of all components of clinical trials/studies.
Ability to travel to multiple sites and attend off-site staff meetings, as needed.
Maintains knowledge of technology, tools, equipment and other devices in work area.
Demonstrates full knowledge and understanding of concepts and procedures needed to be successful in the role, including knowledge of applicable department, organization and external rules and regulations impacting day to day processes.
Effectively manages people, resources, deliverables, budgets, general administration and other components of day-to-day management of functional unit or department.
Ability to speak and write effectively, demonstrates fundamental command of language, communicates well using all mediums.
EDUCATION:
Bachelor's degree - required
Must have three to five years of clinical research experience
Must have completed 30-50 trails
Must be able to work flexible hours/overtime to meet deadlines and requirements
Must have previous experience with start-ups
Master's degree is preferred
Project Management Professional (PMP) - preferred
SOCRA or ACRP certification - preferred
Benefits: Medical, Dental, Vision, HSA, Employee Assistance Program (EAP), STD, LTD, Life and 401(K)
BAHAMA Consulting is an equal opportunity employer. If you need accommodation for any part of the application and hiring process or have any questions, please contact HR.
Clinical Research Coordinator - #233417
Clinical Research Associate Job 32 miles from Redondo Beach
This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization and Good Clinical Practices.
Responsibilities -
May be the sole coordinator or work in collaboration with a research nurse on studies, responsible for source documents, data collection, data entry, query resolution, triggering financial payments, study close out and liaison with the sponsor/CRO
Collects, verifies, organizes and records clinical information and data in electronic data capture systems EDC.
Abstracts data from necessary sources to complete the EDC and resolve queries.
Performs the following data related activities: EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding
Minimum Education and Experience Qualification Requirements:
Minimum 1 year experience with clinical trial coordination required
Minimum 1 year EDC data entry experience required
Experience with iMedidata platform highly preferred
Experience with Oncology (solid tumor) trials and data management highly preferred
Schedule/ Shift:
Part time, 16 hours a week
Weekly schedule will likely be Thursdays and Fridays (8 hours per day) but subject to change with onsite monitoring visit
Position is a contract, project based support role - current contract duration is estimated to be 6 months
Benefits (ONLY AVAILABLE FOR 30 hr/week + ASSIGNMENTS):
Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances)
Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).)
401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1)
Short Term Disability Insurance
Term Life Insurance Plan
Further Information:
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
Sr. Research Associate (In Vivo)
Clinical Research Associate Job 35 miles from Redondo Beach
OUR CLIENT:
Meet is proud to partner with a cutting-edge biotechnology in the Thousand Oaks area developing novel medicines targeting cardiovascular, neurodegenerative, and rare disorders.
We're searching for a highly motivated Sr. Research Associate (In Vivo) to be responsible for conducting pharmacology and pharmacokinetic studies in animal models of cardiometabolic and neurological disorders to evaluate therapeutic candidates through multiple readouts.
This will begin as a contract position and is expected to be long-term with option to convert FTE next year.
RESPONSIBILITIES:
Work closely with multidisciplinary scientific groups including discovery specialists and Biology team members
Conduct pharmacology and pharmacokinetic studies in animal models of cardiometabolic and neurological disorders to evaluate therapeutic candidates through multiple readouts
Contribute to design, planning and performance of in vivo studies related to mechanism of action, early exploratory indications, tolerability, PK/PD, and therapeutic efficacy
Hands-on in vivo skills to perform standard procedures including rodent handling, blood collection, dosing through multiple routes (IV, IP, SC, PO), urine collection, necropsies, and tissue collection in compliance with approved IACUC protocols and AAALAC regulations
Experience with stereotactic surgery of animal models of neurological disease is preferred
Prepare facilities and sterilize instruments for animal procedures
Maintain accurate records of experiments and procedures following approved company guidelines
REQUIREMENTS:
B.Sc or MS with minimum 3+ years of research experience
Strong in vivo background, performing standard procedures including rodent handling, blood collection, dosing
Excellent organizational and leadership skills, knowledge of lab equipment, procedures and day-to-day laboratory function, and strict follow-up of laboratory safety guidelines.
Familiarity with the basic lab software: Microsoft Office, GraphPad Prism, ELN for record keeping
Clinical Research Associate Manager
Clinical Research Associate Job 42 miles from Redondo Beach
At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.
