Clinical Research Coordinator II (Hybrid)
Clinical Research Coordinator Job 27 miles from West Covina
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries.
Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities
Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
Schedules patients for research visits and procedures. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
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. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
Notifies direct supervisor about concerns regarding data quality and study conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
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 coordinate training and education of other personnel.
May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
May identify new research opportunities and present to investigators
Participates in required training and education programs.
Qualifications
This role follows a hybrid work schedule; however, we can only consider applicants who will be able to commute to our Los Angeles work location a few times per week. If hired you must reside in the commutable area.
Requirements:
High School Diploma/GED required. Bachelor's Degree Science, Sociology or related degree preferred.
2 years Clinical research related experience required.
#Jobs-Indeed
Req ID : 5685
Working Title : Clinical Research Coordinator II (Hybrid)
Department : Cancer - SOCCI Clinical Research
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : EXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $28.30 - $48.11
Onsite Study Tweedy
Clinical Research Coordinator Job 27 miles from West Covina
Task description TELUS Digital is seeking participants for a study in Los Angeles, CA. During your onsite session, you will be video recorded performing easy tasks, such as sitting, standing, or moving around in an office environment. The tasks are guided by a study moderator and can be easily completed—no prior
experience or special skills needed.
Study Details
● Earn $100 for completing an onsite session (after signing in, the session could take more than an
hour).
● Earn a$20 bonus for arriving at least 15 minutes before your scheduled start time.
● Must be able to read, speak, and understand instructions provided in English.
● Must be 20–65 years of age.
● Must be a U.S. citizen, legal permanent resident, or authorized to work in the U.S. for payments
to be processed (proof will be required).
You can also refer others who might be interested in participating. Once your referral successfully
completes the project, you’ll receive a $20 reward. It’s that simple!
Hurry—your referrals must complete the study by April 30, 2025 only!
Referrals must reside in Los Angeles, CA or nearby areas to attend the study in person. To qualify for the
bonus, your referrals must list your name and email under “I was referred by someone” on the
registration form.
Payments are exclusively issued via Hyperwallet. Hyperwallet’s payout methods are limited to PayPal,
bank transfer, or Venmo.
Interested? Please register here:
***********************************************************************************************
A/66296
For questions, please contact ********************************; we will gladly assist you.
"All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, national origin, disability or protected veteran status."
Additional information:
Employment type: Full-time
Senior Clinical Research Specialist
Clinical Research Coordinator Job 29 miles from West Covina
Join Kelly FSP as Senior Clinical Research Specialist with our Medical Device client in Irvine, CA!
If you're a clinical research professional with 5+ years of monitoring experience this is a fantastic opportunity!
5+ years of co-monitoring/monitoring experience
Medical Device experience
Travel up to 20% nationwide
This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations, procedures and guidelines, this position:
Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones.
Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
May serve as the primary contact for clinical trial sites (e.g. site management);
Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….), ensure registration on ********************** from study initiation through posting of results and support publications as needed;
Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel;
Oversee the development and execution of Investigator agreements and trial payments;
Responsible for clinical data review to prepare data for statistical analyses and publications;
If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;
Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
Support project/study budget activities as assigned;
Develop a strong understanding of the pipeline, product portfolio and business needs;
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
Perform other duties assigned as needed;
Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations.
EXPERIENCE AND EDUCATION
Education
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Experience
BS with at least 5 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.
Previous experience in clinical research or equivalent is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
Clinical/medical background a plus.
Medical device experience highly preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Functional and Technical Competencies:
Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
Proven track record in supporting delivery of clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
Good presentation and technical writing skills;
Good written and oral communication skills;
Leadership Competencies:
Ability to lead small study teams to deliver critical milestones, as may be assigned.
Leadership required in alignment with Leadership Imperatives:
Connect - Develop collaborative relationships with key internal and external stakeholders.
Shape - Make recommendations for and actively participate in departmental process improvement activities.
Lead - Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.
Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.
Clinical Research Manager - 240753
Clinical Research Coordinator Job 27 miles from West Covina
As the experienced Clinical Research Coordinator, you will work with a team that is dedicated to bringing quality care to those in the community who need it most. The majority of our patients are Hispanic, speak Spanish, and are diabetic. We work mostly in the diabetic wound care space, where we help patients find access to new treatments and devices so they can avoid amputations. The patients we support and provide care to are from underserved and minority populations that typically don't get the focus they deserve. We are on a mission to fix that.
