Clinical Research Coordinator
Clinical research coordinator job in Austin, TX
The Clinical Research Coordinator conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and the site's SOPs.
Responsibilities
Duties/Responsibilities:
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and the site's SOPs
Implement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors.
Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidential information and the site's confidential information
Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and the site's SOPs.
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
Ensure staff are delegated and trained appropriately and documented
Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
Create and execute recruitment strategies defined by Clinical Research Team
Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
Understand product development life cycle and significance of protocol design including critical data points
Understand the disease process or condition under study
Collaborate with Clinical Research Team to develop Quality Control strategy for reviewing one's work on an ongoing basis and in preparation for monitor visits.
Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG,lab processing) within scope
Other duties as assigned
Qualifications
Education/Experience:
Bachelor's degree and 2 years relevant experience in the life science industry OR
Associate's degree with 4 years relevant experience in the life science industry OR
High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year Clinical Research Coordinator experience
Required Skills:
Demonstrated knowledge of medical terminology
Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Proficient ability to work in a fast-paced environment
Proficient verbal, written, and organizational skills
Proficient interpersonal and communication skills
Proficient ability to work as a team player
Proficient ability to read, write, and speak English
Proficient ability to multi-task
Proficient ability to follow written guidelines
Proficient ability to work independently, plan and prioritize with minimal guidance
Proficient ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated problem solving and strategic decision making ability.
Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
Demonstrated leadership ability
Required Physical Abilities:
Sit or stand for long periods of time
Travel locally and nationally
Communicate in person and by a telephone
Limited walking required
Limited to lifting up to 30 pounds
Senior Clinical Coordinator
Clinical research coordinator job in San Antonio, TX
/RESPONSIBILITIES
The Senior Clinical Research Coordinator leads the evaluation of research protocols and provides clinical and risk assessment expertise on research-related procedures. Assists Director in implementation of human subject research protection program. Reviews complex human subject research protocols and supports the Clinical Research Department through coordination, monitoring, and education of processes required for Research Proposals within University Health. Represents the department at multi-institutional committees and meetings, such as IRB and OHRP.
EDUCATION/EXPERIENCE
Graduation from an accredited college or university with a Bachelor's of Science in Nursing. May substitute 8 years of related experience and licensure for required education. Master's degree preferred. A minimum of three years Research experience required. Possesses or qualifies to obtain within 6 months of employment a Clinical Research Certification (i.e. CCRP or CCRA). Has a working knowledge of research methods and knowledge of federal legislation regarding human subject research is required. Expertise in applying for research protocols, budgeting, program planning and evaluation is preferred. Exercises mature judgment and discretion in any confidential or sensitive matters.
Scientist, Study Manager
Clinical research coordinator job in Austin, TX
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
The Preclinical Team is responsible for designing, conducting, documenting, analyzing, and reporting preclinical studies. Our team provides a means for ensuring the safe, effective, and robust implantation of Neuralink devices into animals and, ultimately, humans.
Job Responsibilities and Description:
The Study Manager is a staff scientist who will interact with Neuralink's technical and clinical teams, as well as senior staff, to ensure that preclinical bench, pilot, R&D, and safety studies are carried out, critical data is gathered to support regulatory filings, and methods comply with good laboratory practices (GLP), if applicable. You will compress timelines and work closely with a Study Director to compile data, handle reporting, communicate cross-functionally, establish timelines, and eliminate roadblocks that halt progress. Other job responsibilities will include:
Performing and verifying data collection
Serving as the main point of contact for assigned studies
Interacting directly with the Sponsor, SD, and other teams to:
Obtain important information for a study
Establish, monitor and compress timelines
Ensure SOPs are implemented and adhered to
Assign and confirm staff trainings are complete
Following up with key players throughout the study duration and leading key meetings
Compiling and analyzing data
Reviewing reports cross-functionally
Writing final and auxiliary scientific reports
Support study design and protocol writing
Generating deviation reports in response to QA audits
Improving our internal information process and execution, including finalizing details and documents, and generating tracked documents on our internal laboratory management system
Representing our team across company communication channels
Required Qualifications
Bachelor's degree in neuroscience, biomedical engineering, natural sciences, or a related field
Evidence of exceptional technical depth in neuroscience, biomedical engineering, or a related field
Experience working with, or a working knowledge of, medical devices
Strong understanding of the scientific method and engineering first principles
Demonstrated ability to effectively manage a project, lab, or study
Strong foundation in technical writing and data analysis
Natural capacity to communicate cross-functionally between teams and departments
Organized and independent worker
Ability to deliver high-quality results rapidly and consistently without sacrificing quality
Computer skills and proficiency in Google Docs, Sheets, Drive, and Mail
Skilled in statistical analyses and related software (e.g., Prism, R, SPSS)
Ability to travel as needed.
Preferred Qualifications:
3+ years of academic or industry experience managing research projects
Experience with or an understanding of GLP and FDA guidelines
Experience working alongside technical and operational teams
Experience working in an OR
Coding skills (e.g., SAS, R, Matlab, Python, SQL) and automated process development
Experience working with or a working knowledge of medical devices
Work Environment: Office (on site required), but could include vivarium, laboratory, and operating room
Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees' success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
Base Salary Range:$111,000-$185,000 USD
What We Offer:
Full-time employees are eligible for the following benefits listed below.