We have built a team of driven professionals
with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn't just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.
This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.
Summary:
We are seeking a Clinical Research Associate (CRA) Manager to join our team at SpyGlass Pharma. The CRA Manager is responsible for leading and managing a team of field-based Clinical Research Associates who monitor clinical trials at investigative sites. This position ensures that clinical trials are conducted in compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and applicable standard operating procedures (SOPs). The CRA Manager will oversee the planning, execution, and management of site monitoring activities to ensure data integrity and patient safety.
Essential Duties & Responsibilities:
Manage, mentor, and provide leadership to a team of field-based CRAs, fostering professional development and high-performance standards.
Oversee site selection, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
Develop and implement monitoring plans and strategies to optimize site performance and data quality.
Collaborate with cross-functional teams, including Clinical Operations, Data Management, and Regulatory Affairs, to support clinical trial objectives.
Ensure that CRAs are adequately trained on study protocols, SOPs, and regulatory requirements.
Review monitoring reports and provide feedback to CRAs to ensure consistency and adherence to monitoring standards.
Identify and resolve site-related issues and escalate as appropriate to senior management.
Participate in the development and review of study documents, including protocols, case report forms, and informed consent forms.
Contribute to the development and improvement of departmental processes and SOPs.
Maintain up-to-date knowledge of GCP, FDA regulations, and industry best practices to ensure compliance.
Qualifications Required For Position:
Bachelor's degree in life sciences or a related field preferred.
10 years of clinical research experience in the pharmaceutical or medical device industry, with at least 2 years in a supervisory or managerial role overseeing field-based CRAs.
Strong knowledge of clinical trial monitoring practices, GCP, FDA regulations, and clinical trial management systems.
Proven ability to lead, mentor, and develop a team of clinical professionals.
Excellent verbal and written communication skills, with the ability to interact effectively with cross-functional teams and external partners.
Strong organizational and problem-solving skills with keen attention to detail.
Ability to travel up to 30-50% domestically as required.
Proficiency in Microsoft Office Suite and experience with electronic data capture (EDC) systems.
Why SpyGlass Pharma?
We are offering a range of $150,000 - $175,000, based on experience and qualifications, along with an Annual Bonus opportunity.
Share in our success with stock options, giving you a stake in the company's future.
Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
Generous paid time off, including holidays, vacation days, and personal leave.
SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to *********************** and let us know the nature of your request and your contact information.
LVN / Clinical Research Associate III, Vaccine Clinical Trials
Clinical Research Associate Job 13 miles from Redondo Beach
Manages day-to-day activities of a major segment(s) of medium to large studies or several smaller studies. May supervise project staff. Works under general supervision. Final review required for some phases of projects. Essential Responsibilities:
+ Manages day-to-day activities of a major segment(s) of medium to large studies or several smaller studies.
+ May assist in development of study tools (e.g. tracking forms, questionnaires, chart review forms, etc.).
+ Develops simple study protocols or portions of complex protocols.
+ Monitors progress of study activities (e.g. data collection and validation, recruitment, pilot studies, focus groups, etc.).
+ May coordinate research project activities with other research study centers.
+ Prepares progress reports independently and/or collaboratively.
+ May participate in the training of new team members and/or clinical staff.
+ If assigned to clinical trial, may work with Sponsors/ monitors at clinical sites.
+ Adheres to compliance and privacy/confidentiality requirements and standards.
+ Adheres to GCP and compliance regulations for clinical trials.
+ Assists with and/or oversees quality assurance of study activities; ensures quality data.
+ May assist with implementation of quality control measures.
+ Acquires and maintains knowledge of KP systems and databases.
+ Identifies, recommends and implements solutions to study issues.
+ Interfaces with IRB and drafts portions of IRB protocols, amendments, continuing reviews, etc.
+ Supervises and manages the day-to-day activities of project staff including evaluating performance.
+ May mentor and develop staff and participate in hiring.
+ Contributes to portions of study presentations.
+ Assists in writing scientific articles.
+ Serves as a member on department or study-related committees.
+ May recommend budget actions/decisions and manage project budget.
+ Reviews scientific literature and drafts portions of background section of grant proposals.
+ May contribute to other sections of grants.
