Senior Clinical Coordinator
Clinical research associate 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.
Senior Clinical Research Associate
Clinical research associate job in San Antonio, TX
Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties
* All aspects of site and registry management as prescribed in the project plans
* Organize and make presentations at Investigator Meetings
* Report, write narratives and follow-up on serious adverse events
* Review progress of projects and initiate appropriate actions to achieve target objectives
* You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required
* Participate in the development of protocols and Case Report Forms as assigned
* Interact with internal work groups to evaluate needs, resources and timelines
Qualifications
* 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment
* Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines
* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas
* Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process
* Good planning, organization and problem solving abilities
* Good communication and interpersonal skills
Additional Information
All your information will be kept confidential according to EEO guidelines.
Scientist, Study Manager
Clinical research associate 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 associate 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 associate 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 associate 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 associate 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 San Antonio
Clinical research associate 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 associate job in San Antonio, TX
+ Under general supervision of the Research Director, coordinates and manages all aspects of clinical studies involved in prostate and bladder oncology, including but not limited to subject screening, recruitment, data entering, abstracting, and assessment.
+ Execute, manage, and coordinate research protocols, as directed by the Director of Research and/or Principal Investigator (PI); may coordinate the data collection and operations of several concurrent clinical research studies under the guidelines of research protocols and regulating agency policies.
+ Support the management and coordinating the tasks of single or multiple clinical research studies, depending on their size and complexity; acting as an intermediary between services and departments while overseeing data and specimen collection; manage and report on study results, create, clean, update, and manage databases and comprehensive datasets as well as renewals and modifications of protocol applications and the implementation of new studies
Job Type & Location
This is a Contract to Hire position based out of San Antonio, TX.
Job Type & Location
This is a Contract to Hire position based out of San Antonio, TX.
Pay and Benefits
The pay range for this position is $23.00 - $28.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in San Antonio,TX.
Application Deadline
This position is anticipated to close on Dec 12, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Clinical Research Coordinator RN
Clinical research associate 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
Clinical Research Coordinator
Clinical research associate job in Austin, TX
Job Description Experienced Research Coordinator needed to continue building and lead a newly growing research department. Will have the opportunity to help create a premier research facility. We will provide the necessary support, budget, staff, etc. You would work closely with our PI and Sub-Is on the various studies. Will be working in highly motivated large private practice urology group with 30+ providers.
Job Relationships:
Reports to the Research Manager
Collaborates with experienced patient navigators, IT, data management, and Urology America clinical research staff.
Qualifications:
Must have knowledge of and experience with relevant federal and state regulatory guidelines.
Must have > 5yrs experience with conducting clinical trials.
Urology based clinical experience preferred.
Experience with evaluating and implementing study protocols and budgets.
Certification via ACRP or the equivalent preferred.
Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
Effective time management and the ability to prioritize work.
Excellent communication skills and the ability to interact with all levels of management, staff, and physicians.
Key Responsibilities:
Work to build the research department in scope, size, reputation, and professionalism.
Assist with recruitment of studies, budget evaluation and negotiation, protocol evaluation, communication with study sponsors.
Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
Obtain and maintain consent of patients with the highest ethical standards.
Work with other research department staff in a leadership role including management, training, delegation of responsibilities, hiring, etc.
Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc.
Communicate with and support patients and their families as necessary.
Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records.
Must have or gain knowledge of relevant software/programs.
Have a basic and working knowledge of trial design, statistical methods, etc.
Triage, record, and report adverse events. Record and report any protocol deviations.
Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls.
Create and maintain department SOPs, NDAs, CVs, certifications, etc.
Evaluate, purchase, maintain necessary equipment.
]Maintain HIPAA compliant communication and confidentiality, at all times.
Maintain study budgets and monitor invoicing, billing, and payments.
Participate in site visits, SIVs, monitoring, etc.
Complete necessary study close-out steps and documentation.
Assist with other duties assigned.
Performance Requirements:
Knowledge
Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
Understanding of medical terminology.
Skills
Ability to use multi-line phone systems and basic computer systems.
Interpersonal communication with internal staff and external customers.
Skill in evaluating and implementing study protocols and budgets.
Skill in reading medical chart terminology.
Time Management.
Abilities
Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
Elicit appropriate information for patients to clinic staff.
Ability to read and understand information and ideas presented in writing.
Ability to apply general rules to specific problems to produce answers that make sense - deductive reasoning.
Physical Demands and Work Environment:
The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:
Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.
Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.
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Clinical Research Coordinator
Clinical research associate 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
Clinical research associate 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
Clinical research associate job in Cedar Park, TX
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Company Conformance Statements
In the performance of their respective tasks and duties all employees are expected to conform to
the following:
• Perform quality work within deadlines with or without direct supervision.
• Interact professionally with other employees, customers and suppliers.
• Work effectively as a team contributor on all assignments.
• Work independently while understanding the necessity for communicating and
coordinating work efforts with other employees and organizations.