An opportunity to change the world and work with some of the smartest and most talented experts from different fields
Growth potential; we rapidly advance team members who have an outsized impact
Excellent medical, dental, and vision insurance through a PPO plan
Paid holidays
Commuter benefits
Meals provided
Equity (RSUs)
*Temporary Employees & Interns excluded
401(k) plan
*Interns initially excluded until they work 1,000 hours
Parental leave
*Temporary Employees & Interns excluded
Flexible time off
*Temporary Employees & Interns excluded
Auto-ApplyClinical Research Manager
Clinical research coordinator job in Austin, TX
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. Acts as liaison between functions (i.e. PM, investigator, research team, etc.). Ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the project leads and clients (as needed) for resolution.
Qualifications:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Knowledge of Phase 1 processes and strong knowledge of clinical study operations
Knowledge of FDA regulations and ICH GCP guidelines
Solid computer skills with working knowledge of Microsoft Office applications
Good time management and multi-tasking skills
Solid written and verbal communication skills
Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
Favorable consulting skills to act as a liaison between external and internal groups
Knowledge of budgeting/forecasting/planning projects
Auto-ApplyStudy Manager I
Clinical research coordinator job in San Antonio, TX
Job Details San Antonio, TX - San Antonio, TXStudy Manager I
A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.
DUTIES & RESPONSIBILITIES
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
Adherence and compliance to the assigned protocols at their respective site(s).
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to
Sponsor-provided and IRB-approved Protocol Training
All relevant Protocol Amendments Training
Any study-specific Manuals Training as applicable
Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.
Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.
Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.
Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.
Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
Being prepared for and available at all required company meetings.
Submitting required administrative paperwork per company timelines.
Occasionally attending out-of-town Investigator Meetings.
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
Facilitate effective communication between patients, healthcare providers, and research staff
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
Facilitate effective communication between patients, healthcare providers, and research staff
Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE
Education:
High School Diploma or equivalent required
Bachelor's degree preferred
Foreign Medical Graduates preferred
Experience:
Minimum of 5 years experience in Clinical Research
Supervisory experience preferred
Wide therapeutic range of clinical trials experience preferred
Regulatory research experience is a plus
Credentials:
ACRP or equivalent certification is preferred
Knowledge and Skills:
Goals-driven while continuously maintaining quality.
Must be detailed-oriented, proactive, and able to take initiative.
Must have strong written and communication skills.
Must have excellent customer service skills.
Proficient communication and comprehension skills both verbal and written in the English language are required.
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred
PT Study Coordinator
Clinical research coordinator job in Austin, TX
Full-time Description
The Research Coordinator specializes in developing, planning, and implementing the SerenaGroup Research Program. The research coordinator will work directly with the CRO to develop specific workflows for the assigned clinical trials and implement an organized structure, including community education, referral sources, and educational programs. The Research Coordinator will work with the Principal Investigator (PI), CRO, and sponsor(s) to support and guide the administration of each clinical study's compliance, financial, personnel, and other related aspects.
Job Type: Full-time
Pay: From $25.00 per hour
Schedule:
8-hour shift
Monday to Friday
No nights
No weekends
Work Location: Hybrid remote in Austin, TX
Requirements
Language Ability:
Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Knowledge of modern equipment and ability to maintain confidentiality and exert physical effort to maintain and distribute files.
Math Ability:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Computer Skills:
Proficient in Microsoft Office, Outlook, Excel, PowerPoint, and Word; able to navigate through internet and intranet. Ability to learn internal clinical outcome database, upload photographs from camera.
Environment Expectations:
Work Environment:
The incumbent in this position is not required to work under any extreme condition and must be able to work around a moderate noise level, such as an office environment.
Physical Demands:
The incumbent in this position typically has to stand approximately 20% of the time, walk 20% of the time, and sit 60% of the time. In addition, this person talks or hears 100% of the time.
Accountability:
The Clinical Research Coordinator is accountable for the day-to-day operations of ensuring the clinical trial program runs smoothly, including phone messages, faxes to physicians and staff, database entry, billing entry, etc.
Specific Individual Considerations:
The designation of "essential functions" and "other duties" is for purposes of compliance with the Americans with Disabilities Act. This job description should not be construed to imply that these requirements are the only duties, responsibilities, and qualifications for this position. Incumbents may be required to follow any additional related instructions, acquire related job skills, and perform other related work as required. Incumbents in this position may be required to perform all or some of the above duties and responsibilities with varying concentration levels based on the incumbents' skill level and program needs.
Research Coordinator I/II
Clinical research coordinator job in San Antonio, TX
POSITION DESCRIPTION: The Research Coordinator's primary responsibility is to work either directly with each client or as an underwriter for a Research Scientist in the design of research studies that will accomplish the client's technical, regulatory, and business objectives. The Research Coordinator will also provide basic internal quality support to the contract research department, client services, and company management on microbiological scientific matters within the coordinator's sphere of competence.
ESSENTIAL FUNCTIONS:
* Meet with clients to discuss and exchange views on study objectives.
