Clinical Research Associate I, Per Diem - Castellon-Lopez Lab
Clinical research associate job in Los Angeles, CA
Job DescriptionPrimary Duties and Responsibilities
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.
QualificationsRequirements:
High School Diploma/GED required.
Preferred:
Bachelor's Degree preferred.
1 year Clinical research related experience preferred.
Req ID : 10495
Working Title : Clinical Research Associate I, Per Diem - Castellon-Lopez Lab
Department : Cancer - Research Center Health Equity
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $19.50 - $32.86
Clinical Research Informatician
Clinical research associate job in Los Angeles, CA
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 4 years' experience in clinical research
Minimum 4 years' experience in clinical informatics
Minimum 4 years' experience in information technology and/or in academic healthcare setting
Experience with clinical operations, Health Information Management, or care management.
Experience with clinical definitions, ontologies, dictionaries, and taxonomies required.
Experience with clinical standards and coding.
Experience with KPIs as they relate to clinical areas.
Experience implementing new technologies in clinical areas.
General clinical experience accepted, including experience as an MD, NP, PA, or RN.
Experience serving as a liaison between clinicians/researchers and IT.
Experience interpreting healthcare data using self-service tools or programming languages such as SQL and Python.
Accountabilities:
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.
R&D & Sales Project Coordinator
Clinical research associate job in Los Angeles, CA
Don Lee Farms creates premium burgers, bowls, and tacos for America's top markets. As a multigenerational family-run company, we specialize in delivering delicious and convenient food options. Our products can be found at leading retailers like Trader Joe's, Costco, Walmart, and Sam's Club. Whether under the Don Lee Farms brand or other store labels, we make mealtimes hassle-free with our quality foods.
About the Role
We are seeking a R&D & Sales Project Coordinator to support our Sales and R&D teams in moving projects forward, preparing for customer meetings, and ensuring smooth execution of product launches. This role is ideal for someone early in their career who thrives in a fast-paced environment, enjoys problem-solving, and wants a clear path to grow into sales or account management at Don Lee Farms. This is an in-person role.
Key Responsibilities
Work closely with the Sales and R&D teams to advance up to 100 projects at a time from concept to launch.
Enter and maintain accurate product and project data in customer portals.
Coordinate across departments (R&D, operations, quality) to ensure deadlines and deliverables are met.
Join customer meetings and presentations, presenting product in support of the sales team, capturing action items, and ensuring timely follow-through (travel required).
Support the sales team with materials, presentations, and follow-up for key customer meetings.
Assist with order tracking, reporting, and general sales support as needed.
Skills & Abilities
Strong organizational skills and attention to detail.
Excellent communication and interpersonal skills; comfortable engaging with customers and internal teams.
Ability to manage multiple priorities with a proactive, solution-oriented mindset.
Proficiency in Microsoft Office (Excel, PowerPoint, Outlook) and ability to learn new systems quickly.
Commitment to developing a long-term career with Don Lee Farms in sales and commercialization.
Qualifications
Bachelor's degree preferred, or equivalent experience.
1+ year of professional experience (internships and part-time work welcome).
The expected base salary for this position is between $60,000 and $125,000 annually, depending on relevant experience and qualifications.
Equal Opportunity Statement
Don Lee Farms is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by law. Employment is contingent upon completion of a background check and verification of eligibility to work in the United States.
Clinical Research Coordinator - 247967
Clinical research associate job in Los Angeles, CA
Clinical Research Coordinator in Los Angeles, CA (91402)
We are seeking a detail-oriented Clinical Research Coordinator to oversee and support all phases of clinical trials involving investigational drugs and medical devices. This role is responsible for ensuring smooth trial operations from initiation through closeout, while upholding the highest standards of compliance, data quality, and patient care. The ideal candidate will be proactive, organized, and knowledgeable in regulatory guidelines governing clinical research.
Responsibilities:
Manage all aspects of study coordination including participant recruitment, informed consent, visit scheduling, and protocol compliance.
Guide participants through clinical trial procedures, ensuring adherence to study timelines and ethical standards.
Maintain thorough and accurate records of study visits, observations, test results, and patient-reported outcomes in source documents and sponsor databases.
Monitor and track investigational product inventory, laboratory supplies, and other study materials, ensuring availability and proper documentation.
