Senior Clinical Research Associate jobs at Kelly Services - 393 jobs

A clinical-stage biotechnology company is seeking an experienced Clinical Scientist (Director level) to support early stage oncology clinical development programs. This is a 9-month contract role, working hand in hand with the clinical lead to provide medical and scientific expertise on multiple clinical programs. Location: South San Francisco or San Diego (hybrid/onsite) Key Responsibilities Support clinical development strategy and author clinical development plans Draft and review protocol synopses, protocols, amendments, and informed consent forms Collaborate with Clinical Operations on site selection, start-up, and execution Contribute to investigator brochures, clinical study reports, and regulatory submissions Review and interpret clinical and safety data, including SAEs Support medical monitoring activities for Phase 2-3 studies Prepare study materials, slide decks, and support publications and presentations Participate in advisory boards, KOL engagement, and competitive landscape analysis Support health authority interactions, audits, and submissions Qualifications Bachelor's degree required; advanced degree (MS, MD, PharmD, PhD, NP) preferred Minimum 4 years of industry experience in early stage, oncology clinical development Hands-on experience across clinical trial lifecycle (start-up through CSR) Strong protocol development, data interpretation, and safety monitoring experience Knowledge of GCP and regulatory standards Excellent communication skills and ability to thrive in a fast-paced environment Terms: 9-month contract position, paying up to $115/hr DOE Estimated Min Rate: $80.50 Estimated Max Rate: $115.00 What's In It for You? We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include: Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week) Health Savings Account (HSA) (for employees working 20+ hours per week) Life & Disability Insurance (for employees working 20+ hours per week) MetLife Voluntary Benefits Employee Assistance Program (EAP) 401K Retirement Savings Plan Direct Deposit & weekly epayroll Referral Bonus Programs Certification and training opportunities Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit ************************************************ to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: **********************************

The NSABP Foundation has an opening for Clinical Research Associate - Level 3. This is a hybrid position located in Pittsburgh, PA requiring 3 days in the office and 2 days remote work. PURPOSE This role supports breast and colorectal cancer clinical trial operations and the primary deliverables of ensuring accrual to NSABP protocols, data integrity and regulatory compliance. The Clinical Research Associate, Level 3 role is one that includes responsibilities both as an individual contributor and leader. Leadership responsibilities focus online management of study monitors. ESSENTIAL FUNCTIONS Actively plans, executes and assesses performance of activities across the life span of study. Ensures timely study start-up. Examples include but are not limited to study timeline start-up development, site selection and Principal Investigator review. Assists with site activation requirements including ICF review, site access to study platforms and other needs as they arise. Facilitates daily or weekly team huddles to assess, plan, review and prioritize activities to ensure timely site activation, accrual, metrics review, compliance with CMP and other study requirements and audit prep. Completes required trainings with appropriate documentation. Develops relationships with site staff and NSABP monitors. Acts as a liaison for NSABP, site staff and external partners. Conducts weekly performance metrics review, identifies gaps and initiates contact with study monitor to review performance as needed. Examples include the number of queries, query resolution, source data verification, protocol deviation reporting and other study specific metrics. Responsible for providing regular metrics assessment to leadership team. Identifies key metrics with poor performance and develops an action plan to remediate the issue. Develops and implements recruitment strategies to ensure accrual targets are met. Ensures site initiation visits, interim monitoring visits and close out visits are compliant with the Clinical Monitoring Plan (CMP). Reviews and approves itineraries to ensure CMP compliance and associated expense reports. Follows Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP and ICH guidelines. Develops, writes and implements Study Start-Up Plans, Clinical Monitoring Plans, Roles and Responsibilities grids and other study-specific documents. Collaborates with clinical research organizations and centralized services such as laboratories. Collaborates with data management regarding CRF development and UAT testing. Acts as a resource to sites and investigators. Accompanies study monitors within 3 months of onboarding to confirm that the CMP is implemented accurately, and that PI/site needs are met. Reviews SIV and monitoring reports to ensure expected quality compliance standards are met. These include compliance with CMP, SOPs, WIs and training requirements. Supports study monitors with resolution of significant site issues. Performs other job-related duties as assigned. OTHER RESPONSIBILITIES Knowledge of randomized clinical trials principles and procedures. Knowledge of federal and state regulations and guidelines pertaining to the conduct of clinical trials. Knowledge of the infrastructure and operational characteristics of successful patient accrual related to site and study management. EXPERIENCE/SKILLS Bachelor's degree required. Prior CRA experience required. Research certification strongly preferred Prior experience at CRO strongly preferred. Familiarity with electronic TMF, EDC and CTMS systems required. Strong verbal, written and organizational skills with a team-oriented approach required. Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment. Proficiency in Microsoft Office Suite HYBRID POSITION This is a hybrid position consisting of 2 days of remote work (Wednesday and Friday) and 3 days onsite in our office in Pittsburgh, PA (Monday, Tuesday and Thursday). The NSABP Foundation, Inc. is an Equal Employment Opportunity and Affirmative Action Employer committed to the value of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, national origin, physical or mental disability, protected veterans, genetic information, and sexual orientation.