Basic Qualifications:
Experience
+ Minimum four (4) years of experience in public health, healthcare administration, epidemiology, or healthcare-related field.
+ Minimum two (2) years of training and/or professional experience in research methodology/research study design, hypothesis testing; OR
+ Minimum two (2) years of experience in clinical protocols involving research methodology/research study design, and hypothesis testing.
+ Minimum two (2) years of training and/or experience managing research projects under general guidance.
Education
+ Bachelors degree in public health, healthcare administration, epidemiology, or health-related field (ex. Biology, Psychology, etc.), OR four (4) years of experience in a directly related field.
+ High School Diploma or General Education Development (GED) required.
License, Certification, Registration
+ N/A
Additional Requirements:
+ Experience creating flow charts, research instruments (e.g. chart review forms, questionnaires, etc.).
+ Experience in quantitative and/or qualitative data interpretation and application.
+ Must be able to prepare sections of professional reports and presentations.
+ Must be able to work in a Labor/Management Partnership environment.
Preferred Qualifications:
+ Minimum one (1) year of direct personnel management preferred.
+ Masters degree in public health, healthcare administration, epidemiology or related field.
+ Preferred Qualification - LVN (Licensed Vocational Nurse)
+ Vaccine / COVID 19 Clinical Trials experience
COMPANY: KAISER
TITLE: LVN / Clinical Research Associate III, Vaccine Clinical Trials
LOCATION: Los Angeles, California
REQNUMBER: 1300999
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.
Clinical Research Associate (Oncology CRA))
Clinical Research Associate Job 13 miles from Redondo Beach
Piper Companies is currently seeking a motivated Clinical Research Associate with Oncology Clinical Trials experience to work for a well-established clinical research organization and pharmaceutical company focused on improving the drug development process. Candidates for this opportunity must be located in California.
Responsibilities of the Clinical Research Associate:
* Develop and maintain relationships with investigative sites and client personnel
* Monitor sites for accuracy and validity of entries related to patient records and clinical notes
* Provide and communicate trial status and progress reports to trial manager and client
* Manage and maintain the data and documents required by local and ICH regulatory authorities
* Ensure SOPs are being followed and assist with client audits and regulatory inspections
Qualifications of the Clinical Research Associate:
* 2+ years of clinical monitoring experience required; CRO preferred
* 1+ years of experience within the therapeutic area of Oncology
* Experience with FDA, ICH GCP, and local regulations
* Strong communication, interpersonal and organization skills necessary
Compensation for the Senior Clinical Research Associate:
* Salary Range: $110,000-$120,000 based on experience
* Benefits: Competitive comprehensive benefits package included
Keywords: Clinical Research Associate, CRA, Oncology, Neuro, Infectious Disease, Vaccines, Rare Disease, Site Management, FDA, Regulatory, Regulatory Affairs, Clinical Operations, Clinical Research, Clinical Trials, CRO, Clinical Research Organization, Clinical Team, ICH, GCP, Contract, Biopharmaceutical, Biopharma, Pharmaceutical, Pharma, Medical Device, Therapeutics, Monitoring, Clinical, Management, Biological, Scientific, Patient Recruitment, Health, Dental, Vision, Retirement, Benefits, Remote, California, Los Angeles, CA, Sacramento, San Diego, San Francisco, San Jose
#LI-PB2 #LI-REMOTE
Clinical Research Associate - Cross TA - West/Southern California
Clinical Research Associate Job 13 miles from Redondo Beach
- Los Angeles, United States 2024-114959 - Clinical Monitoring - ICON Strategic Solutions - Remote **About the role** As a CRA you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. * Works on multiple trials within Cross TA/Immunology
* Quality of life focus wtih Regional Travel
* Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team
* Acts as Lead SM-training other SMs on study
* Develops site start up documents for studies including SIV agenda
* Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
* Represents LTMs or SMs on SMTs/meetings
* Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
* Supports country budget development and/or contract negotiation in liaison with CCS colleagues
* Assists with ASV
* Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other:
- Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
- Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
* Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
* Must be located in Southern California near a major airport
* Have 2-3 years' experience in monitoring pharmaceutical industry clinical trials
* Have a minimum of 1-3 years' experience monitoring s everal therapeutic areas
* Analytical/risk-based monitoring experience is an asset
* Ability to actively drive patient recruitment strategies at assigned sites
* Ability to partner closely with investigator and site staff to meet all of our study timelines
* Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
* Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
* Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
* Need to travel up to 50%
* To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs
* Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
* Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
*****************************************************
- Los Angeles, United States
2024-114959
- Clinical Monitoring
- ICON Strategic Solutions
- Remote
At ICON, our employees are our greatest strength . That's why we are committed to empowering you to live your best life , both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential.