* Lead client-facing discussions on matters germane to contract research or technical services.
* Design and draft study proposals for shelf-life studies, inoculated challenge studies, and proficiency testing.
* Deliver contract research proposals and reports in a timely manner.
* Effectively work with and collaborate on technical matters among a team of research scientists.
* Interact with clients/projects requiring multiple resources and effectively facilitate inter-company and interdepartmental initiatives and interactions to best meet the needs of the client/project.
* Participate in routine project proposal generation with attention to profitability and client satisfaction.
* Contribute to the design and development of consistent and efficient presentation and reporting of contract research results.
* Participate and comply with all regulations promoting a safe and healthy work environment.
* Develop executable protocols and training for introduction of non-routine shelf-life methods (Level II function).
* Assist in the data compilation and framing of reports for more advanced technical studies such as cooking instruction validations, method validations, and process validations
* Assist with routine departmental functions to include, but not limited to, coordinating media requests, reviewing, and releasing Certificate of Analysis, maintaining microbiological culture inventories.
* Support commercial team as a resource for basic technical inquiries from current and prospective clients as needed.
POSITION REQUIREMENTS:
* B.S. in science discipline (Food Science, Chemistry, Microbiology, Engineering, or related field).
* 0-4 years of previous contract research work experience (shelf-life, microbial challenge, and process validation) in the food industry.
* Familiarity with International Organization for Standardization (ISO) 17025 accreditation is an added benefit.
* Familiarity with FDA BAM, USDA MLG, CMMEF, APHA, and AOAC methodology.
* Adequate conceptual strength to embrace new methods, techniques, and technologies effectively.
* Excellent verbal and written communication and organization skills.
* Proficient with Microsoft Office Suite applications (MS Excel, Word).
* Experience working with LIMS systems is an added benefit.
* Relatively infrequent travel may be required to support client projects and for industry specific events and conferences.
Clinical Research Coordinator - Early Phase
Clinical research coordinator job in San Antonio, TX
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are actively hiring a Clinical Research Coordinator at our site in San Antonio! This role will support our Early Phase team, so Phase 1 clinical trial experience is ideal!
The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Monday-Friday, 8:30 AM - 5 PM
Location: 5430 Fredericksburg Rd., Suite 200, San Antonio, TX 78229
Compensation: $24-$35/hr
Benefits: Health, dental, and vision insurance plans, 401(k) with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.
RESPONSIBILITIES
The Clinical Research Coordinator (CRC) obtains study participant informed consent.
Executes study protocol procedures in a detailed, organized, and professional manner.
Performs human specimen lab draws and processing, and packages specimen shipments.
Creates and completes study source documents and adverse event reporting on an e-source system.
Maintains study-specific files and supplies.
Communicate with the Study Sponsor/CRO regarding study-specific questions.
Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits.
Additional duties as assigned by management
QUALIFICATIONS
Bachelor's degree preferred, but not required
Phlebotomy experience is required; EKG or other patient labs/processes preferred
Preferably 1+ year of experience as a Clinical Research Coordinator
Must have Phase 1 clinical trial experience
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
Auto-ApplyResearch Coordinator
Clinical research coordinator job in San Antonio, TX
Minimum Qualifications:
The Research Coordinator must be knowledgeable of standard research and oncology care practices. The Research Coordinator advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care.
Current BLS
Current Texas Registered Nursing License for RNs
Bachelor's degree required for non-RNs
Oncology clinical trial experience preferred
Research Coordination experience preferred
Essential Duties and Responsibilities:
Essential and other important responsibilities and duties may include but are not limited to the following:
Protocol Compliance
Identifies primary and secondary study objectives and outcome measures.
Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research
Complies with NEXT Oncology SOPs
Participates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timeliness of protocol-related procedures
Collaborates with the PI, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs
Provides protocol specific education to clinical staff
Facilitates and participates in the preparation for and conduct of meetings/teleconferences with sponsors, monitors, and auditors.
Provides timely, accurate, and complete reporting of serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the IRB and sponsor
Contributes to the development of corrective and preventive action plans for unanticipated problems, deviations, violations, and issues of noncompliance
Informed Consent
Identifies and intervenes to address barriers to effective informed consent discussions and decision making (e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception)
Describes and abides by institutional policy and processes for informed consent
Ensures that the most current version of the IRB approved protocol consent document is used by the physician investigator when consenting or re-consenting a patient
Collaborates with the physician investigator to ensure initial and ongoing consent process is performed and documented
Assesses ongoing consent through discussions with patients and reinforcement of education
Assesses patient's understanding of the information provided during the informed consent process
Ensures timely re-consenting as needed by the physician investigator
Demonstrates understanding of tiered consent process when optional correlative studies (e.g., biospecimen, quality of life, patient-reported outcomes collections) are involved
Confirms informed consent is obtained prior to performing any study specific tasks
Management of Clinical Trial Patients
Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol
Educates the patient and family regarding protocol participation
Provides patient education regarding required study procedures
If the Research Coordinator is a Registered Nurse, educates the patient and family regarding clinical condition, and/or disease process. If the Research Coordinator is not a RN, he/she will schedule educational time with a RN
If the Research Coordinator is a Registered Nurse, identifies patients who require increased nursing assessment and management in addition to the clinical trial requirements and collaborate with other members of the healthcare team to ensure patient safety. If the Research Coordinator is not a RN, he/she will schedule educational time with a RN.