We work on both federally and privately funded studies.
As a member of the team, you will::
Collaborate with our team of clinical research coordinators
Work closely with renowned doctors and researchers
Work with our doctors across multiple clinics to recruit, screen, and enroll patients
Review and comprehend study protocols
Coordinate and attend monitor site visits and prepare site visit documentation
Ensure study staff is properly trained on trial protocols
Oversee patient scheduling and follow-up activities
Facilitate and coordinate the daily clinical trial activities
Manage and maintain documentation for each trail
Collect protocol data and enter information into the electronic data capture (EDC) system
Act as a reviewer to ensure the trial protocols are being followed accurately
Works with monitors to ensure protocol guidelines and deadlines are being met
Experience we are looking for:
5+ years as a Clinical Research Coordinator (CRC)
Experience in wound care and diabetes (not required)
Fluent in English and Spanish
Phlebotomy certificate or Medical Assistant
Experience in patient-facing roles
Experience in IRB submissions, source documentation, and trial management
A thorough understanding of regulatory requirements and principles of GCP
Hours: Monday-Friday, 8am-5pm
Pay: $80,000 - $83,200
Clinical Research Coordinator
Clinical Research Coordinator Job 27 miles from West Covina
CARE Institute is a start-up company firmly established in the research industry. We provide quality clinical research that significantly impacts the health of patients and communities. Our mission is to advance scientific and medical knowledge within the industry.
The clinical research coordinator (CRC) is responsible for all aspects of the clinical trial, ensuring trouble-free running of all clinical trials. This is not limited to one trial at a time. The CRC will be monitoring the study to ensure that it complies with protocols, is ethically conducted and follows regulatory standards. The CRC will work with the Recruitment Specialist and Regulatory Specialist in completing all forms, procedures, and compliance for each trial. Attention to detail and organizational skills are essential for success in this role.
Responsibilities:
Supervise the daily activities of a study and monitor the activities of the subjects and researchers
Perform various medical procedures including patient vitals, phlebotomy, run labs, EKG, etc.
Interact professionally with trial compliance monitors, answer all queries and make necessary corrections
Dispense medication upon provider approval, provide drug accountability, and chart all actions
Maintain research records of study activity, including case report forms, drug dispensation records and other regulatory forms as per FDA guidelines
Ensure equipment and supplies needed for the study are in stock and in good working order
Run all Source system document generations for each trial
Provide patient education on all trial details
Direct the collection, labeling, storage and transport of all specimens
Review and comprehend the protocol
Use Clinical Trial Management System (CTMS) to manage subject visits, documentation, and study tracking at the site level
Minimum Qualifications:
Fluency in Spanish and English required
GCP and Human Subjects Protection Certification required
3-5 years of Clinical Research experience required
Ability to work independently and in a team environment
Excellent communication and problem-solving skills
Attention to detail and organizational skills
Proficiency in performing EKGs, blood collection, obtaining vitals and documenting medical history
Good Clinical Practice (GCP)
Proficiency in Microsoft Office and Google Docs
Knowledge of medical terminology
Knowledge of ICH/GCP and regulatory requirements
Proficiency with Electronic Data Capture (EDC) Systems
Proficiency with Clinical Trial Management Systems (CTMS) - experience with Clinical Research IO (CRIO) preferred
Experience with nephrology preferred but not required
Work Environment:
This position works under normal office conditions and in a laboratory/clinic environment. The employee may be exposed to infectious diseases, blood, and bodily fluids.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
The employee must have the ability to lift, pull, push, and manipulate equipment and patients, which requires strength and gross motor and fine motor coordination. The employee must be able to administer prescribed treatments. The position requires sitting and/or standing for long periods of time. The position requires the ability to operate a computer.
CARE is an Equal Opportunity Employer. CARE does not discriminate based on race, religion, color, gender, or sexual orientation.