Contributor to the profitable management of the clinical research business, consistent with company principles, strategies, and objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials including management of regulatory, clinical operations, and line management of Project Managers and support roles. Performs diverse managerial responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes. Works closely with the Principal Investigator and Managing Partner to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective. In executing these position responsibilities, the Site Director is guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company standard operating procedures and policies. Key Activities: Planning and Management: Supports Managing Partner implementation of business plans for achieving the strategic and tactical goals and objectives of the line of business. Contributor to the business plan in collaboration with the PI and Managing Partner Contributor to the financial performance of the line of business. Enforce standardized policies, procedures, and performance metrics to ensure consistency and excellence in research operations, data management, and regulatory submissions and activities. Foster a culture of accountability, collaboration, and continuous learning. Study Operations: Manages all aspects of clinical research studies and related office operations. Interviews, supports hiring process trains, , and manages Clinical Research Coordinators, Assistant Clinical Research Coordinators, Data Entry Specialists, Psychometric Raters, and the Front Desk Office Coordinators and Specialists. Evaluate staff performance, identify growth opportunities, and ensure role clarity. Oversees day-to-day clinical research operations, including protocol implementation, data management, and regulatory submissions and oversight. Manages the processes of informed consent, subject visits, source document, Case Report Form and other document preparation and disposition. Completes study visits and pre-screening visits of participants as business needs dictate. Partner with PI, Managing Partner, and research staff to ensure successful execution of clinical trials and adherence to timelines and budgets. Proactively identify operational risks and implement mitigation strategies to safeguard research quality, compliance, and patient safety. Maintain readiness for sponsor and regulatory inspections, serving as subject matter expert on compliance and quality matters. Serve as Point of Contact for internal and external audits, monitor compliance trends, and implement corrective and preventative actions to uphold operational integrity. Subject Recruitment: Assists Managing Partner with the implementation of plans for recruiting subjects into each study. Includes coordination and oversight of site metrics Includes collaboration with recruitment department as designated by Managing Partner Regulatory Oversight: Oversees regulatory activities for all studies including timelines, personnel involved, and key activities. Responsible for delivery of regulatory activities and site level metrics. Ensures that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH). Skills Required: B.A. or B.S. required;. A minimum of 7 years of progressive clinical trial management experience is required including prior Clinical Research Coordinator experience and experience in line management and/or leading teams Excellent communication, interpersonal, and problem solving skills with proven track record of implementing quality improvement initiatives, training programs, and regulatory compliance strategies in clinical research settings. Understanding of Clinical Research Requirements:Demonstrated knowledge with clinical research study processes and requirements. Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines. Thoroughness and Accuracy: Able to collect, organize, interpret, and record detailed information as required by study sponsors and regulatory and review agencies. Communication: Able to communicate with direct reports, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in clinical operations and project management. Management: Able to manage a staff of clinical professionals and create a productive, satisfying work environment. Independence: Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, this job description, and company policy. Adaptability: Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change. Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations.

