Clinical research associate jobs in The Woodlands, TX - 92 jobs

ARTIDIS AG is a clinical-stage health-tech start-up founded in Basel, Switzerland, that has developed the first nanomechanical signature for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, allowing physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system. ARTIDIS enables professionals to design personalized cancer treatment plans tailored to individual patients' needs and desired outcomes. Job Purpose ARTIDIS is a medical device start-up company that conducts clinical studies to validate and develop new cases for its medical products. Given that ARTIDIS's medical devices are unique, the clinical studies are designed and supervised directly by ARTIDIS. The Senior Clinical Research Associate (SCRA) is an integral part of the Clinical Operations Team which manages the clinical studies. SCRAs work hand in hand with Clinical Quality Development, Clinical Research Associates (CRAs) and Clinical Study Managers (CSMs) to ensure that all clinical studies comply with the approved study protocols and that Good Clinical Practice (e.g. ISO14155:2020, ISO 20916:2019 and/or ICH-GCP E6(R2) as applicable) are being followed. SCRAs also ensure that studies are performed in accordance with applicable regulatory, national and contractual requirements. SCRAs work on all aspects of clinical studies in ARTIDIS's study sites globally, providing specific oversight on clinical study monitoring activities, clinical study reporting and clinical study processes with emphasis on quality assurance, quality control, compliance and auditing. Duties and Responsibilities Monitors the conduct and progress of the study with focus on all quality related aspects of a study and acts as a main contact point for CRAs and CSMs. Trains and supports CRAs in all their duties as necessary. Provides quality assurance review of all study specific documents. Performs site audits, including source document review, as applicable. Assesses effectiveness of study processes and need for additional training of study teams. Performs periodic internal audits of the documentation of the Trial Master File and of the overall study conduct and compliance with the protocol and applicable regulations. Reviews contracts and budgets and ensures adherence to deliverables and timelines. Acts as a main line of communication between the internal ARTIDIS study team and the internal ARTIDIS Quality team. Qualifications Bachelor's degree in a scientific discipline or related field required, or an equivalent combination of education and work experience. 5+ years experience in conducting clinical studies, including both single-center and international multi-center studies. Thorough knowledge of regulatory guidelines and regulations and applicable GCP standards for medical devices. Knowledge of clinical/health systems and practices appropriate to the country/region where study-related activities are conducted. Skilled in the use of statistical, technical, and database computer applications. Self-driven and able to work effectively in a fast-paced environment with minimal supervision. Collaborative with a team-player attitude, pragmatic approach and creative problem-solving capabilities. Ability to thrive with minimal supervision. Strong organizational skills and an ability to multitask with a thorough attention to detail. Accountable and able to maintain a strong commitment to producing work of quality. Ability to communicate and interact competently and professionally at all levels within a broad, complex, clinical research environment. Excellent oral and written communication skills in English. Working Conditions The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance.

Job DescriptionDescription: Study Coordinator II Department: Study Management Purpose: The Study Coordinator position is responsible for the coordination and administration of clinical studies under the direction of the Site Director, and the Principal Investigator. Position Summary: The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. This position reports to the Site Manager or Site Director. Key Responsibilities (Essential Functions): Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities. Manage multiple concurrent trials Assist with mentoring and training study team members Maintain required records of study activity including study logs, case report forms, and/or regulatory forms Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements. Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc. Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information. Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits. Professional communication and collaborative work ethics with CRAs at Site visits. Order and track supplies or devices necessary for study completion. Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes. Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies. Track enrollment status of volunteers and documentation in Clinical Conductor system. Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc. Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups Collect, process and ship laboratory specimens Adherent to safety and privacy regulations Key Responsibilities may vary depending on work location Experience and Skills: Excellent communication, interpersonal, analytical and problem-solving skills Microsoft Office Suite proficiency Writing and verbal communication skills Knowledge of medical terminology and concepts Proficient typing and data entry skills Strong study documentation skills in compliance with ALCOA+ preferred Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred Ability to work effectively with a team Ability to manage small projects personally and work independently Ability to prioritize and manage multiple projects simultaneously Time management skills Organizational skills Detail oriented with the ability to perform at a high level of accuracy Demonstrates strong critical thinking, problem solving skills Self-motivated Must be results oriented, multi-tasking, quick learner Respond to the urgent needs of the team and show a strong track record of meeting deadlines Special Requirements: Must be fluent in speaking and understanding Spanish and English Foreign Medical Graduate or Medical Assistant with extensive medical knowledge and training Physical Requirements The physical demands described here are 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. Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel Ability to lift and/or move up to 20 pounds Education and Experience: BS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA) Minimum 3 years of experience coordinating clinical trials, including the activities listed above Previous nursing, medical assistant experience in a clinical setting a plus CCRC certification a plus Demonstrated relationship building, with strong verbal and written skills. Ability to successfully coordinate protocols with overlapping timelines Ability to explain importance of GCP guidelines and their application Ability to train others on coordinating responsibilities and protocol adherence Able to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting Strong interpersonal skills with attention to detail a must Proven ethical and professional codes of conduct Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems. The above is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organization and the overall business objectives of the organization. Why JCCT? JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States. We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment. Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors. If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today! EEO JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Requirements:

The Clinical Research Coordinator (CRC) will support the Principal Investigator (PI) in conducting industry-sponsored clinical trials. This role reports to the director of clinical research and is responsible for coordinating and conducting patient study visits, ensuring protocol compliance, maintaining accurate documentation, and managing regulatory files. Prior clinical research experience is highly desired. Key Responsibilities Conduct study visits in collaboration with the Principal Investigator in accordance with approved protocols. Perform venipuncture and process blood samples as required by study protocols. Ensure all study visits are documented accurately and completely, in compliance with protocol requirements, GCP, and regulatory standards. Enter and manage study data in electronic data capture systems, including Veeva EDC and CRIO. Maintain complete and up-to-date regulatory binders and essential trial documentation. Prepare for and support monitoring visits, audits, and inspections. Track study progress and ensure timely completion of study-related tasks. Communicate effectively with study sponsors, CROs, and internal research staff. Adhere to institutional policies, SOPs, and all applicable regulatory requirements. Work Environment & Expectations Direct patient interaction during study visits. Collaboration with physicians, research staff, sponsors, and CROs. Compliance with clinical research regulations and institutional policies. Other duties as assigned. Pay Range:The salary range for the Research Study Coordinator position is $45,000 - $66,000 per year, commensurate with experience and qualifications. FLSA Status:This position is classified as Exempt under the Fair Labor Standards Act (FLSA). EEOC Statement:Next Level Medical is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other protected characteristic. Our commitment to Service-Excellence, Teamwork, Integrity, Innovation, and Compassion extends to our employment practices, ensuring fairness and equal opportunity for all. Requirements Required / Preferred Qualifications 2 years of prior experience as a Clinical Research Coordinator or similar research role strongly preferred. Hands-on experience using Veeva EDC and CRIO is strongly preferred. Proven experience performing venipuncture and handling blood samples. Familiarity with clinical trial protocols, informed consent processes, and regulatory documentation. Strong organizational skills with attention to detail. Ability to manage multiple studies and priorities simultaneously. Excellent written and verbal communication skills.