Coordinates, schedules, and ensures timely completion of protocol-required events and other requirements (e.g., pharmacokinetics or -dynamics, scans, study visits, QOL,)
Assesses individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implement interventions as necessary
Evaluates patient's adherence to and documentation of self-administered protocol agents and the return of such agents
Collaborates with the investigator to determine disease response as defined by the protocol and communicates findings to the study team and other care providers
Evaluates patient's adherence to and documentation of self-administered protocol agents and return of such agents
Collaborates with the investigator to determine if any treatment schedule or drug dose modification is necessary and communicates findings to the study team and other care providers
Ensures appropriate communication between research and clinical staff related to patient-specific care needs
Ensures evidence-based symptom management as permitted by the protocol
Documentation and Document Management
Documents all patient encounters in the legal medical record per licensure and institutional requirements
Obtains documents from outside providers or laboratories that are needed as part of the research data
Educates other research team members and clinical staff regarding appropriate and accurate source documentation for patients in clinical trials
Assesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents
Maintains the privacy and confidentiality of patients' source documents
Maintains specified study documents in the Research Coordinator files
Participates in the development of approved source documents, templates, or forms
Data Management and Information Technology
Adheres to the data management plan per NEXT SOPs and sponsor data management plan
Assists in troubleshooting data entry issues
Ensures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate manner
Ensures that data recorded on the CRFs can be verified within the source documents.
Participates in quality control activities to ensure data integrity, including timely responses to database or sponsor queries
Enters data into electronic data capture for SAEs as appropriate
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination.
Requires standing and walking for extensive periods of time.
Occasionally lifts and carries items weighing up to 40 lbs.
Requires corrected vision and hearing to normal range
Supervision
The Research Coordinator reports to the VP of Clinical Operations.
Clinical Research Associate I
Clinical research coordinator job in Austin, TX
Job Posting Title: Clinical Research Associate I * --- Hiring Department: Department of Psychiatry * --- All Applicants * --- Weekly Scheduled Hours: 40 * --- FLSA Status: Exempt * --- * --- Expected to Continue Until Aug 31, 2026
* ---
Location:
AUSTIN, TX
* ---
Job Details:
General Notes
This is a grant funded position with an end date of 8/31/2026, renewable based upon availability of funding, work performance, and progress toward research goals.
Purpose
The Clinical Research Associate I (CRA I) is responsible for assisting in the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and study protocols. Key responsibilities include site management, data collection, and ensuring the integrity of clinical data.
The Clinical Research Associate I will perform independently or with general direction at the fully operational journey level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, the University of Texas at Austin and regulating agency policies.
A successful candidate will possess all of the following knowledge, skill and abilities: attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; the ability to multi-task in a fast-paced environment while working with a diverse subject population; ability to work well independently, ability to complete projects in a timely manner, and ability to prioritize multiple projects to ensure the completion of essential tasks by deadlines; excellent organizational skills; and excellent interpersonal skills to work effectively in a team.
Responsibilities
Site Management
* Conduct site initiation, monitoring, and close-out visits while managing participant recruitment, screening, and enrollment to ensure protocol adherence, regulatory compliance, and successful study execution.
* Ensures compliance with study protocols and regulatory requirements.
* Manages site performance and resolves issues.
* Administers questionnaires, collect medical history, and perform study procedures.
* Maintains rapport with participants to ensure retention and address concerns.
* Obtains informed consent and ensure participant safety throughout protocol procedures.
* Coordinates with affiliated departments and external collaborators.
Data Collection and Management
* Collects and verifies data from clinical sites.
* Ensures accurate and timely data entry into electronic data capture systems (e.g. REDCap).
* Reviews and resolves data queries.
* Assists with manuscript and grant preparation, including opportunities for authorship.
* Maintains and updates study databases and data collection forms.
Regulatory Compliance
* Ensures adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
* Facilitate institutional review board (IRB) applications, submissions, and updates across multiple sites.
* Prepares and maintains regulatory documents.
* Coordinates with ethics committees to safeguard participant rights.
* Participate in internal and external audits and protocol reviews.
Participant Recruitment and Retention
* Evaluates medical records and performs screenings to identify eligible study participants.
* Assists in screening and enrolling study participants.
* Maintains communication with participants to ensure retention.
* Addresses participant concerns and queries.
Reporting and Documentation
* Prepares study reports and documentation.
* Maintains accurate records of study activities.
* Assists in the preparation of manuscripts and publications.
Marginal or Periodic Functions
* Conducts literature reviews to support study design and protocol development.
* Assists in the training of new site staff and research team members.
* Participates in internal and external audits.
* Supports the development of study protocols and case report forms.
* Attends conferences and workshops to stay updated on industry trends.
* Adheres to internal controls and reporting structure.
* Performs related duties as required.
Knowledge/Skills/Abilities
* Double-checks work for errors, maintains organized records, and follows detailed procedures.
* Writes clear and concise reports, actively listens to others, and presents information effectively.