Clinical Practice Research & Policy Coordinator, Education, Full time, Days
Clinical Research Coordinator Job 8 miles from West Covina
The Clinical Practice Research and Policy Coordinator is responsible for the oversight and coordination of the development, implementation, evaluation, and maintenance of clinical policies, evidence-based practices, nursing research activities within PIH Health Hospitals. This role involves ensuring clinical practice and policies are in compliance with healthcare regulations and consistent with professionally recognized standards of practice. As an integral part of the interdisciplinary team, the Clinical Practice Research and Policy Coordinator enhances patient care through data-driven policy development; clinical research and evidence-based projects. The coordinator collaborates with clinical staff, Quality Management, Regulatory Affairs, and the Education department to improve standards of care and promote best practices in patient care across the enterprise.
PIH Health is a nonprofit, regional healthcare network that serves approximately 3 million residents in the Los Angeles County, Orange County and San Gabriel Valley region. The fully integrated network is comprised of PIH Health Downey Hospital, PIH Health Good Samaritan Hospital, PIH Health Whittier Hospital, 37 outpatient medical office buildings, a multispecialty medical (physician) group, home healthcare services and hospice care, as well as heart, cancer, digestive health, orthopedics, womens health, urgent care and emergency services. The organization is nationally recognized for excellence in patient care and patient experience, and the College of Healthcare Information Management Executives (CHIME) has identified PIH Health as one of the nations top hospital systems for best practices, cutting-edge advancements, quality of care and healthcare technology. For more information, visit PIHHealth.orgor follow us on Facebook,Twitter, or Instagram.
Required Skills
Excellent written and verbal communications, interpersonal skills.
Highly developed skills in written and verbal communications to convey complex clinical, technical, and education and training information, and to produce high-quality reports, documentation, and presentations.
Highly developed interpersonal and diplomatic skills to advise and guide teams and influence all levels of management and staff and to develop strong working relationships with nursing staff and leadership. Proficiency in research methodologies and policy writing.
Demonstrated knowledge of relevant regulatory requirements, as well as related legislative, accreditation, licensing, and compliance environments.
Skills and expertise in project management, with demonstrated ability to initiate projects and lead teams, prioritize tasks, and direct projects successfully from inception to completion on task and on schedule. Intermediate to advanced computer skills
Required Experience
Required:
Active Registered Nurse (RN) license
Minimum of 5 years of clinical nursing experience
DNP or PhD in Nursing or MSN with PhD in another field
Current Basic Life Support Card
Preferred:
Experience with policy writing, healthcare legislation, and hospital compliance requirements
Experience in nursing research
Knowledge of methodology for data collection, analysis, and reporting.
Address
12401 Washington Blvd.
Salary
54.32-89.63
Shift
Days
FLSA Status
Professional-Exempt
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Clinical Project Manager
Clinical Research Coordinator Job 32 miles from West Covina
Our client, a Fortune 500 medical device company, has engaged GForce Life Sciences to provide a Clinical Project Manager who will report directly to the Senior Manager, Project Management. The Clinical Project Manager will provide project management expertise throughout the development and implementation of clinical studies. Interacts with various study support groups and the business unit in order to assist in clinical strategy, the development of study plans, and project deliverables.
Job Duties
Facilitates communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to mgmt staff.
Facilitates site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members.
Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
Identify resource needs and elevates/resolves resource constraints with mgmt.
Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
Facilitates the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction.
Provides input to protocol design, case report form design, data management plan, monitoring plan.
Organizes Steering Committee meetings and communication; Coordinates investigator and research coordinator meetings.
Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations
Works with Study Team to coordinate activities for all milestones; database locks, annual reports, presentation and publications
Sets quality and compliance goals for the trial and monitors/manages compliance as part of clinical project management.
Develops additional project management tools to improve clinical trial performance.
Requirements
Bachelor's degree in Health Sciences field preferred
Minimum of 2 years clinical project management experience
Minimum of 5 years in clinical trials
IDE experience
Medical device experience
Cardiovascular device experience preferred
Contract Details:
Location: Onsite, 5 days/week in Plano, TX | Sylmar, CA | Santa Clara, CA | Maple Grove, MN
Type: Contract (12+ months)
R&D Project Coordinator
Clinical Research Coordinator Job 29 miles from West Covina
On-Site Role
Kelly Services is proud to collaborate with a renowned leader in the medical device industry. We are seeking a driven and detail-oriented R&D Project Coordinator to join an innovative team based in Irvine, CA.