Who we are: ManhattanLife Insurance and Annuity Company was founded in 1850, the Company's longevity makes it one of the oldest and most reliable health and life insurance companies in the country. Operating successfully for 175 years is a testimony to ManhattanLife's enduring history, and an indicator of the reliability of our future. ManhattanLife's headquarters are in Houston, TX and the company is continually growing with multiple office locations nation-wide. ManhattanLife offers attractive employee benefits starting day one, including immediate coverage under our health, dental and vision plans. We offer flexible schedules, including shortened hours on Fridays, free parking, company-wide events, professional development (LOMA testing) and a company-wide wellness program. Scope and Purpose: The Operations and Research Coordinator will provide direct administrative support to the Chief of Staff and Vice President of Sales and Account Management. In this role, you will be assisting our Marketing and Operations departments. The ideal candidate will be adaptable, detail oriented, highly organized, and comfortable working in a fast-paced environment. Duties and Responsibilities: Conduct product research and market rate studies in specific regions. Create and modify PowerPoint presentations. Assist with RFP for our Voluntary Benefits department. Coordinate and schedule meetings and projects as requested. Perform various administrative tasks including but not limited to letter writing, spreadsheet creation, report reviews, etc. Collaborate internally with multiple different divisions on projects. Support cross-functional initiatives between sales and operations. Help document process improvements and workflows. Coordinate between departments to ensure smooth project execution. Assist in planning and managing small special projects across departments. Help track timelines, deliverables on projects. Complete ad hoc administrative tasks and other duties as needed. Minimum Qualifications: High School Graduate or equivalent (GED); financial or insurance industry knowledge preferred. Knowledge, Skills and Abilities: Excellent interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community. Ability to coordinate multiple streams of work independently with close attention to detail. Ability to make procedural decisions and judgments on sensitive, confidential issues. Computer literate; demonstrates proficiency in the use of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Possess effective time management and prioritization skills. Travel Requirements: This position may require light travel within a ten-mile radius from one office location to another as needed. Professional Development: Establish annual objectives for professional growth. Keep pace with developments in the discipline. Learn and apply technologies that support professional and personal growth. Participate in the evaluation process. 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 enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle or feel objects, type, and use mouse; reach with hands and arms and talk and/or hear. The employee is required to sit for extended periods of time. The position may require lifting, pulling or moving items weighing upwards of 10 pounds as it relates to office or desk supplies. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee regularly works in an office environment. This role routinely uses standard office equipment such as computers, phones via WebEx, physical phone while in office, and photocopiers when necessary. Other Duties: Please note this is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to the job at any time without notice. AAP/EEO Statement: ManhattanLife prohibits discrimination based on race, religion, gender, national origin, age, disability, veteran status, marital status, pregnancy, gender expression or identity, sexual orientation, or any other legally protected status. EOE Employer/Vet/Disabled. ManhattanLife values differences. We are committed to fostering an environment that attracts and retains a diverse workforce. With individuals from a variety of backgrounds, ManhattanLife will be better equipped to service our customers, increase innovation, and reduce risks. We encourage the unique perspectives of individuals and are dedicated to creating a respectful and inclusive work environment.

The Clinical Research Coordinator II will ensure that quality research is conducted at the 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. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure 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 Certification on a timely basis. 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: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Striving to meet Sponsor subject enrollment goals for their assigned protocols at 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 2Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required; Bachelor's degree preferred Foreign Medical Graduates preferred Experience: At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. 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.

Job DescriptionSalary: $28.00 - $34.00 Hourly Clinical Research Coordinator II Location: Houston, Texas (Full-Time, On-Site) Research Axsendo Clinical Research is a rapidly growing, multi-market clinical research organization specializing in Neurology, Cardiology, Metabolic Disease, Vaccines, and Medical Devices. Our Houston site is expanding and we are seeking a skilled, service-minded Clinical Research Coordinator II to join our team. This role is ideal for experienced coordinators who can independently execute study visits, support study startup, maintain high-quality documentation, and contribute to a best-in-class patient and sponsor experience. Position Overview The Clinical Research Coordinator II manages the day-to-day execution of assigned clinical trials with a high level of autonomy. This includes conducting study visits, supporting investigators, ensuring protocol compliance, maintaining audit-ready documentation, and collaborating with sponsors/CROs. The ideal candidate has strong operational discipline, excellent patient communication skills, and the ability to execute visits with speed, accuracy, and professionalism. Key Responsibilities Patient & Protocol Management Independently conduct study visits, including consenting, assessments, vital signs, questionnaires, sample collection, and follow-up Read, interpret, and maintain full working knowledge of assigned research protocols Conduct pre-screening and EMR-based feasibility reviews to identify eligible candidate patients Coordinate eligibility discussions with the Principal Investigator Obtain and document informed consent in accordance with ICH-GCP and site SOPs Prevent out-of-window procedures and ensure all required assessments occur per protocol schedule Safety & Regulatory Compliance Report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the IRB and sponsor as required Maintain complete, accurate, and ALCOA-compliant source documentation Ensure accurate Investigational Product (IP) management and accountability Collect and process laboratory specimens per protocol, including preparing shipments and completing lab documentation Maintain up-to-date temperature logs, accountability logs, and essential documentation Data & Documentation Excellence Complete timely and accurate EDC entries and resolve queries promptly Understand and accurately use all study-related data collection instruments Ensure all Case Report Forms (CRFs) and patient tracking logs are complete and accurate Maintain audit-ready source, regulatory, and IP documentation at all times Monitoring & Sponsor Interaction Prepare for monitoring visits by organizing source documents, resolving outstanding action items, and addressing prior queries Support monitors during visits and coordinate any required follow-up Maintain consistent communication with sponsors and CROs regarding data, queries, and operational needs Operational Coordination Plan and prepare subject visits, coordinating room availability, equipment, and supplies Work closely with site administration to ensure clinic readiness Collaborate with investigators, sub-investigators, and cross-functional team members to support seamless study execution Qualifications Minimum 12 years of direct clinical research experience required Demonstrated ability to independently conduct study visits and manage multiple protocols Strong understanding of ICH-GCP, safety reporting, sample handling, and data quality standards Experience with EMR, EDC, CTMS, and electronic source systems Strong communication skills and a service-oriented, patient-centered mindset Superior organizational skills with the ability to manage multiple competing priorities Ability to remain calm, timely, and precise during high-volume or fast-paced clinic days Preferred Qualifications Phlebotomy and EKG training Certified Medical Assistant (CMA) or clinical credential Medical terminology proficiency Bilingual (Spanish/English) a strong plus Experience in cardiology, neurology, metabolic disease, or device trials Why Join Axsendo Opportunity to contribute to a growing research organization with expanding multi-market operations Exposure to diverse therapeutic areas and complex study portfolios A supportive team culture centered around excellence, integrity, and professional growth Continued training and advancement opportunities within Axsendos clinical operations pathway