Job Title: Pharmaceutical Scientist Type of Work: On-Site Schedule: Second Shift (2:00 p.m. - 11:00 p.m.) Type of Contract: Temp-to-Perm Pay Rate: Competitive - commensurate with experience and technical proficiency Department: Research & Development - Analytical & Formulation About the Opportunity A fast-growing pharmaceutical research and manufacturing organization is expanding its R&D operations in Coral Springs, FL. We are seeking motivated Scientists and Associate Scientists (Levels I & II) to support formulation and analytical development for inhalation-based drug products, including MDI, DPI, and nasal spray formulations. These are hands-on laboratory roles in a GMP-regulated environment. Successful candidates will demonstrate strong documentation skills (GDP), attention to detail, and the ability to perform and review analytical work with minimal supervision. This is an excellent opportunity to be involved in pre-formulation, formulation, analytical method development, data interpretation, troubleshooting, and continuous improvement initiatives. Key Responsibilities Perform routine and advanced analytical testing of raw materials, in-process, and finished products in compliance with GMP. Support the development of formulations (solutions, suspensions, propellant-based systems) for inhalation drug products. Operate and troubleshoot analytical instruments including HPLC, UPLC, GC, UV, and FTIR, and manage data through Empower (Waters) software. Prepare and review protocols, reports, and SOPs in alignment with quality and regulatory requirements. Ensure all documentation complies with Good Documentation Practices (GDP) and data integrity standards. Participate in method transfer, verification, and validation activities as assigned. Support investigations of OOS/OOT, deviations, and CAPA with accurate analytical input. Collaborate cross-functionally during manufacturing trials and scale-up activities. Mentor junior scientists and contribute to the team's technical development. Maintain a safe and compliant laboratory environment in accordance with EH&S and corporate policies. Qualifications PhD, MS, or BS in Analytical Chemistry, Pharmaceutics, Pharmaceutical Sciences, Biochemistry, or related discipline. Minimum 1 year of hands-on GMP laboratory experience (academic-only exposure will not be considered). Proven hands-on experience with chromatographic systems (HPLC, UPLC, GC) and analytical testing. Working knowledge of GMP/GLP, USP, ICH, and FDA regulatory expectations. Experience with Empower software for data acquisition and reporting strongly preferred. Solid understanding of GDP and deviation processes. Preferred Attributes Prior exposure to regulated audits (FDA, EMA, MHRA) is advantageous. Experience in method validation or transfer projects a plus. Strong analytical thinking, data review, and problem-solving skills. Excellent communication and teamwork abilities. High attention to detail, organization, and quality compliance. At ttg, 'We believe in making a difference One Person at a Time,' ttg OPT.

Please only W-2 candidates. Our client is looking for a Clinical Scientist who will be responsible for the following: ● Initiates and completes routine in vitro studies in an independent, efficient, and timely manner, with minimal supervision. Interprets the outcome of those experiments and proposes appropriate follow-up; troubleshoots effectively. ● Assists in the design and execution of non-routine cell-based in vitro and biochemical assays; conducts exploratory experiments with minimal supervision. ● Performs literature searches and extracts relevant information from literature and published protocols. ● Independently operates and is responsible for lab equipment; troubleshoots effectively. ● Communicates their own work effectively orally and in writing; contributes to writing protocols, procedures, and technical reports; provides input for scientific reports. ● Reports and treats data with a high level of integrity and ethics. Maintains accurate and up-to-date electronic lab notebooks. ● Complies with applicable regulations, performing all work in a safe and compliant manner; maintains proper records in accordance with Standard Operating Procedures and policies. Skills: Skills ● Experience in aseptic animal tissue culture techniques and basic molecular biology techniques including nucleic acid extraction, RT-PCR, Western Blot, ELISA, transfection is required. Experimental design, execution, and interpretation in these areas will be required. ● Proven problem-solving ability and eagerness to learn. Ability to evaluate new technologies and assist in incorporating them into our research. ● Written and verbal communication skills: concise and accurate reporting of technical data and information ● Proficiency with computers and data analysis software such as Microsoft Excel and GraphPad Prism. ● Ability and willingness to work effectively in a highly collaborative environment. Keywords: Education: Master's Degree or Bachelor's Degree with 3+ years experience in related scientific discipline; pharmaceutical, biotechnology or CRO experience is highly desirable; non-PhD applicant required. Required Skills ● ASEPTIC ANIMAL TISSUE CULTURE TECHNIQUES ● BASIC MOLECULAR BIOLOGY TECHNIQUES