This position offers a unique opportunity to actively contribute to the development and lifecycle of advanced medical technologies while engaging with cross-functional teams in a dynamic and professional environment.
Who We're Looking For:
We understand that candidates may not meet every single requirement listed. We are seeking applicants who possess a strong foundational understanding of the role and demonstrate a willingness to learn and grow. If you have a can-do attitude, a commitment to excellence, and a passion for problem-solving, we encourage you to apply. Training will be provided in areas where skills may need development.
Position Title: R&D Project Coordinator
Employment Type: Full-Time
Hourly Compensation: $40
Benefits: Comprehensive Benefit Package
Location: Irvine, CA
Key Responsibilities:
Coordinate new product development activities, including material sourcing, supply chain management, and design control for development builds.
Maintain inventory control and oversee Device History Files for product submissions.
Manage project budgets, track expenses, and reconcile purchase orders in alignment with financial goals.
Facilitate contracts and logistics for healthcare professionals (HCPs) and research engagements.
Support compliance activities and contribute to cost improvement, business continuity, and process excellence initiatives.
Lead communication of R&D updates and perform program management duties as needed.
Qualifications:
Bachelor's degree in a relevant field with 4-6 years of experience (or an Associate's degree with 6+ years of experience).
Proficiency in MS Office and enterprise systems (e.g., PLM systems, Totality, JDE, ARIBA, Windchill).
Strong multitasking abilities, excellent communication skills, and attention to detail.
Experience in medical devices or product development processes is preferred but not required.
Knowledge of financial accounting, supply chain, and specialized areas such as BOMs, routings, and product structure is a plus.
Join a team dedicated to advancing healthcare through innovative solutions. You'll have the opportunity to work on impactful projects in a collaborative environment that values professional growth, creativity, and teamwork.
Please submit an up-to-date resume for immediate consideration.
Thank You
Kelly Services
Research Coordinator: Big Law Partner Recruiting Agency
Clinical Research Coordinator Job 27 miles from West Covina
Prestigious Agency focuses on law firm partner level recruiting seeks an outstanding candidate to head up the Research Coordinator division.
Our clients are predominantly Top 20 Global law firms, and the best individual partners and groups who work at these firms. Our markets are all over the world including major US markets, London, Asia, the Middle East and key European cities.
You will work with the Research & Marketing team to identify and curate comprehensive lists of potential lawyer partners, practice groups, and legal professionals for specific client needs. You will maintain and update our extensive database with accurate and relevant information and ensure data integrity and consistency for effective outreach each day. Target lists will be compiled based on our clients' hiring needs. In addition, you will conduct in-depth market research to identify trends, emerging law firms, and potential growth areas and provide insights to the team for strategic decision-making.
This is a fast-paced role that requires constant attention, close attention to trends, and a high degree of meticulousness. In the end, we are looking for someone who always wants to better their work and hold themselves to a standard that matches our law firm clients' needs.
We are a leading agency worldwide and known for our prolific email marketing campaigns at the highest levels of the BIGLAW community. You will learn more about law and business more than most any job. Earning potential is limitless.
*You will also collaborate closely with the CEO, especially when she receives specific partner requests from the firms we work with.
Ideal Candidate:
1) Positive, strategic, and detail-oriented
2) Quick learner with the ability to adapt
3) Extremely persistent and focused
Recent college graduates with an interest in law are encouraged to apply.
Requirements:
Bachelor's degree from a reputable 4-year college
Typing Speed 65+ WPM
Highly accurate spelling and grammar.
Meticulous about accuracy, incredibly organized, and likes structure.
Proficient in computer usage and database management.
Openness to constructive feedback and a drive to improve one's work.
Demonstrates a strong work ethic, including reliable attendance, and is collaborative in a team environment.
A TEAM leader!
Compensation & Benefits:
Hourly Pay - $26-28/hr
*Please note overtime is regularly available (time & a half) and, on occasion, required.
Job Type: Full-time, Weekends as needed
Schedule: Monday to Friday, 9 AM - 5:30 PM
Location: In Person at the Westwood Office in Los Angeles, CA 90067- must be able to reliably commute or planning to relocate before starting work.