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
Summary
Teaser label
Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.
Location
Belgium
Location
Belgium
Description
As a Clinical Research Associate (CRA) based in Belgium you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. For this role y
Location
United States
Location
United States
Description
As a Sr. CRA, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Location
Chicago, United States
Location
Chicago
United States
Description
As a CRA II you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Location
Chicago, United States
Location
Chicago
United States
Description
As a Clinical Research Asociate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Location
United States
Location
United States
Description
We are currently seeking a Lead Clinical Research Associate (Lead CRA) to join our diverse and dynamic team. As a Lead CRA at ICON, you will play a pivotal role in overseeing and managing clinical tri
Location
United States
Location
United States
Description
We are currently seeking a Lead Clinical Research Associate (Lead CRA) to join our diverse and dynamic team. As a Lead CRA at ICON, you will play a pivotal role in overseeing and managing clinical tri
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Clinical Research Associate I/CPT, Heart Institute - Los Angeles, CA
Clinical Research Associate Job 13 miles from Redondo Beach
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Job Description
Grow your career at Cedars-Sinai!
The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Join our team and use your experience with an organization known nationally for excellence in research!
The Clinical Research Associate I/CPT works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.
Primary Duties and Responsibilities
Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Completes Case Report Forms (CRFs)
Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines
Assists with clinical trial budgets and patient research billing
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law
May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Additional Qualifications/Responsibilities
Qualifications
Educational Requirements:
- High school diploma/GED required
- Bachelor's degree in Science, Sociology or related degree preferred
Licenses:
- Phlebotomy Certification required
Experience:
1 year clinical research experience preferred
Physical Demands:
- Able to perform moderate lifting.
- Able to sit, stand and walk for prolonged periods of time.
- Able to read papers and online documents.
- Able to operate standard office equipment.
- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Minimum Salary
19.50
Maximum Salary
32.86
Clinical Research Associate (Los Angeles, CA)
Clinical Research Associate Job 13 miles from Redondo Beach
Powered by **Clinical Research Associate (Los Angeles, CA)** **Summary:** The Clinical Research Associate (CRA) is responsible for managing and maintaining the Study Master File, tracking essential trial information, and supporting Regional Clinical Research Associates. Working under the guidance of a Clinical Manager or Director, the CRA ensures accurate documentation, regulatory compliance, and efficient coordination of trial logistics.
**Key Responsibilities:**
* Set up and maintain the Study Master File and Study Master File Tracker for each study.
* Receive, quality check, scan, and file study documents in the Study Master File; provide status updates to Clinical Management.
* Collect site start-up documents by directly communicating with site staff, preparing Regulatory Binders, and filing documents in the Study Master File.
* Track critical trial information, including team and site contact details, site status, enrollment, adverse events, and payments.
* Participate in clinical team meetings, assist with meeting logistics, and prepare materials and minutes as needed.
* Coordinate shipments of investigational products (IP) and other materials to trial sites.
**Qualifications:**
* Experience in ophthalmology and familiarity with clinical trial documentation.
* Strong data entry, problem-solving, and analytical skills.
* Proficiency in written and verbal communication, with presentation skills.
* Ability to work independently and collaboratively within a team.
* Excellent organizational skills and attention to detail.
* Knowledge of medical and ophthalmology terminology is helpful.
* Experience in study monitoring and auditing, with willingness to travel up to 75%.
Department: Direct Clients
This is a full time position
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Clinical Research Associate I (Per Diem) - Smidt Heart Institute
Clinical Research Associate Job 13 miles from Redondo Beach
The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Join our team and use your skills with an organization known nationally for excellence in research!