Collaborate closely with investigators, study teams, sponsors, and regulatory personnel to support ongoing communication and issue resolution.
Prepare and submit timely reports, including adverse event and serious adverse event documentation, in accordance with sponsor and regulatory requirements.
Ensure proper handling of confidential information and maintain HIPAA compliance at all times.
Participate in site selection visits, sponsor monitoring visits, and audit preparation activities.
Stay current with evolving industry regulations and standards through training sessions, webinars, and professional development opportunities.
Represent the research site in a professional and respectful manner in all internal and external interactions.
Qualifications:
Bachelor's degree preferred, but equivalent experience will be considered.
At least 2 years of experience as a Clinical Research Coordinator
Must have Oncology Experience
Strong understanding of GCP, ICH guidelines, and IRB processes.
Excellent organizational skills, attention to detail, and ability to manage multiple studies simultaneously.
Strong communication and interpersonal skills to interact with diverse teams and patient populations.
Additional Details:
Title: Clinical Research Coordinator
Location: Los Angeles, CA (91402)
Employment: Direct Hire
Hours: Monday-Friday; 8AM-5PM; Onsite 5 Days a Week
Pay: $70,000-$79,000 Annual Salary (Dependent on background and years of experience)
Clinical Research Coordinator
Clinical research associate job in Los Angeles, CA
Highlights
$70,000 - $79,000 annual salary based on experience
Great benefits including 401k w/match and 15 days PTO
Consistent schedule, no overnights or weekends
Work with cutting edge oncology research trials
About Our Client
Our client is a fast growing site network that currently has over 30 sites and constantly expanding! They focus on diversity in their trials including therapeutic areas: oncology, cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. Their sites conduct studies spanning Phases I-IV and they've been awarded for excellence in recruitment and recognized in the industry for retention, a best-in-class experience for patients and sponsors.
Responsibilities
As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process!
Conduct procedures such as vital signs, blood draws, EKGs, and scans.
Patient recruitment, enrollment, scheduling, and consent
Lab procedures and shipments
Maintain GCP and follow protocols
Data management in EDC systems
Overall coordination of the study from start up to close out
Focus on oncology based research studies
Qualifications:
2+ years of experience working as a CRC on sponsor backed clinical trials
Phlebotomy and lab processing experience (ability to perform without supervision)
Ability to work on site M-F on site (there is no remote or hybrid days)
Experience working with Oncology clinical trials
Clinical Research Coordinator
Clinical research associate job in Los Angeles, CA
3Sync Research has been dedicated to serving patients' needs since its establishment in 2021. The company focuses on enhancing patient lives by delivering high-quality services in clinical trials. With a commitment to compliance and a strong emphasis on compassionate care, 3Sync Research strives to set a standard of excellence in clinical research. The organization is grounded in the belief that ethical and empathetic practices lead to better outcomes for patients and advancements in healthcare.
Role Description
This is a contract, on-site role for a Clinical Research Coordinator located in Los Angeles, CA. The Clinical Research Coordinator will manage clinical trials, oversee research processes, and ensure compliance with relevant protocols. Responsibilities include obtaining informed consent from participants, managing research documentation, maintaining accurate and organized records, and ensuring adherence to clinical trial protocols. The coordinator will play a vital role in ensuring ethical and efficient execution of research projects with a patient-centered approach.
Qualifications
Experience with Informed Consent processes and a thorough understanding of participant rights and confidentiality
Comprehensive knowledge and experience with Protocols and Clinical Trials
Proven track record of Clinical Research Experience and conducting research studies
Strong organizational, communication, and problem-solving skills
Detail-oriented with the ability to manage multiple tasks and deadlines
Bachelor's degree in a related field; additional certifications in clinical research are a plus
Familiarity with regulatory guidelines for clinical research is preferred
Clinical Research Coordinator
Clinical research associate job in Los Angeles, CA
Biopharma Informatic is seeking an experienced Spanish-speaking Clinical Research Coordinator (CRC) with phlebotomy experience to join our team. This is a fully onsite role and is open only to candidates who are local to the area.
We are specifically seeking candidates with hands-on Clinical Research Coordinator experience within physician office or private practice clinical trial settings. Experience obtained exclusively in hospital or university-based research environments does not fully align with the workflows, pace, and operational structure of this role.