Key Responsibilities: Make outbound calls to prospective patients to introduce clinical trial opportunities and conduct pre-screening assessments. Respond to inbound inquiries from patients and caregivers, providing clear, empathetic, and informative communication. Explain study requirements, benefits, and next steps in a way that builds trust and supports patient understanding. Accurately document call outcomes, patient information, and screening results in the internal database. Collaborate with clinical sites and internal teams to align outreach efforts with study timelines and eligibility criteria. Meet or exceed daily and weekly outreach and enrollment targets while maintaining high-quality interactions Use scripts and protocols to ensure consistency and compliance in patient communications. Escalate complex cases or questions to clinical staff or management as needed. Follow all HIPAA, GCP, and regulatory standards to protect patient privacy and maintain compliance. Contribute to ongoing improvement by providing feedback on call trends, patient concerns, and outreach effectiveness. Represent client professionally in every interaction, promoting trust and positive engagement with diverse patient populations. Work Schedule: Monday - Friday, 10:30 AM - 7:00 PM Location: In-office Monday - Thursday; work-from-home Fridays after training completion Language Requirement: Bilingual in English and Spanish Preferred Qualifications: Prior experience in a call center, or customer serviced based role Excellent verbal communication, listening, and interpersonal skills Comfort working in a high-volume phone-based environment Strong attention to detail and accurate data entry skills Empathy, patience, and the ability to work with individuals from various backgrounds

Lead Clinical Research Coordinator Opportunity in Miami, FL (33155) The Clinical Research Coordinator plays an integral role in supporting the day-to-day operations of clinical trials at the investigator site. This position is responsible for planning, coordinating, and executing clinical studies in compliance with study protocols, contracted scope of work, ICH/GCP guidelines, sponsor and CRO requirements, and applicable local regulations. Duties/Responsibilities Coordinate study startup activities, including site selection visits, source documentation setup, recruitment planning, and site preparation. Lead weekly site meetings and collaborate with site leadership to address facility and operational needs. Manage investigator signature processes and support subject recruitment, enrollment, and contingency planning. Monitor and track screening, enrollment, and study milestones, identifying barriers and implementing solutions. Partner with recruitment teams to improve enrollment for difficult-to-fill studies. Ensure timely and accurate data entry in EDC and clinical trial management systems, addressing discrepancies as needed. Participate in study initiation, monitoring, and close-out visits, including reviewing monitor reports and following up on action items. Conduct quality checks on subject visits and collaborate with compliance teams to address issues. Work with source documentation staff to ensure readiness for patient visits. Provide training, mentorship, and troubleshooting support to site staff; assist with onboarding new employees and evaluating training progress. Act as a liaison between site operations, financial teams, and leadership to improve workflows and communication. Develop and maintain strong investigator and sponsor relationships while providing progress updates. Participate in staff evaluations, candidate interviews, and employee development activities. Deliver presentations at training events and contribute to external collaborations for specialized study protocols. Support SOP development, special projects, business development initiatives, and team-building activities. Perform other duties as assigned. Required Skills/Abilities Strong knowledge of medical terminology, ICH/GCP, and regulatory requirements. Excellent interpersonal, communication, and organizational skills. Proficiency with Microsoft Office, including Excel. Bilingual in English and Spanish, with strong written and verbal skills. Ability to work independently and collaboratively within a team. Strong problem-solving skills with the ability to maintain confidentiality and build effective working relationships. Education/Experience Bachelor's Degree Required Certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred, or willingness to obtain within 6 months of hire. Minimum 5 years of clinical research coordinator experience, preferably with industry-sponsored trials. Additional Details Location: Miami, FL (33155) Position: Lead Clinical Research Coordinator Employment/Length of Assignment: Contracted position with the potential to be brought on permanent Hours: Monday-Friday; 8:30AM-5PM; Onsite 5 Days a Week Pay Range: $72,000-$95,000 Annual Salary (Dependent on background and years of experience) Requirements: 5+ Years of Clinical Research Coordinating Experience; Bachelor's Degree Required