The Clinical Research Coordinator functions as an integral part of the Research Team in clinical trial management at Oncology Consultants. The Clinical Research Coordinator is involved in multiple aspects of the research process under the general supervision of the Research Department Administrator. Requirements ESSENTIAL DUTIES AND RESPONSIBILITIES: Consistently exhibits behavior and communication skills that demonstrate commitment to superior customer service, including quality, care and concern with each and every internal and external customer. Applies knowledge of study design to evaluate protocol feasibility at the site. Assists Regulatory staff in preparing and submitting documents to institutional review board. Participate in study site initiation activity Attends and participates in investigator meetings and clinical trial conferences as directed. Participates in subject/patient recruitment and evaluation of eligibility. Reviews and verifies required source documents in subject's medical record to confirm study eligibility. Reviews inclusion/exclusion criteria with investigator to assure subject eligibility. Conducts interviews to assess the subject's ability and willingness to follow and complete study procedures and visits. Maintains patient screening enrollment logs. Reviews protocol requirements, informed consent form and follow-up procedures with potential study subjects. Follows randomization procedures per protocol. Ensures that study drugs are dispensed as per protocol by the study team or research pharmacy and that all study drug accountability records are maintained. Reviews returned drugs for compliance and documents findings. Direct care in study compliance throughout the research experience and may include. Peripheral Venipuncture per OC standard Ensures appropriate specimen collection, batching and shipping as required. Work collaboratively with the site staff to appropriately process the specimens Prepare and ship the study required specimen, per protocol manual. Obtain results and report to the attending physician investigator. Attend all clinic visits with the attending physician investigator and assist in following the study guidelines. Documents protocol deviations and exemptions. Obtains and reviews original source documents (e.g., recordings, scans, tests, procedure results). Abstracts data from medical records, clinic, consultation and referral notes to study forms and flow sheets. Resolves data queries. Schedules sponsor monitoring. Prepares case report forms and collects source documents for sponsor / audit review. Prepares for and participates in FDA inspections. Communicates effectively with subjects, research team, IRB's and sponsors Additional Duties and Responsibilities: Participates in educational and training activities. Attends continuing education offerings Supports and assists management team with department projects. Assist in maintenance of budgetary data for each clinical trial. Assist in planning department coverage (patient clinic visits, data management, meetings. Education and/or Experience: Degree in the life sciences or health sciences such as Registered Nurse (R.N.), Doctor in Philosophy (Ph.D.), Medical Doctorate (M.D.), other. Continuing education participation is expected, and research certification through a recognized national organization is encouraged. (SOCRA, ACRP) NIH protection of Human subjects on line course will be required annually IATA training will be required every 2 years LANGUAGE SKILLS: • Strong Verbal and written communication skills • Proficient in written and verbal English • Bilingual is a plus COMMENTS: This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of this job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. How You'll Make An Impact Ability to understand and follow institutional SOPs Participate in recruitment and pre-screening events (may be at another location) Assist with preparation of outreach materials Identify potential participants by reviewing medical records, study charts and subject database Assist with recruitment of new participants by conducting phone screenings Request medical records of potential and current research participants Schedule visits with participants, contact with reminders Obtain informed consent per Care Access Research SOP, under the direction of the CRC Complete visit procedures as required by protocol, under the direction of the CRC Collect, process and ship specimens as directed by protocol, under the direction of the CRC Record data legibly and enter in real time on paper or e-source documents Request study participant payments Update all applicable internal trackers and online recruitment systems Assist with query resolution Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs Assist with inventory and ordering equipment and supplies Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability and willingness to work independently with minimal supervision Ability to learn to work in a fast-paced environment Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure Contribute to team and site goals Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, “can do” attitude Certifications/Licenses, Education, and Experience A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. Phlebotomy Experience and Proficiency Required Some Clinical Research experience preferred California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements, located in Houston, TX Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00 - $33.00 USD per hour for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I-IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. : The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. Responsibilities: General Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study. Develop draft source documents and review the documents for accuracy and clarity prior to study start up. Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate. Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study. Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements. Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment. Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial. Contribute to the SOP review and development as delegated by the Site Director. Study Management Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director. Attend the investigator meeting for each assigned protocol, as appropriate. Completion of IRB study renewals and maintain copies of all IRB communications. In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required. Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator Review and obtain informed consent from potential study volunteers. Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations. Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications. Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects. Ensure timely and accurate CRF completion for each study subject. In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol. Outcome of enrollment and sponsor monitoring visits of all assigned protocols Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives. Skills and Qualifications: Education and experience High School Diploma or its equivalent; College degree preferred. Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff. Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy. Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change. Requirements Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines. Excellent communication skills (interpersonal, written, verbal) Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Traveling PRN Clinical Research Coordinator (CRC) will travel on an as needed basis to affiliated Alcanza Clinical Research sites and will work to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.; Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed; May set up, train and maintain all technology needed for studies. Skills, Knowledge and ExpertiseMinimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus. BLS certified/preferred. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm); Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc Strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