Position purpose
The Clinical Research Coordinator (CRC) is a specialized research professional working with
and under the direction of the Director and Clinical Principal Investigator (PI). The CRC
supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in
the conduct of the study.
Responsibilities/Duties/Functions/Tasks:
• Communicate study requirements to all individuals involved in the study.
• Develop and implement recruitment strategies in accordance with Impact Research
and IRB requirements and approvals.
• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria.
• Entry of participant information and study visit procedures into the Clinical Trial
Management System to ensure billing to appropriate funding source.
• Maintains adequate inventory of study supplies. When handling investigational
drugs/devices, follows the sponsor protocol and/or Impact Research Policy on
Investigational Drug/Device Accountability.• Complete study documentation and maintenance of study files in accordance with
sponsor requirements and Impact Research policies and procedures including, but not
limited to, consent forms, source documentation, narrative notes if applicable, case report
forms, and investigational material accountability forms.
• Maintains effective and ongoing communication with sponsor, research participants,
Director and PI during the course of the study.
• Manage the day to day activities of the study including problem solving, communication
and protocol management.
• Collects and reports ongoing patient recruitment/ enrollment metrics to Director and PI.
• Arranges secure storage of study documents that will be maintained according to Good
Clinical Practice guidelines or for the contracted length of time, whichever is longer.
• Protects the rights and welfare of all human research participants involved in research in
accordance with Federal regulations
• Cooperates with Impact Research compliance and monitoring efforts regarding the
access, use, and disclosure of PHI and reports instances of noncompliance to the
appropriate compliance office.
• Other duties as assigned.
Qualifications
Education: High school diploma/GED certificate required. Associates degree from an
accredited university preferred.
Experience: Minimum 1-2 years of clinical research experience.
Other Requirements: None
Performance Requirements:
• Knowledge of grammar, spelling, and punctuation.
• Knowledge of purchasing, budgeting, and inventory control.
• Skill in taking and transcribing dictation and operating office equipment.
• Skill in answering the phone and responding to questions.
• Skill in time management, prioritization, and multitasking.
• Skill in writing and communicating effectively.
• Ability to work under pressure, communicate and present information.
• Ability to read, interpret, and apply clinic policies and procedures.
• Ability to identify problems, recommend solutions, organize and analyze information.
• Ability to multi-task, establish priorities, and coordinate work activities.
• Ability to competently use Microsoft Office, including Word, PowerPoint, Excel, and
appropriate practice management software.
• Must be able to lift up to 25 lbs.
• Must be able to travel and MVR
Equipment Operated: Standard office equipment including computers, fax machines, copiers,
printers, telephones, etc.
Work Environment: Position is in a well-lighted medical office environment. Occasional
evening and weekend work.
Physical Requirements: Must possess the physical and mental abilities to perform tasks such as
sitting for 90 percent of the day; manual dexterity to operate office machines including computer
and calculator; stooping, bending to handle files and supplies; and mobility to complete errands
or deliveries. Stress can be triggered by multiple staff demands and deadlines.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Auto-ApplyPatient Coordinator - Dr. Gates
Clinical research associate job in San Antonio, TX
Full-time Description
Job Title: Clinic Coordinator
This Clinical Coordinator will be assigned to Dr. Stephen Gates.
Travel between the following locations will be required: Medical Center, Westover Hills and Quarry Area
Job Summary:
We are seeking a dedicated and organized Patient Coordinator to join our healthcare team. The ideal candidate will be responsible for managing patient interactions, ensuring a smooth and efficient patient experience, and supporting the administrative functions of our practice.
Key Responsibilities:
- Serve as the primary point of contact for patients, addressing inquiries and providing information about services.
- Schedule and confirm patient appointments, ensuring optimal use of time and resources.
- Maintain accurate patient records and ensure compliance with privacy regulations.
- Assist patients with insurance verification and billing inquiries.
- Coordinate communication between patients and healthcare providers to facilitate care.
- Manage patient flow and ensure a welcoming environment in the office.
- Handle administrative tasks such as filing, data entry, and maintaining office supplies.
-Enters clinical charges into EMR.
-Documents patient phone calls, prescription refill messages, and obtains physician signature.
-Manages clinical risk issues for patients/physician.
-Ensures patient phone calls are retrieved and returned in a timely manner.
-Works with Medical Administrative Assist on phone and Athena documentation tasks (buckets).
-Monitors and works “Hold” buckets on Athena Dashboard, assists Professional Reimbursement Department on resolving open claims.
-Addresses concerns and/or complaints from patients, vendors, and staff members; escalates to Clinic Manager as needed.
-Analyzes average patient wait times and makes recommendations for improvement as needed.
-Coordinates Physician meeting schedules, to include finding solutions where scheduling conflicts may exist.
-Coordinates On-Call rounding lists of patients.
-Ensures regulatory compliance and reports any issues to Clinic Manager as they arise.
Requirements
Skills and Qualifications:
- Excellent communication and interpersonal skills.
- Strong organizational and multitasking abilities.
- Proficiency in using electronic health record (EHR) systems and office software.