The Clinical Research Coordinator is responsible for coordinating and overseeing all aspects of participant care and study execution from screening through study closeout. This role ensures compliance with study protocols, Good Clinical Practice (GCP), and federal regulations while prioritizing participant safety, data integrity, and high-quality patient care. Key Responsibilities Coordinate all aspects of participant care from screening through study completion in accordance with the study protocol and Principal Investigator (PI) delegation. Ensure the informed consent process is conducted and documented in compliance with federal regulations (45 CFR Part 46). Maintain accurate and up-to-date source documentation, including medical history collection, eligibility assessments, and documentation of all study-related procedures. Promptly identify, document, and report adverse events, protocol deviations, and unanticipated problems to the PI, sponsor, and IRB in accordance with 21 CFR Part 312. Provide individualized, protocol-based education to study participants regarding informed consent, study requirements, investigational product (IP) use, safety considerations, potential side effects, and participant rights. Facilitate timely and accurate communication of participant information with the PI and research team to support study conduct and patient safety. Maintain strict adherence to HIPAA regulations and protect participant confidentiality at all times. Dispense, administer, and educate participants on the proper use of investigational products in accordance with the protocol, scope of practice, and PI direction. Collaborate closely with the clinical team and external clinical partners to support trial implementation and ensure protocol compliance. Perform accurate and timely data collection, source documentation, and data entry into sponsor Case Report Forms (CRFs), Interactive Web Response Systems (IWRS), and databases. Resolve data queries and sponsor requests promptly. Assist with long-term storage and maintenance of research records in accordance with contractual and regulatory requirements. Prepare for and participate in site initiation visits, monitoring visits, audits, and regulatory inspections. Maintain Essential Documents and the Trial Master File (TMF), ensuring regulatory compliance and audit readiness, including FDA Form 1572, financial disclosures, IRB documentation, delegation of authority logs, monitoring reports, and enrollment logs. Support coordination with internal and external stakeholders, including sponsors and CROs, to facilitate study start-up, patient recruitment, enrollment goals, and trial execution. Promote a patient-centered research culture that emphasizes safety, quality, and ethical conduct. Manage participant stipend payments, including system registration and ongoing payment processing in accordance with company policies. Adhere to company research quality assurance standards and operating procedures. Travel as required to investigator meetings, sponsor meetings, and between facilities or practices within the community. Maintain current knowledge of clinical research regulations and standards, including GCP, FDA regulations, HIPAA, and IATA shipping requirements, and maintain required licensures and certifications. Provide training and oversight to Clinical Research Coordinators and/or Research Assistants as assigned. Actively promote GUEST customer service standards and foster effective working relationships across all levels of the organization. Participate in team initiatives, staff meetings, and perform duties in accordance with company policies and procedures. Maintain regular and reliable attendance.

I'm working with a university, ranked in the top 100 of National Universities, to hire a Clinical Research Coordinator to their drug studies team. Contract Duration: 3 month contract with high potential to convert Pay Rate: $28-34/hr About this role: Coordinate recruitment and enrollment of research participants Establish and maintain databases of subjects Schedule and conduct study visits Collect and enter data; register subjects and study visits in OnCore Perform Epic research billing review Maintain an up to date regulatory binder Schedule and attend sponsor visits and prepare and submit IRB paperwork to ensure compliance with IRB regulations. Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience Experience with drug studies is nice to have Knowledge of FDA, IRB, Pennsylvania and related regulations Prior experience with IRB submissions both local and central is nice to have Prior Electronic Data Capture (eDC) data entry skills is nice to have Strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants Interested? Apply now!

Clinical Research Coordinator Opportunity in Chicago, IL (60641) Medix is currently seeking experienced Research Professionals wanting to grow their career in the Clinical Research Field. If you are interested in an opportunity to utilize your knowledge and skill set in the field as well as continue to learn research, apply below! Job Description Coordinates all aspects of the study including recruitment, consent, screening, scheduling, tracking and provides study updates to study participants throughout the conduct of the study May collect and enter data into study case report forms and/or electronic data capture system and respond to queries in a timely manner. Submits or partners with a regulatory coordinator to submit study related documents, study protocols and study protocol amendments to the IRB per policy and procedure Ensures procedural documentation is accurate, complete, and in compliance with institutional, local, state and federal guidelines and regulations related to clinical research. May collect, process and ship potentially biohazardous specimens May administer more complex structured tests and questionnaires according to research study protocols. May utilize study-related technology and equipment as part of assessment procedures. Provide ongoing study status updates, responds to questions and may create summary report(s) for distribution to PI, Administrator, Office of Research Affairs, Sponsor and Compliance throughout the conduct of the study Organize and participate in auditing and monitoring visits Requirements: Bachelor's/Associate's degree or equivalent experience 2+ years of experience as a Clinical Research Coordinator Ideally looking for Oncology Experience Details: Location: Chicago, IL (60641) Pay: $63K-$75K (Dependent on background and years of experience) Hours: Monday - Friday; Normal Business Hours; Onsite 5 Days a Week Duration: ~6 month (1,040 Hours) contracted probationary period into direct hire / permanent position