Clinical Research Coordinator I will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering, and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects. Responsibilities include: Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”). Prepare for monitoring visits: All Source Documents organized and readily available. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs readily available. Ongoing Study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB and Sponsor in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications: Bachelors' degree required; Nursing or Health Science preferred. Bilingual preferred (Spanish). Minimum 2 years' experience as a clinical research coordinator. Therapeutic area experience in CKD, nephrology, or vascular access a plus. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.

Job DescriptionClinical Coordinator The Clinical Coordinator supports nursing students by coordinating clinical placements, maintaining clinical partnerships, and ensuring accurate tracking of student clinical hours and records. This role works closely with faculty, clinical sites, and leadership to ensure compliance with all regulatory and academic requirements. Key Responsibilities Develop and maintain clinical affiliations for nursing rotations Coordinate student clinical placements and schedules Ensure students meet all clinical site requirements Track and maintain accurate clinical hours and student records Maintain compliance with state, federal, and institutional regulations Assist with student advising and administrative support Attend required meetings and trainings Perform other duties as assigned Qualifications Bachelor's degree required Minimum of 3 years of clinical coordination experience Strong organizational and communication skills Proficient in Microsoft Office (Excel, Word, Outlook) Ability to manage multiple priorities independently Work Environment Office-based role with moderate noise levels Occasional lifting up to 25 lbs About Us The College of Health Care Professions prepares students for careers in allied health through hands-on training and quality education.

Have you ever wanted to make an impact on the future generation of sonography professionals? Do you have a passion for helping people reach their full potential? Do you love working closely with people? If your answer is yes, this career may be just perfect for you. You responsibilities will include delivering curriculum content to our Sonography students. This includes mentoring and helping the students to become professionals. Qualifications: Associates Degree (required) Bachelors Degree preferred RDCS or RCS (required) RVT or RVS a plus At least 3 years' experience (required) Experience: No teaching experience required. Experience in a wide variety of settings including inpatient and outpatient preferred. Benefits: Health insurance Paid time off 401K with matching Major Holidays off $200/annual reimbursement for CEs and License renewal Competitive Pay Chance for advancement