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties and Responsibilities
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.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Education
Highschool diploma/GED required
Bachelor's Degree in Science, Sociology or related degree preferred
Experience
1-year Clinical Research Related Experience
Clinical Research Associate II
Clinical Research Associate Job 2 miles from Redondo Beach
Minimum Qualifications: * Bachelor's degree life science-based degree * Previous work experience as a study coordinator working on a clinical trial * Bilingual in Spanish * Three years job-related experience * GCP, HIPAA, Conflict of Interest training (CITI coursework available, if needed).
* Excellent written, verbal, and interpersonal communication skills
* Attention to detail
* MS Office suite
* 3+ years of professional experience in a clinical research environment required
* Authorization to work in the US with no future restrictions.
* Although rare, project-specific work may take place on a weekend
* Assess study participants for adverse reactions or complications and manage side effects of study relate drugs.
* Establish and maintain a strong partnership with the subject to achieve study objectives.
* Direct acquisition and analysis of laboratory research data following GCP and FDA regulations
* Prepare and maintain IRB and regulatory documentation for various this projects and consent patients for clinical research.
* Facilitate constant communication between principal investigators, Co-Is, facilitators and CTRC staff, and patients to address concerns and maximize eligibility and enrollment.
* Maintain audits, collecting/organizing/communicating observations, and creating written outines for weekly executive meetings.
* Assist in preparation of investigator-initiated protocols, IRB submissions, and assist in research budgeting contracts.
* Perform routine monitoring activities ensuring quality control at study visits along with proper documentation and GCP.
Responsibilities:
* Interpret, adhere to, and enforce detailed research protocols and regulatory requirements from Screening to Study Close-out. Maintain the Investigator Binder and Subject Binder in a complete and orderly manner, available for audits at any time.
* Schedule subjects for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patients based on standing protocol orders. Coordinate appointments for subjects with their assigned specific facilitator. Complete CRFs and forms for subject-related costs reimbursement.
* Adhere to documentation procedures to ensure cGMP and GCP. Implement GCP and HIPAA compliance for all study-related activities.
* Communicate effectively with team members, research manager, and physicians via oral, written, and teleconferencing for study-related and ancillary activities. Present research findings to the supervisor through verbal and written communications.
* Maintain confidentiality of patient-relate records (HIPAA) including written and verbal communications.
Salary: $32-$38
Clinical Research Associate II
Clinical Research Associate Job 2 miles from Redondo Beach
**Clinical Research Associate II** Department **Psychiatry-1751** Location **The Lundquist Institute - Torrance, CA** **Minimum Qualifications:** * Bachelor's degree life science-based degree * Previous work experience as a study coordinator working on a clinical trial
* Bilingual in Spanish
* Three years job-related experience
* GCP, HIPAA, Conflict of Interest training (CITI coursework available, if needed).
* Excellent written, verbal, and interpersonal communication skills
* Attention to detail
* MS Office suite
* 3+ years of professional experience in a clinical research environment required
* Authorization to work in the US with no future restrictions.
* Although rare, project-specific work may take place on a weekend
* Assess study participants for adverse reactions or complications and manage side effects of study relate drugs.
* Establish and maintain a strong partnership with the subject to achieve study objectives.
* Direct acquisition and analysis of laboratory research data following GCP and FDA regulations
* Prepare and maintain IRB and regulatory documentation for various this projects and consent patients for clinical research.
* Facilitate constant communication between principal investigators, Co-Is, facilitators and CTRC staff, and patients to address concerns and maximize eligibility and enrollment.
* Maintain audits, collecting/organizing/communicating observations, and creating written outines for weekly executive meetings.
* Assist in preparation of investigator-initiated protocols, IRB submissions, and assist in research budgeting contracts.
* Perform routine monitoring activities ensuring quality control at study visits along with proper documentation and GCP.
**Responsibilities:**
* Interpret, adhere to, and enforce detailed research protocols and regulatory requirements from Screening to Study Close-out. Maintain the Investigator Binder and Subject Binder in a complete and orderly manner, available for audits at any time.
* Schedule subjects for study procedures; initiate/coordinate drug orders, laboratory procedures and treatments for patients based on standing protocol orders. Coordinate appointments for subjects with their assigned specific facilitator. Complete CRFs and forms for subject-related costs reimbursement.
* Adhere to documentation procedures to ensure cGMP and GCP. Implement GCP and HIPAA compliance for all study-related activities.