** Seeking a Clinical Research Coordinator in Las Vegas, Neveda** Reports To: Senior Clinical Research Site Manager Department: Clinical Research Operations Employment Type: Full-time, onsite, 40 hrs a week Position Overview The Clinical Research Coordinator (CRC) plays a key role in the successful execution of clinical research studies by supporting investigators and ensuring studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), and applicable regulatory guidelines. This position involves direct participant interaction, study coordination, and accurate documentation throughout all phases of clinical trials. Key Responsibilities -Collaborate closely with Principal Investigators to coordinate all aspects of assigned clinical studies, including participant recruitment, eligibility assessment, scheduling, treatment coordination, and study-related procedures. -Perform clinical and study-related procedures, including phlebotomy, vital signs collection, centrifuge operation, ECG administration, and other protocol-required tasks. -Utilize Microsoft Office and electronic research systems efficiently, including source documentation platforms, IXRS/IWRS, and Electronic Data Capture (EDC) systems such as Medidata, Veeva, and Inform. - Monitor participant health status throughout the study and promptly communicate relevant findings to the Principal Investigator. -Identify, document, and report Serious Adverse Events (SAEs) and other safety concerns to investigators and sponsors in accordance with protocol and regulatory requirements. -Coordinate the collection, processing, packaging, and shipment of biological specimens to designated central laboratories, ensuring accuracy and compliance with laboratory and shipping guidelines. -Maintain accurate, complete, and organized study documentation in compliance with GCP and regulatory standards. Qualifications -Minimum of 3 years of hands-on experience as a Clinical Research Coordinator, preferably in Phase II-IV pharmaceutical clinical trials. -Bachelor's degree in a scientific, healthcare, or related field. -Strong attention to detail with the ability to maintain accurate and well-organized research records. -Excellent written and verbal communication skills, with the ability to interact professionally with investigators, sponsors, participants, and study team members. -Working knowledge of ethical principles, regulatory requirements, and GCP guidelines governing clinical research. -Ability to recognize potential risks, protocol deviations, and adverse events and respond promptly and appropriately.

Participant Management: Screens potential participants, explains study details, obtains informed consent, schedules visits, and acts as a primary contact for subjects. Administrative Oversight: Organizes study files, prepares and submits regulatory documents (like IRB submissions), manages study budgets, and maintains trial-specific logs. Protocol Adherence: Ensures the trial follows the specific scientific protocol, protecting data integrity and participant safety. Data & Documentation: Collects, organizes, and manages research data, including case reports and drug accountability records, often working with data management teams. Staff & Resource Coordination: Trains research staff, arranges study equipment, and communicates with laboratories and investigators. Ethical Compliance: Upholds ethical standards, ensuring patient rights and well-being are prioritized throughout the study.

Job Title: Clinical Research Coordinator - Bilingual (EN/ES) Schedule: Full-time; flexible schedule with M/W/F and T/Th/Sat coverage as needed. Typical hours are 7:30 AM - 3:30 PM, with occasional early-morning study visits (as early as 4:30 AM). Overview We are seeking a dedicated Clinical Research Coordinator to support all phases of clinical trials, from patient enrollment through study closeout. In this role, you will work closely with the Principal Investigator (PI) and cross-functional research teams to ensure high-quality study execution, strong patient support, and compliance with all regulatory requirements. This position is ideal for someone who thrives in a patient-focused environment. You will primarily support one site, allowing you to develop strong and meaningful relationships with the PI, study team, and patient population. Key Responsibilities Coordinate all aspects of clinical trials, including enrollment, study conduct, and closeout activities. Perform protocol-specific research procedures and support the PI throughout study execution. Serve as a liaison between investigators, sponsors, monitors, and internal study team members. Meet or exceed enrollment goals while ensuring high-quality, accurate, and timely data entry. Maintain strict compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all regulatory requirements. Foster a patient-centered environment, especially for rare disease populations with limited sample sizes. Support studies, including occasional early morning patient visits. Nice-to-Have Skills Prior experience in a clinical research setting. Phlebotomy experience is a plus. Strong organizational and multi-tasking abilities. Excellent communication and relationship-building skills. Must be bilingual in both English and Spanish. Soft Skills & Expectations Patient-focused, empathetic approach to clinical research. Strong interpersonal skills and the ability to collaborate effectively with diverse teams. Reliable follow-through and commitment to timely communication.