Where You'll Work Baylor St. Luke's Medical Center is an internationally recognized leader in research and clinical excellence that has given rise to breakthroughs in cardiovascular care, neuroscience, oncology, transplantation, and more. Our team's efforts have led to the creation of many research programs and initiatives to develop advanced treatments found nowhere else in the world. In our commitment to advancing standards in an ever-evolving healthcare environment, our new McNair Campus is designed around the human experience-modeled on evidence-based practices for the safety of patients, visitors, staff, and physicians. The 27.5-acre campus represents the future of healthcare through a transformative alliance focused on leading-edge patient care, research, and education. Our strong alliance with Texas Heart Institute and Baylor College of Medicine allows us to bring our patients a powerful network of care unlike any other. Our collaboration is focused on increasing access to care through a growing network of leading specialists and revolutionizing healthcare to save lives and improve the health of the communities we serve. Job Summary and Responsibilities As a Multi Modality Technologist, you will perform diverse diagnostic imaging procedures across multiple modalities (X-ray, CT, MRI), producing high-quality images for accurate diagnosis. Your versatility is key to efficient operations. Every day you will expertly operate complex equipment, position patients for various examinations, and maintain records while ensuring patient comfort and safety. You will collaborate closely with radiologists, physicians, and other healthcare professionals for optimal imaging. To be successful, you need exceptional technical proficiency in multiple modalities, a comprehensive understanding of diverse anatomical structures, and excellent problem-solving skills. Your adaptability, prioritization, and meticulous attention to detail will be paramount for accurate and timely diagnostic results. Utilizes portable phones for communication convenience. Conducts staff rounding and performance appraisals and reports results to the Clinical Director. Rotate staff roles as appropriate within the lab to minimize radiation exposure boredom. Oversees vendor and application specialist visits, assuring adherence to hospital protocols. Coordinates own PTO with other SLCs to ensure adequate coverage of his/her area Whenever possible, assign yourself as the 4th person in a room for flexibility in making rounds to all rooms within the scope of responsibility (CST or RT) for consistent supervision, help with breaks or emergency situations. Job Requirements Minimum Required: Two (2) years of experience in a cardiac cath lab or two (2) yearsof surgical tech experience in a cardiovascular operating room and Associates Other, upon hire or Other Completion of an approved training program (ARRT and/or CST), upon hire Basic Life Support - CPR, within 14 - days and Certified Surgical Technologist, upon hire or Medical Radiographer: TX, upon hire or Registered Technologist Radiography ARRT, upon hire

ARTIDIS AG is a clinical-stage health-tech start-up company founded in Basel, Switzerland that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, intended to allow physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system. ARTIDIS intends to enable professionals to design personalized cancer treatment plans tailored to individual patients' needs and desired outcomes. Job Purpose ARTIDIS is a medical device start-up company that conducts clinical studies to validate and develop new cases for its medical products. Given that ARTIDIS's medical devices are unique, the clinical studies are designed and supervised directly by ARTIDIS. The Clinical Study Manager is an integral part of the Clinical Operations Team which manages planned and ongoing clinical studies. The Clinical Study Manager is responsible for overseeing the planning, implementation, and maintenance of clinical studies globally, as well as the development of required clinical documentation. He/she is responsible for ensuring that the study is performed in accordance with applicable regulatory, national, and contractual requirements. Additionally, he/she is responsible that the study conduct is in compliance with the approved study protocol and Good Clinical Practices (e.g., ISO 14155:2020, ISO 20916:2019, or ICH-GCP E6 (R2) as applicable) are followed. Duties and Responsibilities Design, planning, implementation, overall direction, and management of clinical studies for medical devices. Management of all aspects of clinical studies, planning, execution, and close out, including oversight and day-to-day management. Ensuring that the Clinical Operations Team and external partner(s) receive study-specific training (identification of site staff training needs, support the development of training material, and delivery of training). Initiation, coordination, and responsibility for study protocol development and development of other operational documents as well as any updates/amendments to those documents according to regulatory and GCP requirements. Management of resources and timelines associated with all study start-up, implementation, conduct, and close-out activities. Ensuring the proper setup and maintenance of the sponsor file, including periodic reviews. Ensuring that investigational products and other study supplies are distributed and tracked and that sites at all times have required products for the performance of the study. Oversight of the study subject enrolment and clinical monitoring activities at study sites.Monitoring study progress to assure compliance with protocol requirements, QMS, and regulatory requirements as well as GCP of study sites. Identification and resolution of issues that may impact the conduct of the study or the necessary quality, timeline, or budget objectives. Accurate tracking of key study activities and maintenance study metrics for routine reporting. Ensuring that payments to sites and other vendors are tracked and performed according to the agreement. Ensuring that safety documentation and reporting are managed according to protocol, applicable processes of the QMS and regulatory, as well as local requirements. Conducting remote data monitoring and on-site visits (site initiation and training, monitoring, and close-out) following national regulations, GCP, and quality standard operating procedures as set out in the QMS. Having oversight and acting as contact with study sites and ensuring that all relevant communication is filed appropriately. Ensuring that sponsor and site file(s) are up-to-date and completed prior to archiving. Perform site audits, including source document review, as applicable. Plan and conduct internal and external meetings with study stakeholders (e.g., Investigator meetings).Being comfortable with measurement procedures of the ARTIDIS Medical Device. Qualifications Degree in a scientific discipline or related field, or an equivalent combination of education and work experience. Minimum 5 years of medical device clinical study management experience in a leading position. Experience of the entire scope of medical device clinical studies, from drafting study proposals, preparation of study-specific documents, preparation and submissions to regulatory authorities and ethic committees/institution review boards, study initiation, study conduct, and study close-out. Advanced hands-on experience with guidelines related to GCP and applicability for medical devices and regulatory environment. Hands-on experience with regulatory guidelines and regulations and applicable GCP standards for medical devices. Excellent oral and written communication skills in English. Independent mindset, ability to self-organize and take ownership of assigned duties. Team player with a pragmatic approach and creative problem-solving capabilities. Thriving in a dynamic start-up environment, displaying a high level of flexibility, adaptability, and a hands-on mentality. Characterized by integrity, loyalty, discretion, and reliability. Working Conditions ARTIDIS is a start-up company with an intrinsically motivated international team. Our company offers an excellent environment for fostering professional development while ensuring a promising opportunity to learn and share know-how in a very agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort will be rewarded with challenging tasks, the possibility of taking responsibility, a highly driven team, and working serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance. The job involves 20% travel.