Required Spanish Fluency - Important Notice:
Due to the needs of our patient population and the communication demands of this role, Spanish fluency is a strict requirement. Candidates must be able to communicate professionally and fully consent patients in Spanish without assistance. If you are not fully fluent in Spanish, please do not apply for this position.
If you are not a Spanish speaker but are interested in joining Biopharma Informatic, we encourage you to explore and apply to any of our other open positions that align with your background. Please submit your application anytime through our careers portal: đź”— *************************************
Key Responsibilities:
Lead the coordination and execution of clinical trials across all phases: start-up, enrollment, maintenance, and close-out.
Ensure proper receipt, handling, and accountability of investigational product (IP).
Conduct and document the informed consent process in compliance with protocols and regulations.
Serve as a liaison between physicians, study sponsors, and internal team members.
Achieve or exceed study enrollment targets at assigned sites.
Complete accurate and timely data entry in electronic data capture systems.
Resolve data queries promptly to support project timelines and database lock.
Maintain compliance with GCP, company SOPs, and industry regulations.
Qualifications:
2-5 years of Clinical Research Coordinator experience in a physician practice or private research setting.
Spanish Fluency - must be able to consent patient without translator
Phlebotomy experience is required
Strong understanding of investigational product (IP) receipt, handling, and accountability.
Proven experience conducting the informed consent process experience preferred
Demonstrated ability to independently coordinate and manage clinical trials.
Excellent organizational, communication, and problem-solving skills.
Must be local to the area (onsite only; no relocation or remote work).
Clinical Research Associate
Clinical research associate job in Los Angeles, CA
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 I-CA Heart Foundation - Beverly Hills, CA
Clinical research associate job in Beverly Hills, CA
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.
The California Heart Center is an affiliate of the Cedars-Sinai Heart Institute, located in Beverly Hills, California, 90211. We offer the full spectrum of cardiology care, including, Cardiac Evaluation/Adult Cardiology, Heart Failure Management, Interventional Cardiology, Nuclear Cardiology and Echocardiography.
In addition to our private cardiology practice, CA Heart Center physicians are active clinical research investigators and hold leadership positions in heart failure, heart transplantation, and mechanical cardiac assist devices and heart failure/transplant clinical research at the Cedars-Sinai Heart Institute (CSHI). In addition to its highly-regarded cardiology program, CSHI is doing groundbreaking work in other important cardiovascular areas, including cardiac stem cell transplants and non-surgical heart valve replacements. In partnership with CSHI, the California Heart Center offers a multi-disciplinary and integrated approach to the care of patients with heart disease.
Why work here?
Beyond an outstanding benefits package and competitive salaries, we take pride in hiring the best, most committed employees. Our staff reflects the culturally and ethnically diverse community we serve. They are proof of our dedication to creating a multifaceted, inclusive environment that fuels innovation and the gold standard of care we strive for.
Are you ready to be a part of breakthrough research?
The Clinical Research Associate I 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 research objectives through tasks like data collection, candidate evaluation, participant scheduling, IRB assistance, budget management, and regulatory compliance.
Primary Duties & 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 the sponsors provide.
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.
Assists with prescreening of potential research participants for various clinical trials.
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.
Additional Qualifications/Responsibilities
Qualifications
Education:
High School Diploma/GED is required. Bachelor's degree in Science, Sociology, or a related field preferred.
Experience and Skills:
No experience required. One (1) year of clinical research related experience is preferred.
Ability to interpret and apply knowledge of State, Federal, and Agency standards to align with regulations.
Ability to convey and/or receive written/verbal information to/from various audiences in different formats.
Minimum Salary
21.29
Maximum Salary
33.00
Clinical Research Associate I
Clinical research associate job in Monrovia, CA
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
Auto-ApplyClinical Research Associate 1
Clinical research associate job in Los Angeles, CA
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
Clinical Research Associate - NAMSA Future Openings USA
Clinical research associate job in Irvine, CA
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
* Act with integrity in everything we do.
* Provide best-in-class customer experiences.
* Develop superior talent and deliver expertise.
* Respond with agility and provide timely results.
* Embrace collaboration, diverse perspectives and ideas.