Participant Management: Screening, enrolling, scheduling, and caring for trial participants, often taking vital signs or samples. Data & Documentation: Collecting, organizing, entering data into electronic systems (like EDCs), managing Trial Master Files (TMF), and preparing reports. Study Execution: Setting up labs, preparing study materials, ensuring adherence to the trial's protocol, and cleaning work areas. Compliance & Ethics: Upholding Good Clinical Practice (GCP) and regulatory standards to safeguard participants and data integrity. Communication: Serving as a liaison between participants, medical staff, sponsors, and regulatory bodies.

Fully onsite - Direct Hire - ideally 2 years of CRC experience needed prior. Job Title: Clinical Research Coordinator (CRC) The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and management of clinical research studies. This role ensures studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), institutional policies, and regulatory guidelines. The CRC works closely with investigators, study sponsors, research participants, and regulatory bodies to ensure the successful execution of clinical trials. Key Responsibilities Coordinate and manage clinical research studies from start-up through close-out Screen, recruit, and enroll study participants according to protocol criteria Obtain and document informed consent in accordance with regulatory requirements Schedule and conduct study visits, procedures, and follow-ups Collect, document, and maintain accurate study data in source documents and electronic data capture (EDC) systems Ensure compliance with study protocols, GCP, IRB requirements, and applicable regulations Prepare and maintain regulatory documents, including IRB submissions, amendments, and continuing reviews Serve as the primary point of contact for sponsors, monitors, and study participants Assist with monitoring visits, audits, and inspections Track and report adverse events and protocol deviations Maintain study supplies, investigational product accountability, and inventory Collaborate with investigators and research team members to ensure study timelines and goals are met Public - Required Skills 2 Years of CRC Experience Comfortable working in a small team setting in a fast paced environment Public - Preferred Skills Spirometry training Public - Schedule/Shift Monday-Friday 8am-5pm

Screening, enrolling, scheduling, and caring for trial participants, often taking vital signs or samples. Collecting, organizing, entering data into electronic systems, managing Trial Master Files (TMF), and preparing reports. Setting up labs, preparing study materials, ensuring adherence to the trial's protocol, and cleaning work areas. Upholding Good Clinical Practice (GCP) and regulatory standards to safeguard participants and data integrity. Serving as a liaison between participants, medical staff, sponsors, and regulatory bodies.

Coordinates with Principal Investigator to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines. Participant pre-screening, recruitment and scheduling Complete protocol and trial system training Maintenance of regulatory documents Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study. Conducting participant visits Ability to perform basic lab and clinical procedures per protocol, such as: blood specimen collection (phlebotomy), blood pressure, vitals, EKGs, centrifuge operation, storing and shipping of lab specimens, and accountability of specimens and notification of courier for specimen pick-up Entering data in the EDC and resolving all queries Updating and maintaining trial logs and participant charts

Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol. Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research. May collaborate with Research Site Leader in the study selection process. Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors. Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians. May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting. Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Qualifications Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred. Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology. SoCRA or ACRP certification preferred. OR Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.

Clinical Research Coordinator I Client: Large Healthcare Organization Duration: 1-year contract - possibility of FTE conversion MUST RESIDE IN ASHEVILLE, NC OR NEARBY Position Summary: The Research Coordinator position is responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research. Major Responsibilities: Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement” During your employment you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. Performs routine operational activities for multiple research protocols Liaise between site research personnel, industry sponsors, and Supervisor Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable Coordinates schedule of assessments from initial submission of feasibility until study closeout Reviews the study design and inclusion/exclusion criteria with physician and patient Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data Creates study specific tools for source documentation when not provided by sponsor Collects, completes, and enters data into study specific case report forms or electronic data capture systems Generates and tracks drug shipments, device shipments, and supplies as needed Ensures timely and accurate data completion Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations Communicates all protocol-related issues to appropriate study personnel or manager Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required Reviews and responds to any monitoring and auditing findings Qualifications: Bachelor's degree - Required 1+ years of relevant experience - Required Phlebotomy - Required Certified Clinical Research Coordinator - Preferred