Study Coordinator II Department: Study Management Purpose: The Study Coordinator position is responsible for the coordination and administration of clinical studies under the direction of the Site Director, and the Principal Investigator. Position Summary: The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. This position reports to the Site Manager or Site Director. Key Responsibilities (Essential Functions): Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities. Manage multiple concurrent trials Assist with mentoring and training study team members Maintain required records of study activity including study logs, case report forms, and/or regulatory forms Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements. Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc. Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information. Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits. Professional communication and collaborative work ethics with CRAs at Site visits. Order and track supplies or devices necessary for study completion. Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes. Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies. Track enrollment status of volunteers and documentation in Clinical Conductor system. Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc. Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups Collect, process and ship laboratory specimens Adherent to safety and privacy regulations Key Responsibilities may vary depending on work location Experience and Skills: Excellent communication, interpersonal, analytical and problem-solving skills Microsoft Office Suite proficiency Writing and verbal communication skills Knowledge of medical terminology and concepts Proficient typing and data entry skills Strong study documentation skills in compliance with ALCOA+ preferred Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred Ability to work effectively with a team Ability to manage small projects personally and work independently Ability to prioritize and manage multiple projects simultaneously Time management skills Organizational skills Detail oriented with the ability to perform at a high level of accuracy Demonstrates strong critical thinking, problem solving skills Self-motivated Must be results oriented, multi-tasking, quick learner Respond to the urgent needs of the team and show a strong track record of meeting deadlines Special Requirements: Must be fluent in speaking and understanding Spanish and English Foreign Medical Graduate or Medical Assistant with extensive medical knowledge and training Physical Requirements The physical demands described here are 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. Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel Ability to lift and/or move up to 20 pounds Education and Experience: BS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA) Minimum 3 years of experience coordinating clinical trials, including the activities listed above Previous nursing, medical assistant experience in a clinical setting a plus CCRC certification a plus Demonstrated relationship building, with strong verbal and written skills. Ability to successfully coordinate protocols with overlapping timelines Ability to explain importance of GCP guidelines and their application Ability to train others on coordinating responsibilities and protocol adherence Able to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting Strong interpersonal skills with attention to detail a must Proven ethical and professional codes of conduct Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems. The above is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organization and the overall business objectives of the organization. Why JCCT? JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States. We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment. Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors. If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today! EEO JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Salary Description $18-$25 / HR