* Analyzes information, develops solutions, and implements corrective actions.
* Shares information, supports team decisions, and contributes to team success.
* Prioritizes tasks, sets realistic deadlines, and uses time efficiently.
Required Qualifications
* Requires a Bachelor's Degree in life sciences, nursing, or a related field.
* 1 year of relevant clinical research experience.
* Familiarity with IRB processes and human subjects protection standards.
* Experience with electronic data capture systems (e.g., REDCap).
* Relevant education and experience may be substituted as appropriate
Preferred Qualifications
* Master's Degree in life sciences, nursing, or a related field. with at least 2 year(s) of experience in
* Clinical research experience preferably involving pediatric or neurodevelopmental populations.
* Experience with statistical software (e.g., R, SAS, SPSS).
* Prior experience presenting research findings or contributing to publications.
* Completion of Human Subjects Protection Training.
* Experience working with children and families affected by neurodevelopmental disorders.
* Strong written and verbal communication skills.
* Ability to abstract data from medical records and manage complex databases.
* Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP)
Salary Range
$40,000 + depending on qualifications
Working Conditions
* May work around standard office conditions
* Repetitive use of a keyboard at a workstation
* Occasional weekend, overtime, and evening work to meet deadlines
* Occasional interstate, intrastate, and international travel
* This position is 100% on-campus, with an expectation to report to work on-site during the scheduled work week. Employees are expected to adhere to all applicable university health and safety protocols.
Required Materials
* Resume/CV
* 3 work references with their contact information; at least one reference should be from a supervisor
* Letter of interest
Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.
Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.
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Employment Eligibility:
Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.
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Retirement Plan Eligibility:
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.
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Background Checks:
A criminal history background check will be required for finalist(s) under consideration for this position.
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Equal Opportunity Employer:
The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.
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Pay Transparency:
The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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Employment Eligibility Verification:
If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.
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E-Verify:
The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university's company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:
* E-Verify Poster (English and Spanish) [PDF]
* Right to Work Poster (English) [PDF]
* Right to Work Poster (Spanish) [PDF]
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Compliance:
Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.
The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.
UX Research Coordinator/Lead
Clinical research coordinator job in Austin, TX
ACS delivers information technology solutions, staffing and workforce management services to global Fortune 1000 companies, across various industry vertical marketplaces. In just over a decade, ACS has grown to over $500 Million in sales revenue, 6500 employees working on a global basis for over half of the Fortune 125. visit our web ************************
A UX (User Experience) Research Recruiting Coordinator will work closely with the UX researchers to plan, recruit, and schedule potential research participants for a wide range of UX studies. The coordinator will be responsible for the recruitment of research participants for multiple projects that encompass a wide variety of products and services. The coordinator will be supporting multiple researchers at once recruiting potential research participants to ensure the success of their studies. Creative problem solving and lead generations are essential for being successful in this role.
The coordinator will need to be familiar with Mac OS, Google Suite, and must be able to work with large datasets in spreadsheets. A successful research recruiting coordinator will be organized, detail-oriented with good time-management skills, and able to maintain professional and friendly participant and researcher relationships. Outstanding written and verbal communication skills are required, as the coordinator will be in constant communication with both participants and researchers.
Your responsibilities will include but are not limited to:
Source, screen and recruit research participants for UX studies
Partner and collaborate with UX researchers to identify key participant requirements
Curate participants to ensure a high quality sample pool for the researchers
Manage calendars, timelines, scheduling details, and logistics for multiple UX studies
Track and analyze participant activity and document in our database
Network with potential participants to generate new leads
Qualifications
Basic Qualifications
High School Diploma or GED Equivalent
At least 1 year of experience relating to the job description
Preferred
Experience in customer support, data entry, research and/or research recruiting for a technology company
Problem solving abilities
Bachelor's degree
Ability to work with large data sets in spreadsheets
Professional written and verbal communication
Analytical skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Clinical Research Coordinator
Clinical research coordinator job in Round Rock, TX
Central Texas Neurology Consultants is seeking an experienced Clinical Research Coordinator (CRC) to manage Neurology studies. Responsibilities include, but are not limited to EDC data entry, scheduling, chart preparation, conducting rating scales, collecting vital signs, blood draws, and ECGs.
Key duties include but not limited to:
Responsible for the integrity and overall quality of assigned clinical research trials
Serves as the primary contact for study subjects and sponsors, communicating daily as needed.
Reviews study protocols and brochures; creates study document binder and prepares source documents including study and subject information folders.
Attend sponsor meeting as needed for assigned protocols.
Oversee sponsor database process.
Completes study procedures including:
Pre-screening, screening, and study visits in conjunction with Physician/Investigator (may include vital signs, performing EKG's, phlebotomy, processing specimens and shipping to labs).
Documentation of patient progress in response to investigative agents.
Coordination of monitor visits with patients.
Completion of source documents and case report forms.
Oversee preparation of physician orders to ensure protocol compliance as needed.
Maintain communication with physician regarding study requirements, dose modifications, and adverse events.
Upkeeps all trial regulator documentation.
Maintain high level of understanding of the ICH/GCP guidelines.