- Ability to work effectively in a fast-paced environment.
- Knowledge of medical terminology and healthcare processes is a plus.
- Compassionate and patient-focused attitude.
-Requires regular and predictable attendance.
We are an equal opportunity employer and welcome applications from all qualified individuals.
#Clinic1
Salary Description $17.00 starting pay
Early Phase Clinical Research Coordinator Assistant (CRCA)
Clinical research associate job in San Antonio, TX
This is an excellent opportunity for those with clinical experience who want to enter the clinical research industry! 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 Early Phase Clinical Research Coordinator Assistants at our Clinical Trials of Texas site in San Antonio!
The Clinical Research Coordinator Assistant is critical in supporting the Clinical Research Coordinators and the research team in providing an impeccable patient experience in every interaction. Your role will include a variety of tasks, from patient recruitment, source documentation, data entry, and direct patient interaction during site visits.
Shift: Monday-Friday, 8:30 AM - 5 PM
Location: 5430 Fredericksburg Rd., Suite 200, San Antonio, TX 78229
Compensation: Up to $21/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.
CRCAs have a clear path to promotion into a Clinical Research Coordinator position!
RESPONSIBILITIES
Exclusively support the Early Phase (Phase 1) clinical operations team
Assist in the recruitment, screening, and enrollment of study participants.
Coordinate and manage the scheduling of trials and maintain communication with participants.
Collect, organize, and process clinical data from trials.
Maintain source documentation from patient visits and protocol activities
Work alongside clinical research coordinators to conduct patient visits.
Once trained, perform phlebotomy, EKGs, and/or other diagnostic procedures as needed
Learn, understand, and comply with rules and regulations governing medical ethics, IRB, GCP, and ICH guidelines
Provide administrative support to research staff by organizing meetings, preparing reports, and maintaining records.
Additional duties as assigned by management.
QUALIFICATIONS
Bachelor's degree preferred but not required
Must have experience with early phase (phase 1) clinical trials
Must have either clinical research experience OR clinical skills, such as taking vitals, phlebotomy, EKGs, etc
Impeccable organizational skills, attention to detail, and people skills, as you will be interacting directly with patients
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, CRCs, other members of the 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 associate job in San Antonio, TX
Senior Clinical Research Coordinator Please read the following job description thoroughly to ensure you are the right fit for this role before applying. 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. xevrcyc Apply today to become our Senior Clinical Research Coordinator.
Research Coordinator I/II
Clinical research associate job in San Antonio, TX
Job Description
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 Assistant
Clinical research associate 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: Assists the clinical research coordinator and the principal investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties. Duties and Responsibilities:
Assists with the creation and completion of study related documents and new study preparation.
Assists with the completion of regulatory submissions and maintains regulatory files as directed.
Acts as a secondary liaison with sponsors.
Assists with the preparation for study monitor visits as directed.
Completes case report forms as directed.
Creates reports as requested.
Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
Assists with subject screening and recruitment as directed.
Updates Clinical Trial Management Software (CTMS) as directed.
Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.
Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.
Education/Experience: High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience. Certificates and Licenses:
Clinical research certification preferred
Knowledge, Skills, and Other Abilities:
Ability to demonstrate competence in oral and written communication
Bilingual (English/Spanish) required
Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
Medical knowledge, including medical terminology
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.
Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.
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 accommodations 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.
Occasional 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.
Perks 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 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 Assistant (CRCA)
Clinical research associate job in San Antonio, TX
This is an excellent opportunity for those with clinical experience who want to enter the clinical research industry! 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 Coordinator Assistants at our Clinical Trials of Texas site in San Antonio!
The Clinical Research Coordinator Assistant is critical in supporting the Clinical Research Coordinators and the research team in providing an impeccable patient experience in every interaction. Your role will include a variety of tasks, from patient recruitment, source documentation, data entry, and direct patient interaction during site visits.
Shift: Monday-Friday, 8:30 AM - 5 PM
Location: 5430 Fredericksburg Rd., Suite 200, San Antonio, TX 78229
Compensation: Up to $21/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.
CRCAs have a clear path to promotion into a Clinical Research Coordinator position!
RESPONSIBILITIES
Assist in the recruitment, screening, and enrollment of study participants.
Coordinate and manage the scheduling of trials and maintain communication with participants.
Collect, organize, and process clinical data from trials.
Maintain source documentation from patient visits and protocol activities
Work alongside clinical research coordinators to conduct patient visits.
Once trained, perform phlebotomy, EKGs, and/or other diagnostic procedures as needed
Learn, understand, and comply with rules and regulations governing medical ethics, IRB, GCP, and ICH guidelines
Provide administrative support to research staff by organizing meetings, preparing reports, and maintaining records.
Additional duties as assigned by management.
QUALIFICATIONS
Bachelor's degree preferred but not required
Must have either clinical research experience OR clinical skills, such as taking vitals, phlebotomy, EKGs, etc
Impeccable organizational skills, attention to detail, and people skills, as you will be interacting directly with patients
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, CRCs, other members of the 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-Apply