Job Description:
* Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
* Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
* May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
* Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
* Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
* Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
* Performs study-related training.
* Manages the development and maintenance of study documents, processes and systems as assigned.
* Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
* Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
* Attends internal and external meetings as required.
* Provides all job-related progress reports and visit documentation as required.
* May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
* OUS: Prepares and coordinates submissions to regulatory authorities.
* May perform other activities as assigned.
Qualifications & Technical Competencies:
* Fluency in English and local language, if different, required.
* Higher education degree or equivalent education, training, and experience.
* Preferred 2 years clinical trial experience.
* Preferred monitoring experience.
* Able to work independently once trained.
* Good verbal and written communication skills.
* Strong organizational skills.
* Basic computer proficiency.
* Understanding of clinical research processes and regulations.
* Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
Working Conditions:
* Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.
* 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.
* While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.
* Extensive use of a computer keyboard.
Pay Range Minimum:
$54,400.00
Pay Range Target:
$80,100.00
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
NAMSA is an equal employment opportunity company.
NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.
Fair Chance Employment Statement:
At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history.
Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:
* May operate equipment
* Records data timely and accurately
* May analyze and interpret data
* Conducts studies on medical devices that have an impact on human life
A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
Auto-ApplyClinical Site Monitor
Clinical research associate job in Los Angeles, CA
Title: Clinical Site Monitor Duration: 6 Months (Possibility of extension) Responsibilities • Perform/facilitate time-efficient pre-study initiation process. • Orient site personnel to study protocol/procedures. • Monitor compliance to FDA Regulations and Client SOP.
• Manage study site activities through frequent on-site visits and telephone contracts
• Position located in Los Angeles, CA area and will manage sites in this area and help region cover Northern and Southern California as needed.
Requirements:
• Direct multi-therapeutic site monitoring experience, including oncology experience
• On-site monitoring experience required of multiple protocols in multiple therapeutic areas, including oncology.
• Please ensure the Therapeutic Areas and the # of studies handled by the candidate is also listed on the resume.
Qualifications
• Direct multi-therapeutic site monitoring experience, including oncology experience
• On-site monitoring experience required of multiple protocols in multiple therapeutic areas, including oncology.
• Please ensure the Therapeutic Areas and the # of studies handled by the candidate is also listed on the resume.
Additional Information
This Job is with one of my pharmaceutical client.
Clinical Site Manager - Clinical Research Monitor (So. California)
Clinical research associate job in Loma Linda, CA
Clinical Site Manager - Southern California
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
Purpose:
A Clinical Site Manager (CSM) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
Site Selection
Pre-trial assessment
Site level Study Participant recruitment/retention plans
Site Activation/Initiation
On-site and remote monitoring
Overall site relationship management in collaboration with other sponsor roles that interact with the site
Close-out activities
Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Essential Job Responsibilities:
Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
Develops meaningful site relationships through consistent collaborative communication and engagement.
May participate in site feasibility and/or pre-trial site assessment visits.
Attends/participates in investigator meetings as needed.
May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
Ensures site non-IMP study supplies are adequate for trial conduct.
Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
Oversees the appropriate destruction of clinical supplies.
Ensures site staff complete data entry and resolve queries within expected timelines.
Ensures validity and completeness of data collected at trial sites.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
Prepares trial sites for close out, conduct final close out visit.
Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
Sr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute
Clinical research associate job in Monterey Park, CA
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
Senior Clinical Research Coordinator (CRC)
Clinical research associate job in Orange, CA
Job Title: Senior Clinical Research Coordinator (Liver Trials) Job Type: Full\-Time | On\-Site
Job Location: Orange, CA
Job Salary: $90,000\-$100,000 per year (based on experience)
Industry: Clinical Research | Hepatology | Phase I-IV Trials
About Us:
We're a fast\-paced, compliance\-driven research clinic specializing in liver disease trials-from NASH and cirrhosis to hepatocellular carcinoma. Our team partners with leading sponsors and CROs to deliver high\-quality, audit\-ready data and compassionate patient care.
Position Overview:
This is an on\-site position in Orange, CA, and applicants must reside within a commutable distance of 50 miles or less or be able to independently relocate. THIS IS NOT A REMOTE POSITION.