* Communicate effectively with team members, research manager, and physicians via oral, written, and teleconferencing for study-related and ancillary activities. Present research findings to the supervisor through verbal and written communications.
* Maintain confidentiality of patient-relate records (HIPAA) including written and verbal communications.
Salary: $32-$38
Clinical Research Associate I - Department of Medicine
Clinical Research Associate Job 34 miles from Redondo Beach
**City of Hope** **Duarte** **Clinical Research Associate I - Department of Medicine** 2024-05-09 Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
City of Hope is seeking a Clinical Research Associate I to manage an assigned set of clinical research studies and protocols to assure efficiency and regulatory compliance. Under PI and supervisor guidance, responsible for collection, registration, and submission of data. Maintains a system for effective sample collection, movement, and storage, as well as data flow associated with research protocols.
**As a successful candidate, you will:**
* Conduct protocol management for assigned clinical studies, ensuring adherence to protocols and regulations.
* Maintain accurate protocol documentation and promptly notify PI/supervisor of relevant protocol changes or data management issues.
* Complete and manage regulatory documents for IRB, DSMB, and PRMC/CPRMC, submitting data as per protocol requirements.
* Play an active role in patient recruitment, establishing and maintaining interpersonal relationships while ensuring confidentiality.
* Collect and deliver specimens for analysis, ensuring proper labeling and adherence to safety practices and shipping instructions.
* Engage in data abstraction and analysis, liaising with institutional resources like Posiedon and Honest Broker, and providing project management for computational projects. Assist in result write-ups and address any roadblocks.
**Your qualifications should include:**
* Associate's Degree; experience may substitute for minimum education requirements
* One-year experience working in a health care setting, preferably in research
**City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity and inclusion, please**
**click here**
Research Associate II, Infectious Disease Clinical Trials
Clinical Research Associate Job 13 miles from Redondo Beach
**Research & Development** **Discover Tomorrow's Care** You and your team will play a critical role running more than 2,500 studies and clinical trials that could profoundly impact the future of health. **Research Associate II, Clinical Trials** **Primary Location** Los Angeles, California **Worker Location** Flexible **Facility** 4900 Sunset Medical Offices **Job Number** 1290181 **Date posted** 09/10/2024 **Navigating the Hiring Process**
We're here to support you!
Please visit the page on our website for assistance.
Please visit the page for assistance or reach out to the web manager at ***************.
A reasonable accommodation is any modification or adjustment that enables you to fully participate in completing the following:
* Online Submissions
* Pre-Hire Assessments
* Interview Process
Please submit your and an HR Representative will contact you.
**Description:** **Job Summary:**
Coordinates day-to-day activities of several small scale project(s) or phases of one or more larger projects. May oversee assigned work of project staff. Works under general supervision. Final review required for each phase of project.
**Essential Responsibilities:**
* Coordinates day-to-day activities of several small scale project(s) or phases of one or more larger projects. Collects project data through interviews, chart review or other methods. May collect, secure and assist with biospecimen management.
* May assist in development of study tools (e.g. tracking forms, questionnaires, chart review forms, etc.).
* Assists with and/ or oversees assigned study activities (e.g. data collection and validation, recruitment activities, pilot studies, focus groups, etc).
* Drafts project progress reports collaboratively.
* May participate in the training of new team members and/or clinical staff. If assigned to clinical trial, may work with Sponsors/ monitors at clinical sites.
* Adheres to compliance and privacy/ confidentiality requirements and standards. Adheres to GCP and compliance regulations for clinical trials.
* Assists with and/ or oversees quality assurance of study activities; ensures quality data.
* Acquires and maintains knowledge of KP systems and databases.
* Identifies, recommends and implements solutions to study issues.
* May interface with IRB and/ or draft portions of IRB protocols, amendments, continuing reviews, etc.
* May supervise the day-to-day activities of project staff (ex. assign work and evaluate performance, etc).
* May assist with staff hiring and training.
* May contribute to portions of study presentations.
* Serves as a member on department or study-related committees.
* May track expenses and monitor budget. May recommend budget actions/ decisions.
* May provide information and oversight for invoices.
* Reviews scientific literature and synthesizes and summarizes information.