Perform other related duties as assigned
Qualifications
A minimum of 2 year's relevant work experience as a Clinical Research Coordinator.
This person must be highly detailed oriented, possess stellar organizational and prioritization skills, have excellent verbal and written communication and can work in a fast paced environment under limited supervision.
Skilled with Electronic Medical Record (EMR
Preferred:
At least 2 years of experience as a Clinical Research Coordinator or similar role; Neurology experience a strong plus. CCRC certified a strong plus
Prior working knowledge of research methodology, medical terminology and pharmacology.)
What We Offer
Full Time, 40 hour, Monday to Friday work week.
Competitive Salary with generous paid time off.
Medical, Dental, and Vision Insurance
Auto-ApplyClinical Research Coordinator San Antonio
Clinical research coordinator job in San Antonio, TX
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
Adheres to the USRC Research quality assurance program guidelines.
Travel to Investigator Meetings or similar research related meetings is required.
Travel may be required between dialysis facilities or nephrology practices within the community.
Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
Participate in staff meetings as required.
Regular and reliable attendance is required for the job.
Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
Regular and reliable attendance is required for the job.
Clinical Research Coordinator
Clinical research coordinator job in Austin, TX
Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery! Summary: PCR seeks a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager. Duties and Responsibilities: Clinical Trial Execution:
Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations
Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment
Create and complete study related documents and new study preparation
Function as a liaison with pharmaceutical sponsors and external vendors
Prepare for study monitor visits (onsite or remote), audit inspections, etc.
Respond to internal and external requests for information in a timely manner
Perform subject screening and recruitment
Contribute to data management for research projects
Identify opportunities to improve patient care and satisfaction
Conduct patient-facing encounters with compassion, empathy, and thoroughness
Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects
Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose
Obtains and documents adverse event data on appropriate forms
Ensure source documents are transcribed to EDC platform per protocol on a timely manner
Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team
Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team
Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients
Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume
Attends the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate
Administration:
Ensure that electronic case report forms are completed
Create memos, emails, and letters related to study activities
Create and maintain reports and/or spreadsheets as requested
Ensure that all patient data is entered into the clinical trial management system in a timely manner
Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections
Responsible for reporting safety information to all regulatory agencies
Understand the aspects of Regulatory and IRB requirements for studies
Performs quality checks on source documents specific to the study
Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Education / Experience:
Highschool diploma or general education degree (GED) required
Bachelor's Degree in scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from Research Assistant role
Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS
Must have strong knowledge of ICH/GCP guidelines
Must complete CITI training before interacting with participants and must re-certify every 3 years
Must be trained and certified in administration of Fibroscan, training provided during onboarding
Must have basic life support (BLS) training, provided during onboarding
Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time
Strong written and oral communication skills
Knowledge of basic medical terminology
Possess impeccable integrity and personal and professional values that are consistent with PCR's high standards and mission
Comply with the company policies, code of ethics, and guiding values always
Proficient in Spanish and English preferred
Certificates and Licenses:
Valid driver's license and insurance
Knowledge, Skills, and Other Abilities:
Must be able to effectively communicate with all levels of internal and external contacts
Ability to work independently and multi-task in a fast-paced team environment
Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment
Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients
Must be able to work independently and collaborate with a team
Ability to interpret clinical research protocols
Strong problem-solving and decision-making skills, particularly when under pressure
Proactive at identifying, addressing, and solving issues in real time
Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment
Work Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Work is performed in an office/laboratory and/or a clinical environment.
Exposure to biological fluids and/or bloodborne pathogens.
Personal protective equipment required such as protective eyewear, garments, and gloves.
Occasional travel may be required domestic and/or international.
Ability to work in an upright and/or stationary position for 6-10 hours per day.
Frequent mobility required.
Occasionally squatting, kneeling, or bending.
Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.
Benefits of working at Pinnacle Clinical Research:
401k
Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
3 weeks of paid time off
14 paid company holidays
Scrub uniform voucher (specific positions apply)
And more!
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
Clinical Research Coordinator RN
Clinical research coordinator job in San Antonio, TX
Responsible for managing all aspects of clinical trial coordination in a fast-paced oncology clinic. This role involves patient screening, enrollment, and ongoing support throughout the trial process while ensuring strict compliance with protocols and regulatory standards.
Key Responsibilities:
- Manage patient screening, enrollment, and maintenance for clinical trials across multiple tumor types (e.g., breast cancer, colorectal).
- Ensure protocol compliance and handle informed consent processes.
- Monitor patient conditions and document accurate data in electronic systems.
- Identify, qualify, and track patients for clinical trials.
- Maintain quality standards by adhering to regulations and research guidelines.
- Collaborate closely with physicians and providers to assist patients through trial progression.
- Train staff on trial procedures and maintain understanding of research program goals.
- May assist with budget oversight and resource allocation.