We're seeking a Senior Clinical Research Coordinator (CRC) with hands\-on experience in liver\-focused clinical trials. You'll lead study execution, regulatory coordination, and patient engagement across multiple protocols.
MUST HAVE \- Experience in CRC in Liver\/GI\/Obesity studies
Key Responsibilities
• Coordinate Phase I-IV liver trials, including screening, enrollment, and follow\-up
• Manage regulatory submissions (IRB, CPHS), source documentation, and AE reporting
• Oversee biospecimen handling and lab coordination
• Maintain CTMS and EDC systems (REDCap, Medidata, etc.)
• Mentor junior CRCs and support cross\-functional study teams
Requirements Qualifications
• 3-5+ years of CRC experience in liver\/hepatology trials
• Strong knowledge of FDA, ICH\-GCP, and HIPAA regulations
• Proficiency in CTMS, EDC platforms, and protocol adherence
• Excellent communication and documentation skills
• Bilingual (Spanish\/English) preferred
• Familiarity with California specific regulations
Certifications
• GCP Training (Required)
• HIPAA & Human Subjects Protection (Required)
• CPHS Compliance Training (Required)
• CCRC (Certified Clinical Research Coordinator) (Preferred)
• CCRP (Certified Clinical Research Professional) (Preferred)
Benefits • Competitive salary + performance bonuses
• Health, dental, and vision coverage
• Paid training and certification support
• Career growth in a high\-impact research setting
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Senior Clinical Research Coordinator
Clinical research associate job in Riverside, CA
At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion.
Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple locations serving Southern California, including San Diego and Riverside, each Artemis site is fully equipped to conduct complex clinical research trials.
Want to be a part of a growing company that's making a difference in our world? Look no further than Artemis Institute for Clinical Research! You'll enjoy a friendly and exciting culture with opportunities for growth and advancement. We offer the following generous benefits to our full-time employees:
A range of PPO and HMO medical plans
PPO and HMO dental plans
Vision coverage, long term disability plan, and life/AD&D coverage
401k plan
Paid holidays and paid time off
A welcoming work environment
The Role
We are seeking an experienced Clinical Research Coordinator/Clinical Research Coordinator III for our Artemis Institute of Research clinical trial site located in Riverside, California. Under the supervision of the Site Director, the Senior Clinical Research Coordinator is responsible for the conduct of research protocols, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines. The Senior Clinical Research Coordinator manages study conduct from planning through study closeout.
Position Type: Full Time
Pay Range: $76,000-$90,000/yr
Location: Riverside, CA
Work Schedule: Monday through Friday, 9:30am-6:00pm
Responsibilities:
In-depth understanding of Pharmaceutical Sponsor/Industry initiated FDA studies in order to conduct the study with excellent quality
Managing all aspects of a study including participating in the informed consent process, coordinating and performing all visit study procedures per the protocol, entering data and query resolution, Investigational Product management, and managing all study related supplies and equipment, hosting monitoring visits, and attending investigator meetings
Experience managing multiple studies as the primary coordinator and someone ready to take the next step in managing people
Providing the highest level of care for study patients and delivering excellent customer service to the pharmaceutical clients
Qualifications:
Nursing license, medical assistant certificate or registration preferred
Minimum of two years of experience as a designated Clinical Research Coordinator on clinical trials required; sponsor-initiated and pharma clinical trials preferred
Previous clinical experience in a hands-on patient-facing role required
Commitment and ability to deliver excellent customer service
Excellent communication, punctual and responsible
Extremely well organized
Excellent verbal and written communication skills
Trustworthy, reliable; attentive to details
Mature and pleasant demeanor
Willingness to learn new tasks and grow with the company
California Pay Range
$76,000 - $90,000 USD
Auto-ApplyIndependent Study Coordinator
Clinical research associate job in Palmdale, CA
JOB TITLE: Independent Studies Coordinator REPORTS TO: School Director CLASSIFICATION: Exempt / Full-Time
The Independent Studies Coordinator is responsible for designing, managing, and implementing the independent study program at Academy of Creative Technologies - Antelope Valley. This role ensures academic integrity, compliance with California Ed Code, and personalized learning for students enrolled in independent study. The Coordinator will work in collaboration with instructional staff, support teams, and families to develop and monitor individualized learning plans that align with student goals, state standards, and school expectations.