Benefits:
Health insurance
401K
Clinical Operations Specialist
Clinical Research Coordinator Job 29 miles from West Covina
Duration: 12+ Months Contract (Part-Time job, 20 hours per week)
Part-time work schedule: PT work schedule to 4 days on-site/week (8 AM-12 PM) with the flexibility to WFH on Fridays OR candidates can choose to work 2.5 full days each week (e.g. Mon, Weds + Thurs only) instead of splitting the 20 hours across 5 days if that is their preference.
More on this position:
Does your team use any specific technology/software you want us to look out for? JDE, SharePoint, MS Office Suite, EDC, TMF, CTMS
What will a typical workday look like? Clinical study device management activities such as ordering devices, coordinating international and domestic shipments, facilitating the return of study devices and equipment, managing clinical study and research laboratory device inventory, and completing associated clinical study documentation as needed. This is a collaborative role, which requires solid communication skills and very good attention to detail.
Top 3 required technical skills? Must-haves? Preferred technical skills: Clinical research coordination, clinical study management, study document (e.g., ICF) and CRF (case report form) review
Nice-to-have skills? EDC, CTMS, Veeva (TMF), GCP training, experience with medical device studies
Education and Experience:
Bachelor's Degree
0-2 years of experience
If a candidate does not have a Bachelor's degree but has either an Associate's degree and 4 years of relevant experience or a High School diploma and 7 years of relevant experience, then they would meet the qualifications of the role.
Clinical Research Project Manager
Clinical Research Coordinator Job 27 miles from West Covina
Title: Clinical Research Project Manager
Required Knowledge and Experience:
Experience working within or closely with a Healthcare IT Project Management Office
Strong technical project management capabilities
Proven ability to build business cases, project justifications, and ROI (return on investment) reports
Exceptional attention to detail
Excellent written and verbal communication skills; ability to convey complex information professionally and clearly
Hands-on experience with electronic data capture systems, including electronic medical record (EMR) systems
Bachelor's degree in a related field and at least five years of experience managing health informatics projects
Solid understanding of research regulatory requirements, formal project management methodologies, and business requirements gathering and analysis
Preferred Qualifications:
Understanding of clinical trials research processes
Experience managing research budgets
Background in clinical data research projects or work in an academic medical environment
Familiarity with HL7 Clinical Document Architecture (CDA) and/or FHIR standards
Key Responsibilities:
Support strategic planning and tactical execution of clinical research data projects, including analysis and implementation
Facilitate communication among project stakeholders, including clinical researchers and data scientists
Provide project oversight, direction, and coordination for research data initiatives
Lead project planning, execution, reporting, and closeout activities to align with approved strategies and deliverables
Manage and coordinate project management functions for cross-functional teams in a matrixed environment
Ensure compliance with policies and procedures related to project management, procurement, contracts, and fiscal planning
Assist in the development of various program reports, including monthly, quarterly, and annual summaries
Coordinate meeting logistics including agendas, notes, minutes, and action item tracking for committees, advisory panels, scrum teams, and other stakeholder groups
Draft and review business and scientific documents to support operational needs
Maintain consistent and clear communication regarding project status with all internal and external stakeholders
Special Knowledge, Skills & Abilities:
Demonstrated success leading multiple projects simultaneously, with the ability to adapt to evolving business needs
Skilled in working with diverse stakeholder groups including principal investigators, faculty, academic leadership, and administrative staff
Experience managing interdisciplinary teams with varied technical, clinical, and analytical expertise
Leadership experience in cross-platform research data acquisition and management initiatives
Highly detail-oriented and organized
Proficient in project management and productivity tools such as MS Project, Excel, Word, Teams, and Visio
Familiar with cloud-based data environments including research-specific security and privacy standards (e.g., IRB, HIPAA)
Knowledge of compliance and information security requirements
In-depth understanding of EMR, research, and public health workflows, particularly as they relate to data creation and exchange
Familiarity with the organization, storage, cataloging, and analysis of healthcare data
Understanding of research data management tools and standards used for data ingestion and curation
Preferred Technical Skills (Bonus):
Knowledge of medical coding systems such as ICD, CPT, LOINC, and MedDRA
Familiarity with OMOP, OHDSI tools, and REDCap
Experience with Cerner EMR systems
Exposure to Amazon Web Services (AWS) and their healthcare-related offerings
Clinical Research Associate Manager
Clinical Research Coordinator Job 37 miles from West Covina
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, healthcare, or a related field; advanced degree 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. (A commensurate combination of education and experience will be considered.)