- Utilize computer systems extensively for data entry and reporting.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: ****************************************************
Skills and Requirements
· 1-3 years of RN experience in EITHER Oncology or Clinical Research
· TX RN license
· Personality: Organized and experienced team player with strong people skills, able to work well with diverse personalities and communicate confidently with physician BSN in nursing Any research certifications OCN, SoCRA, or ACRP certifications
Tax & Compliance Research Specialist
Clinical research coordinator job in San Antonio, TX
Job Description
About Us
Catalyst Labs is a leading talent agency specializing in Tax, Tax Technology and Transfer Pricing. We stand out as an agency that is deeply embedded in our clients recruitment operations. We work directly with hiring managers such as Partners and Directors of Big 4/ Big 6 and Big 20, in-house Tax leaders such as CFOs and Head of Tax and startup founders in the Tax Tech ecosystem, who understand the value of strategic tax leadership, and we take pride in facilitating conversations that are aligned with your expertise and long-term goals.
Our Client:
A fast-growing technology company reshaping digital vehicle commerce based in New York that raised $17m in Funding. Their lightning-fast checkout platform has already driven tens of millions in revenue for over 20 major automotive partners who rely on their technology to power online sales. They support a diverse mix of publicly traded enterprises generating billions in annual GMV, rapidly scaling new entrants backed by significant venture funding, and an extensive network of dealerships.
Location: New York
Work type: Full time, Hybrid (In-person 4 days/week in NY)
Overview
The Tax & Compliance Research Specialist will be responsible for establishing and maintaining a comprehensive sales and use tax system for vehicle sales across all U.S. states. The role includes conducting tax research, managing compliance processes, and ensuring accurate reporting and remission. After establishing the tax framework, this position will support wider operational research projects, including DMV compliance and other regulatory initiatives, helping to build a strong compliance framework for the organization.
Key Responsibilities
Conduct ongoing research on sales and use tax requirements for vehicle sales across all 50 U.S. states.
Develop, document, and manage full tax reporting and remission workflows.
Assist with audits, reconciliations, and continuous process improvements.
Keep thorough records to support filings, compliance checks, and future reviews.
Contribute to broader operational research, including DMV regulations, compliance initiatives, and other regulatory topics.
Qualifications Required
Minimum 2 years of experience in tax compliance, tax accounting, or a similar field.
Strong understanding of multi-state Sales and Use Tax processes and remission.
Ability to research and interpret state tax statutes, rules, and regulatory requirements.
Experience using tax technology platforms; Vertex experience is a major plus.
Willingness to take initiative on non-tax projects, including DMV and regulatory research.
Based in (or open to relocating to) New York City.
Qualifications Preferred
Background in automotive or vehicle-related tax compliance.
Excellent communication skills with the ability to collaborate across finance, operations, and external teams.
Proven ability to work independently in a fast-paced startup environment.
Note:
We adhere to strict data protection policies to ensure that your information is secure and only shared with potential employers with your explicit consent to ensure your confidentiality throughout the hiring process
UX Research Coordinator/Lead
Clinical research coordinator job in Austin, TX
ACS delivers information technology solutions, staffing and workforce management services to global Fortune 1000 companies, across various industry vertical marketplaces. In just over a decade, ACS has grown to over $500 Million in sales revenue, 6500 employees working on a global basis for over half of the Fortune 125. visit our web ************************
A UX (User Experience) Research Recruiting Coordinator will work closely with the UX researchers to plan, recruit, and schedule potential research participants for a wide range of UX studies. The coordinator will be responsible for the recruitment of research participants for multiple projects that encompass a wide variety of products and services. The coordinator will be supporting multiple researchers at once recruiting potential research participants to ensure the success of their studies. Creative problem solving and lead generations are essential for being successful in this role.
The coordinator will need to be familiar with Mac OS, Google Suite, and must be able to work with large datasets in spreadsheets. A successful research recruiting coordinator will be organized, detail-oriented with good time-management skills, and able to maintain professional and friendly participant and researcher relationships. Outstanding written and verbal communication skills are required, as the coordinator will be in constant communication with both participants and researchers.
Your responsibilities will include but are not limited to:
Source, screen and recruit research participants for UX studies
Partner and collaborate with UX researchers to identify key participant requirements
Curate participants to ensure a high quality sample pool for the researchers
Manage calendars, timelines, scheduling details, and logistics for multiple UX studies
Track and analyze participant activity and document in our database
Network with potential participants to generate new leads
Qualifications
Basic Qualifications
High School Diploma or GED Equivalent
At least 1 year of experience relating to the job description
Preferred
Experience in customer support, data entry, research and/or research recruiting for a technology company
Problem solving abilities
Bachelor's degree
Ability to work with large data sets in spreadsheets
Professional written and verbal communication
Analytical skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Clinical Research Coordinator
Clinical research coordinator job in San Antonio, TX
Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery! Summary: PCR seeks a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager. Duties and Responsibilities: Clinical Trial Execution:
Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations
Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment
Create and complete study related documents and new study preparation
Function as a liaison with pharmaceutical sponsors and external vendors
Prepare for study monitor visits (onsite or remote), audit inspections, etc.