Key Responsibilities
Coordinate all aspects of the independent study program, including intake, orientation, curriculum planning, and weekly check-ins with students and families.
Create and maintain individualized learning contracts and master agreements in compliance with California Education Code requirements.
Monitor student progress, attendance, work product submissions, and engagement to ensure satisfactory academic achievement.
Work directly with students to provide guidance, instruction, and academic support in completing assigned independent study coursework.
Collaborate with facilitators, education specialists, and the Care Team to support differentiation, interventions, and accommodations for students in independent study.
Ensure timely submission of student work samples and documentation for state reporting, audits, and internal recordkeeping.
Use educational technology platforms to track assignments, communication, and student performance (e.g., Google Workspace, School Pathways, Edmentum).
Analyze student performance data to recommend interventions or transitions between independent study and general education settings as appropriate.
Meet regularly with the School Director and instructional leadership to align independent study with broader school goals and instructional initiatives.
Coordinate and oversee independent study meetings, including monthly reviews, student progress conferences, and mid-year reassessments.
Maintain accurate and up-to-date records, including academic transcripts, credits earned, graduation progress, and assessment participation.
Provide training and support to staff and families regarding independent study policies, procedures, and expectations.
Serve as a liaison with external partners, home educators, and postsecondary institutions when applicable.
Qualifications
Bachelor's Degree in Education, Curriculum & Instruction, or related field required; teaching credential or administrative credential preferred.
Minimum 3 years of experience in a K-12 educational setting, with prior experience in independent study, personalized learning, or online instruction strongly preferred.
Strong working knowledge of California independent study laws, instructional design, and alternative education models.
Familiarity with Individualized Education Programs (IEPs), 504 Plans, and Response to Intervention (RTI) processes.
Proficient in student data systems, academic monitoring platforms, and digital learning tools.
Demonstrated ability to work with diverse student populations and develop inclusive learning plans.
Excellent organizational, interpersonal, and communication skills.
Ability to work independently and collaboratively in a fast-paced, evolving school environment.
Commitment to the mission, vision, and educational philosophy of Academy of Creative Technologies - Antelope Valley.
Compensation
Compensation is commensurate with experience and placement on the appropriate pay rate chart.
Application Requirements
Please include a cover letter, resume, and any relevant credentials or documentation of prior work in independent study, alternative education, or student case management.
Academy of Creative Technologies - Antelope Valley is an equal opportunity employer committed to fostering a diverse and inclusive educational community. We encourage candidates from all backgrounds to apply.
Study Moderator - Los Angeles, CA
Clinical research associate job in Los Angeles, CA
Description and Requirements JOB STATUS: Full-time WORK SCHEDULE: Mon - Fri Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Los Angeles, CA, with additional support staff on-site to manage participant intake and provide technical support.
Main Responsibilities
* Receive participants at work and guide them through the video study in a controlled environment
* Ensure all recordings are done per project guidelines and upload the data
* Have all participants complete a survey at the end of each session
* Follow COVID-19 sanitization procedures after each session
* Represent and promote the TELUS AI brand
Minimum Requirements
* Technical/troubleshooting skills; address fundamental problems with launching apps and uploading data
* Familiarity with iOS and Mac OS
* Experience with data collection and data management
* Experience with video recording
* Able to commit to a weekly schedule for the duration of the project
* Ability to interact professionally with project participants
* Experience with progress tracking and reporting, comfortable with Excel or Sheets
Rate: $33.00 per hour
TELUS International Values:
TELUS International recognizes and embraces the importance of values in our ever-changing workplace. To be successful, all applicants must demonstrate behaviors that are reflective of our values:
* We embrace change and initiate opportunity
* We have a passion for growth
* We believe in spirited teamwork
* We have the courage to innovate
At TELUS International, we are committed to diversity and equitable access to employment opportunities based on ability.
TELUS Digital will never ask for any monetary deposit, credit card information, or bank account information to complete a job application. When emailing candidates, our recruitment and sourcing teams only use email addresses that end with telusdigital.com or telusdigital.ai. If you are unsure whether a job offer is legitimate or suspect that TELUS Digital's business name is being used for recruitment fraud, please report this immediately to our Talent Acquisition Team at TINA_**********************************.