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.
Sr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute
Clinical Research Coordinator Job 11 miles from West Covina
Company DescriptionJobs for Humanity is partnering with CEDARS-SINAI to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located.
Company Name: CEDARS-SINAI
Job Description
Grow your career at Cedars-Sinai!
The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all of our patients with cancer!
Join our team and contribute to groundbreaking research!
Job Summary:
This position functions as a Sr. Clinical Research Finance Coordinator, responsible for coordinating and executing the financial billing of clinical trials, formation of the Medicare Coverage Analysis grid, and the development of clinical trial budgets. He/She is responsible for the calculation of statistical, fiscal, and metric data as it relates to clinical trial activities. The Sr. CRFC also assures the building of budgets/contract agreements within the Clinical Trial Management System (CTMS). This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical
professionals, pharmaceutical staff, and Sponsor representatives to successfully oversee the research billing aspects of the
Medical Care Foundation.
Primary Duties and Responsibilities
• Develops and updates Medicare Coverage Analysis grids in order to assess which procedures/services within the protocol
are covered under Medicare guidelines. Works in conjunction with Cedars-Sinai Industry Sponsored Research Office in
order to produce a final document.
• Routinely monitors and reconciles trial accounts to ensure timely deposit, correct allocation, and distribution of revenue.
• Provides financial related data as needed, to internal team members and/or manager/director.
• Work with Accounts Payable to process and monitor that timely payments are made to various internal groups, external
partners, patients, and/or joint sites according to contractual/budgetary agreement.
• Responsible for accurate and timely fiscal data collection, documentation, entry and reporting into CTMS, including timely
response to sponsor communication.
• Develop and maintain statistical and fiscal reports as they relate to clinical trial activity on a monthly and fiscal year
basis.
• Process timely invoices which follow protocol driven procedures according to patient accruals/visits in order to seek
reimbursement from industry sponsors.
• Oversees and monitors billing work queue within the Electronic Medical Records system (EPIC) and adjudicates patient
bills according to final contract/budget.
• Critically evaluates research protocols to assess resource needs; assessment includes all research procedures, clinical
research staff time, investigator time, and costs from ancillary departments.
• Develops clinical trial budgets and negotiates with industry sponsors. Renegotiates budgets as part of trial maintenance
through amendments.
• Creates and finalizes payment terms (contract language) in conjunction with industry sponsor.
• Ensures compliance with all federal and local agencies including the FDA and IRB Maintains strict patient confidentiality
according to HIPAA regulations and applicable law.
• Perform other duties as assigned
Educational Requirements:
High School Diploma/GED (Minimum)
Bachelor's Degree (Preferred)
2 years Clinical research budgeting/billing required
CCRP - Certification In Clinical Research preferred
Physical Demands:
Perform continuous operation of a personal computer for four hours or more.
Use hands and fingers to handle and manipulate objects and/or operate equipment.
Working Title: Sr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute
Department: Angeles Research
Business Entity: Cedars-Sinai Medical Care Foundation
Job Category: Academic/Research
Job Specialty: Contract & Grant Budgeting/Funding
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$28.52 - $44.21
Clinical Research Associate I
Clinical Research Coordinator Job 7 miles from West Covina
Clinical Research Associate I - (10028264) Description 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.
Join us as a Clinical Research Associate, where you'll manage multiple research protocols to ensure efficiency and regulatory compliance while attending clinics as needed. You'll handle data compilation, registration, and submission, and maintain an effective system for data flow. Benefit from mentorship by experienced staff in a dynamic research environment.
As a successful candidate, you will:
· Manages and maintains protocol documentation and regulatory documents for IRB, DSMB, and PRMC/CPRMC.
· Compiles, submits, and processes data and specimens per protocol requirements, ensuring accuracy and safety.
· Establishes and maintains professional relationships with patients and hospital staff while ensuring confidentiality.
· Assists in patient recruitment, protocol-related tests, and evaluations, and performs protocol-specific duties.
· Conducts research activities under close supervision, including laboratory experiments in microbiology, molecular biology, genetics, biochemistry, and informatics.