Respond to internal and external requests for information in a timely manner
Perform subject screening and recruitment
Contribute to data management for research projects
Identify opportunities to improve patient care and satisfaction
Conduct patient-facing encounters with compassion, empathy, and thoroughness
Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects
Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose
Obtains and documents adverse event data on appropriate forms
Ensure source documents are transcribed to EDC platform per protocol on a timely manner
Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team
Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team
Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients
Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume
Attends the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate
Administration:
Ensure that electronic case report forms are completed
Create memos, emails, and letters related to study activities
Create and maintain reports and/or spreadsheets as requested
Ensure that all patient data is entered into the clinical trial management system in a timely manner
Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections
Responsible for reporting safety information to all regulatory agencies
Understand the aspects of Regulatory and IRB requirements for studies
Performs quality checks on source documents specific to the study
Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.
Education / Experience:
Highschool diploma or general education degree (GED) required
Bachelor's Degree in scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from Research Assistant role
Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS
Must have strong knowledge of ICH/GCP guidelines
Must complete CITI training before interacting with participants and must re-certify every 3 years
Must be trained and certified in administration of Fibroscan, training provided during onboarding
Must have basic life support (BLS) training, provided during onboarding
Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time
Strong written and oral communication skills
Knowledge of basic medical terminology
Possess impeccable integrity and personal and professional values that are consistent with PCR's high standards and mission
Comply with the company policies, code of ethics, and guiding values always
Proficient in Spanish and English preferred
Certificates and Licenses:
Valid driver's license and insurance
Knowledge, Skills, and Other Abilities:
Must be able to effectively communicate with all levels of internal and external contacts
Ability to work independently and multi-task in a fast-paced team environment
Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment
Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients
Must be able to work independently and collaborate with a team
Ability to interpret clinical research protocols
Strong problem-solving and decision-making skills, particularly when under pressure
Proactive at identifying, addressing, and solving issues in real time
Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment
Work Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Work is performed in an office/laboratory and/or a clinical environment.
Exposure to biological fluids and/or bloodborne pathogens.
Personal protective equipment required such as protective eyewear, garments, and gloves.
Occasional travel may be required domestic and/or international.
Ability to work in an upright and/or stationary position for 6-10 hours per day.
Frequent mobility required.
Occasionally squatting, kneeling, or bending.
Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.
Benefits of working at Pinnacle Clinical Research:
401k
Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
3 weeks of paid time off
14 paid company holidays
Scrub uniform voucher (specific positions apply)
And more!
Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.
Clinical Research Coordinator I
Clinical research coordinator job in San Antonio, TX
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are actively hiring Clinical Research Coordinators at our site in San Antonio! Clearly defined career development pathway into CRC II, Sr CRC, and even Team Lead opportunities.
The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Monday-Friday, 8 AM - 5:30 PM
Compensation: $24-$26/hr
Benefits: Health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays.
RESPONSIBILITIES
The Clinical Research Coordinator (CRC) obtains study participant informed consent.
Executes study protocol procedures in a detailed, organized, and professional manner.
Performs human specimen lab draws and processing, and packages specimen shipments.
Creates and completes study source documents and adverse event reporting on an e-source system.
Maintains study-specific files and supplies.
Communicate with the Study Sponsor/CRO regarding study-specific questions.
Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits.
Additional responsibilities as assigned by management.
QUALIFICATIONS
Bachelor's degree preferred, but not required
Phlebotomy experience is required; EKG or other patient labs/processes preferred
Preferably 1+ year of experience as a Clinical Research Coordinator
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
Auto-ApplySenior Clinical Coordinator
Clinical research coordinator job in San Antonio, TX
Senior Clinical Research Coordinator
Full-Time - Day Shift
Advance the Future of Clinical Research
Are you passionate about clinical research and ready to take your expertise to the next level? At University Health, we're seeking a Senior Clinical Research Coordinator to lead and support high-impact studies that shape the future of patient care. This is a unique opportunity to bring your clinical insight and research experience to a role that supports innovation, compliance, and excellence in human subject research.
What You'll Do
As a Senior Clinical Research Coordinator, you'll play a vital leadership role in the coordination and review of complex human subject research protocols. You will:
Evaluate and provide expert clinical and risk assessment on research protocols and procedures
Assist the Director with implementing a robust Human Subjects Protection Program
Serve as a departmental representative to internal and external research committees, including IRB and OHRP
Coordinate, monitor, and educate staff on best practices in research compliance and study execution
Support grant applications, budgeting, and program planning across diverse research initiatives
What We're Looking For
Education & Experience:
Required:
Bachelor's of Science in Nursing (BSN) from an accredited institution
Minimum 3 years of clinical research experience
Working knowledge of research methods and federal regulations for human subject research
Must possess or qualify to obtain CCRP or CCRA certification within 6 months of hire
Core Competencies:
Strong leadership and judgment in confidential, regulatory, and ethical matters
Ability to navigate complex research protocols with a sharp eye for detail
Confident representing the department in multi-institutional settings
Excellent communication, planning, and coordination skills
Why Join Us?
At University Health, you'll be part of a team that is passionate about research, innovation, and improving patient outcomes. We offer:
A dynamic, collaborative, and mission-driven environment
Opportunities to lead and influence policy at the institutional and national levels
A commitment to professional development and clinical research excellence
The chance to make a real impact on groundbreaking studies and healthcare transformation
Ready to Elevate Clinical Research?
Bring your skills, passion, and vision to a team that's shaping the future of healthcare research. Apply today to become our Senior Clinical Research Coordinator.