Additional Job Description
Moderators are expected to interact directly with study participants using provided study protocols and managing the data collected during each session. Moderators will report to the Project Manager and Project Coordinator. Training will be provided before the start of data collection. Sessions occur onsite in Sunnyvale, CA, with additional support staff on-site to manage participant intake and provide technical support.
EEO Statement
At TELUS Digital, we enable customer experience innovation through spirited teamwork, agile thinking, and a caring culture that puts customers first. TELUS Digital is the global arm of TELUS Corporation, one of the largest telecommunications service providers in Canada. We deliver contact center and business process outsourcing (BPO) solutions to some of the world's largest corporations in the consumer electronics, finance, telecommunications and utilities sectors. With global call center delivery capabilities, our multi-shore, multi-language programs offer safe, secure infrastructure, value-based pricing, skills-based resources and exceptional customer service - all backed by TELUS, our multi-billion dollar telecommunications parent.
Equal Opportunity Employer
At TELUS Digital, we are proud to be an equal opportunity employer and are committed to creating a diverse and inclusive workplace. All aspects of employment, including the decision to hire and promote, are based on applicants' qualifications, merits, competence and performance without regard to any characteristic related to diversity.
Travel Clinical Research Coordinator
Clinical research associate job in Los Angeles, CA
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes A Difference
The Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members.
The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations.
How You'll Make An Impact
* Study Preparation:
* Ability to understand and follow institutional SOPs
* Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.
* Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct
* Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff
* Assist with planning and creation of appropriate recruitment and marketing materials
* Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc.
* Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies
* Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives
* Assist in the creation or review of protocol specific source documents
* Determine facility, equipment and outsource vendor requirements and availability
* Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance
* Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks
* Study Management:
* Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety.
* Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies
* Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records
* Collect and evaluate concomitant medications
* Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual.
* Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
* Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave
* Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
* Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion
* Maintain effective relationships with study participants and other Care Access Research personnel
* Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
* Strong and clear communication skills, both verbally and in writing
* Accept accountability for actions and function independently
* Patient Coordination:
* Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment
* Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial
* Administer delegated study questionnaires, where appropriate.
* Collect and evaluate medical records with the support of medically qualified members of the study team.
* Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol
* Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
* Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion
* Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs)
* Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol
* Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround
* Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance.
* Monitor patient progress on study medication
* Documentation:
* Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP
* Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion.
* Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart
* Accurately transcribe data to CRF or EDC.
* Resolve data management queries and correct source data as needed
* Record protocol exemptions and deviations as appropriate with sponsor.
* Complete Note(s)-to-File for patient chart and regulatory filing if necessary
* Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing
* Maintain copies of patient-specific correspondence in source charts
* Assist regulatory personnel with completion of continuing/final review reports
* Perform other duties as assigned.
The Expertise Required
* Excellent working knowledge of clinical trials, medicine and research terminology
* Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+
* Ability to communicate and work effectively with a diverse team of professionals
* Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
* Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel.
* Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc.
* Critical thinker and problem solver
* Friendly, outgoing personality; maintain a positive attitude under pressure
* High level of self-motivation and energy
* Excellent professional writing and communication skills
* Ability to work independently in a fast-paced environment with minimal supervision
Certifications/Licenses, Education, and Experience:
* BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred
* RN or LPN preferred
* Research Professional Certification- CRCC or exam eligibility preferred
* A minimum of 3 to 4 years Clinical Research experience
* A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred.
How We Work Together
* Location: This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. Candidates must be willing to travel 75% of the time nationwide.
* Travel: Duties may require travel in the following models:
* Two weeks on / One week off deployments
* Temporary Event Support (3-7-day deployment durations)
* Weekly deployments (one week on, 2-5 days off).
* Frequency and length of travel may depend on the length and location of study, site, and event.
* Deployments normalize to a 32 to 42-hour work week on average.
The expected salary range for this role is $70,000-$100,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off.
Benefits & Perks (US Full Time Employees Only)
* Paid Time Off (PTO) and Company Paid Holidays
* 100% Employer paid medical, dental, and vision insurance plan options
* Health Savings Account and Flexible Spending Accounts
* Bi-weekly HSA employer contribution
* Company paid Short-Term Disability and Long-Term Disability
* 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************