· Identifies and communicates protocol and data management issues to the supervisor, maintains professional development, and ensures an organized work environment. Qualifications Your qualifications should include:
· Associate's Degree or equivalent experience; one year in a health care setting, preferably research, with medical terminology and writing skills.
· Bachelor's Degree preferred.
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. Primary Location: United States-California-MonroviaJob: Laboratory ResearchWork Force Type: OnsiteShift: DaysJob Posting: Feb 10, 2025Minimum Hourly Rate ($): 32.000000Maximum Hourly Rate ($): 41.554100
Clinical Research Associate
Clinical Research Coordinator Job 19 miles from West Covina
Job Title: Clinical Research Associate - Early Development Oncology - US
Job Contract Type: Full-time
Job Seniority Level: Entry level
As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What will you be doing?
Works on multiple oncology early development trials
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
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.)
Qualifications Needed
US; Located near a major airport
Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
Have a minimum of 1 - 2 years' experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring Oncology Early Development trials
Oncology Phase I and II experience required.
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 40%
To qualify, applicants must be legally authorized to work in the US, 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.
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Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
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Clinical Research Associate
Clinical Research Coordinator Job 27 miles from West Covina
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 Systems
* Experience 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-$120,000
* Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays
#LI-SR1
Clinical Research Associate II
Clinical Research Coordinator Job 27 miles from West Covina
Job Title: Clinical Research Associate II Annual Base Salary: DOE, $90,000-$116,813 along with bonus eligibility and a comprehensive benefits package Our Mission The Ellison Medical Institute, formerly known as the Ellison Institute of Technology Los Angeles, strives to spark innovation, leverage technology, and drive interdisciplinary, patient-centered research to continually enhance health, reimagine and redefine cancer care, and transform lives.
Established in 2016 as a medical research and development center, the Institute features innovation labs for artificial intelligence and molecular analytics and was among the first organizations to vertically integrate the interdisciplinary study and treatment of disease. We offer multifaceted programs, including a preventative medicine and cancer clinic, cross-disciplinary research laboratories, a health policy think-tank, and community outreach and educational programs.
Please visit emila.org for more details.
Job Summary
The Clinical Research Team is responsible for serving as a centralized unit to oversee the clinical research infrastructure and assist investigators in their conduct of translational research projects.
As the Clinical Research Associate II, you'll play a vital role in overseeing the execution of clinical research studies focused on non-therapeutic studies, ensuring compliance with study protocols, regulatory standards, and Good Clinical Practice (GCP). Your contributions will directly support the success of clinical studies and help drive advancements in medical research and patient care.
Why You Should Join Us:
Advance Translational Research: Contribute directly to studies that bridge laboratory discoveries and patient care, supporting innovative research in non-therapeutic clinical studies.
Be at the Core of Scientific Progress: Help ensure the integrity of critical biospecimen data and compliance with research protocols-your work will be foundational to the success of high-impact research.
Collaborate with Leading Experts: Work in a dynamic environment alongside top-tier investigators, clinicians, and multidisciplinary teams committed to improving human health through research.
Job Accountabilities:
Biospecimen Tracking & Inventory Management:
Maintain accurate and complete records of biospecimen collection, handling, and storage activities, including detailed documentation of chain of custody.
Track study supplies.
Protocol Compliance:
Collaborate with study teams to ensure biospecimen collection, processing, and storage procedures align with study protocol and regulatory guidelines
Provides limited patient contact as needed for study.
Quality Control and Assurance:
Implement quality control measures to ensure the integrity, quality, and accuracy of biospecimens and associated clinical data.
Assist in drafting standard operating procedures.
Data Management:
Read and understand clinical data from medical records, extract and enter required data from medical records into electronic data capture database.
Ensure proper documentation of study activities, including clinical data management, and specimen handling.
Work with investigator(s) to analyze and create reports and summaries.
Assist in designing data collection forms.
Provide regular updates to internal teams and external stakeholders regarding study progress, specimen collection, and data quality.
Regulatory Compliance:
Ensure biospecimen related activities adhere to relevant regulatory requirements, such as those outlined by institutional review boards (IRBs) and regulatory agencies.
Assist with regulatory submission to IRB.
Maintain study documentation and regulatory binders, ensuring all required documents are complete and up to date.