**Basic Qualifications:**
Experience
* Minimum two (2) years of experience in public health, healthcare administration, epidemiology, or healthcare-related field OR one (1) year of experience in public health, healthcare administration, epidemiology, or healthcare-related field AND Masters or terminal degree in public health, healthcare administration, epidemiology, or healthcare-related field
* Minimum one (1) year of experience coordinating research projects under specific guidance.
* Minimum one (1) year of training and/or experience in research methodology/research study design, hypothesis testing; OR
* Minimum one (1) year of experience in clinical trials protocols involving research methodology/research study design, and hypothesis testing; OR
* Minimum one (1) year experience in handling, processing, and preparing biospecimens for laboratory analysis and/or transport OR Masters or terminal degree in public health, healthcare administration, epidemiology, or healthcare-related field.
Education
* Bachelors degree in public health, healthcare administration, epidemiology, or health-related field (ex. Biology, Psychology, etc.), OR four (4) years of experience in a directly related field.
* High School Diploma or General Education Development (GED) required.
License, Certification, Registration
* N/A
**Additional Requirements:**
* Experience with interviewing (by phone and/or in-person) and medical chart review.
* Experience in quantitative and/or qualitative data interpretation.
* Experience coordinating one or more projects OR
* Experience with biospecimen handling, collection, and processing
* Experience with Clinical lab activities
* Professional oral and written communication skills.
* Must be able to work in a Labor/Management Partnership environment.
**Preferred Qualifications:**
* Experience with Infectious Diseases or related areas of research
* Bilingual Spanish
* Masters degree in public health, healthcare administration, epidemiology or related field.
**Primary Location:** California,Los Angeles,4900 Sunset Medical Offices **Scheduled Weekly Hours:** 40 **Shift:** Day **Workdays:** Mon, Tue, Wed, Thu, Fri **Working Hours Start:** 08:00 AM **Working Hours End:** 04:30 PM **Job Schedule:** Full-time **Job Type:** Standard **Worker Location:** Flexible **Employee Status:** Regular **Employee Group/Union Affiliation:** NUE-SCAL-01|NUE|Non Union Employee **Job Level:** Individual Contributor **Department:** Department of Research and Evaluation **Pay Range:** $65100 - $84150 / year Kaiser Permanente strives to offer a market competitive total rewards package and is committed to pay equity and transparency. The posted pay range is based on possible base salaries for the role and does not reflect the full value of our total rewards package. Actual base pay determined at offer will be based on labor market data and a candidate's years of relevant work experience, education, certifications, skills, and geographic location. **Travel:** No **Flexible:** Work location is on-site at a KP location, with the flexibility to work from home. Worker location must align with Kaiser Permanente's Authorized States policy. At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do. We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work. Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.
Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status.
For jobs where work will be performed in unincorporated LA County, the employer provides the following statement in accordance with the Los Angeles County Fair Chance Ordinance. Criminal history may have a direct, adverse, and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment:
- Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente's Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting non-compliance, and adhering to applicable federal, state, and local laws and regulations, accreditation, and licensure requirements (where applicable), and Kaiser Permanente's policies and proced
Clinical Research Associate I
Clinical Research Associate Job 34 miles from Redondo Beach
Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
City of Hope is seeking a detail-oriented Clinical Research Associate I to manage multiple research protocols and projects, ensuring efficiency and regulatory compliance. This role involves attending clinic sessions as needed, with mentorship from experienced staff. Responsibilities include compiling, registering, and submitting data, maintaining effective data flow systems, and coordinating meetings and the transportation of research samples. Join our team to contribute to impactful research while developing your skills in a supportive environment.
As a successful candidate, you will be:
* Manages multiple research protocols, ensuring accurate documentation, regulatory compliance, and protocol updates.
* Coordinates specimen collection, processing, labeling, and shipment, ensuring safety and accuracy in handling.
* Collaborates with physicians/nurses to ensure protocol-related tests and evaluations are completed and supports patient recruitment.
* Identifies and communicates protocol or data management issues to supervisors and participates in special projects.
* Promotes professional development, maintains an organized work environment, and provides staff support as needed.
Your qualifications should include:
* Associate's degree required; Bachelor's degree in Biological Sciences or a related field strongly preferred.
* At least one year of experience in a healthcare setting, with a preference for clinical research experience.
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.
To learn more about our Comprehensive Benefits, please CLICK HERE.