ADDITIONAL INFORMATION
Required:
Bachelor's degree with at least two years of clinical research experience in a clinic setting.
Demonstrated effective communication and writing skills.
Ability to manage clinical data and ensure the accuracy and integrity of collected data.
Strong organizational skills, with the ability to manage multiple tasks and meet deadlines.
Excellent communication skills, both written and verbal, for effective interaction with internal teams and stakeholders.
For the safety and health of employees, guests, and patients, the Ellison Medical Institute may mandate vaccination requirements for employment. The Ellison Medical Institute's policies are always subject to review and change to ensure they are appropriate under the circumstances.
The Ellison Medical Institute is an equal opportunity employer. We believe that an inclusive, collaborative team environment is just as important to our mission as stethoscopes and microscopes. We strive to always provide employees a supportive atmosphere, so they feel confident taking creative risks toward innovation. The Ellison Medical Institute values emotional intelligence and communication with empathy and respect for others. We seek to build a diverse group of people who are curious, have a deep sense of responsibility, and the grit needed to achieve excellence.
#LI-DNP
Clinical Research Associate 1
Clinical Research Coordinator Job 27 miles from West Covina
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
Senior Study Coordinator
Clinical Research Coordinator Job 27 miles from West Covina
General Information Press space or enter keys to toggle section visibility Onsite or Remote Flexible Hybrid Work Schedule Monday through Friday, 8:00am - 5:00pm Posted Date 02/06/2025 Salary Range: $39.61 - 63.73 Hourly Employment Type
2 - Staff: Career
Duration
Indefinite
Job #
22416
Primary Duties and Responsibilities
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The Senior Clinical Research Coordinator oversees the operational management of clinical research activities, including study design, setup, execution, and closeout. Responsible for the implementation of research activities across multiple studies, this role involves task prioritization to meet deadlines while ensuring adherence to study protocols and regulatory standards, such as institutional policies, FDA CFR, and ICH GCP. Collaboration with Principal Investigators, ancillary departments, central research teams, sponsors, and institutions is key to ensuring compliant study conduct, financial oversight, and adequate personnel support. Duties may vary based on department needs, study type, and service scope.
Salary: $39.61 - $63.73 hourly
Job Qualifications
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Required:
* Minimum of 4+ years of experience in a clinical research setting
* Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
* Ability to effectively communicate to and interact with patients in a compassionate and kind manner.
* Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
* Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
* Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
* Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.
* Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
* A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
* Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.
* Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to- understand manner.
* Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines.
* Ability to handle confidential information with judgement and discretion.
* High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual.
* Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc..
* Strong knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.
* Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
* Ability to think creatively to develop solutions affecting the full team.
* Experience with FDA processes and procedures.
* Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets
* Bachelor's degree or equivalent experience/training
Preferred:
* Master's degree
As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
Senior Clinical Research Coordinator
Clinical Research Coordinator Job 29 miles from West Covina
Irvine Clinical Research, a research site specializing in late phase CNS clinical trials, is seeking applicants for a Senior Clinical Research Coordinator with extensive clinical trial experience. The Senior CRC will work as a primary coordinator on Phase II/III clinical trials in Neurology and Psychiatry.
Job DutiesCoordinate the day-to-day clinical operations of clinical research studies Perform study procedures in accordance with GCP and study protocols Organize and maintain paper and electronic study data in a complete and correct manner Work closely with recruitment and prescreening teams to meet study enrollment goals Conduct diagnostic, efficacy, and safety assessments as needed Mentor and lead less experienced coordinators and/or research assistants Take ownership of team productivity (enrollment) and quality metrics
Job RequirementsFive (5) or more years of industry-sponsored drug trial experience Demonstrated ability to work on high-enrolling Phase II/III clinical trials Attention to detail and the ability to handle multiple tasks with precision Demonstrated ability to work accurately and quickly with CTMSA command of professional spoken and written English
$95,000 - $95,000 a year
Hours and CompensationThis is a full-time employment position based in-person at our clinic in the Alzheimer's Orange County building in Irvine.The starting salary for this position is $95,000 per year. Higher salary is negotiable with candidates who have a valid nursing license (RN or LVN) and skill in infusions.The company pays for 100% of health/dental/vision individual insurance costs for eligible full-time employees. Vacation (PTO) is earned at a rate of 3 weeks per year.