About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I-IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. : The Clinical Research Coordinator II is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC II completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. Responsibilities: General Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study. Develop draft source documents and review the documents for accuracy and clarity prior to study start up. Develop a mechanism for subject recruitment and ongoing communications with PCP and nursing staff as appropriate. Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study. Manage studies with sponsor, and Principal Investigator to ensure compliance with protocol requirements. Manage studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment. Communication of all protocol related issues/problems to the appropriate management staff, including but not limited to questions regarding the conduct of the clinical trial. Contribute to the SOP review and development as delegated by the Site Director. Study Management Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director. Attend the investigator meeting for each assigned protocol, as appropriate. Completion of IRB study renewals and maintain copies of all IRB communications. In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required. Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator Review and obtain informed consent from potential study volunteers. Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations. Maintain organized, accurate and complete study records including but not limited to regulatory documents, signed informed consents, IRB correspondence/approvals, source documentation, drug dispensing logs, subject logs and study-related communications. Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects. Ensure timely and accurate CRF completion for each study subject. In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol. Outcome of enrollment and sponsor monitoring visits of all assigned protocols Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives. Skills and Qualifications: Education and experience High School Diploma or its equivalent; College degree preferred. Two (2) to four (4) years of experience OR certification as a Clinical Research Coordinator Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff. Demonstrate the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy. Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change. Requirements Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines. Excellent communication skills (interpersonal, written, verbal) Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Location: Houston, Texas (Full-Time, On-Site) Research Axsendo Clinical Research is a rapidly growing, multi-market clinical research organization specializing in Neurology, Cardiology, Metabolic Disease, Vaccines, and Medical Devices. Our Houston site is expanding and we are seeking a skilled, service-minded Clinical Research Coordinator II to join our team. This role is ideal for experienced coordinators who can independently execute study visits, support study startup, maintain high-quality documentation, and contribute to a best-in-class patient and sponsor experience. Position Overview The Clinical Research Coordinator II manages the day-to-day execution of assigned clinical trials with a high level of autonomy. This includes conducting study visits, supporting investigators, ensuring protocol compliance, maintaining audit-ready documentation, and collaborating with sponsors/CROs. The ideal candidate has strong operational discipline, excellent patient communication skills, and the ability to execute visits with speed, accuracy, and professionalism. Key Responsibilities Patient & Protocol Management • Independently conduct study visits, including consenting, assessments, vital signs, questionnaires, sample collection, and follow-up • Read, interpret, and maintain full working knowledge of assigned research protocols • Conduct pre-screening and EMR-based feasibility reviews to identify eligible candidate patients • Coordinate eligibility discussions with the Principal Investigator • Obtain and document informed consent in accordance with ICH-GCP and site SOPs • Prevent out-of-window procedures and ensure all required assessments occur per protocol schedule Safety & Regulatory Compliance • Report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the IRB and sponsor as required • Maintain complete, accurate, and ALCOA-compliant source documentation • Ensure accurate Investigational Product (IP) management and accountability • Collect and process laboratory specimens per protocol, including preparing shipments and completing lab documentation • Maintain up-to-date temperature logs, accountability logs, and essential documentation Data & Documentation Excellence • Complete timely and accurate EDC entries and resolve queries promptly • Understand and accurately use all study-related data collection instruments • Ensure all Case Report Forms (CRFs) and patient tracking logs are complete and accurate • Maintain audit-ready source, regulatory, and IP documentation at all times Monitoring & Sponsor Interaction • Prepare for monitoring visits by organizing source documents, resolving outstanding action items, and addressing prior queries • Support monitors during visits and coordinate any required follow-up • Maintain consistent communication with sponsors and CROs regarding data, queries, and operational needs Operational Coordination • Plan and prepare subject visits, coordinating room availability, equipment, and supplies • Work closely with site administration to ensure clinic readiness • Collaborate with investigators, sub-investigators, and cross-functional team members to support seamless study execution Qualifications • Minimum 1-2 years of direct clinical research experience required • Demonstrated ability to independently conduct study visits and manage multiple protocols • Strong understanding of ICH-GCP, safety reporting, sample handling, and data quality standards • Experience with EMR, EDC, CTMS, and electronic source systems • Strong communication skills and a service-oriented, patient-centered mindset • Superior organizational skills with the ability to manage multiple competing priorities • Ability to remain calm, timely, and precise during high-volume or fast-paced clinic days Preferred Qualifications • Phlebotomy and EKG training • Certified Medical Assistant (CMA) or clinical credential • Medical terminology proficiency • Bilingual (Spanish/English) a strong plus • Experience in cardiology, neurology, metabolic disease, or device trials Why Join Axsendo • Opportunity to contribute to a growing research organization with expanding multi-market operations • Exposure to diverse therapeutic areas and complex study portfolios • A supportive team culture centered around excellence, integrity, and professional growth • Continued training and advancement opportunities within Axsendo's clinical operations pathway

Clinical Research Coordinator I will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering, and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects. Responsibilities include: Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”). Prepare for monitoring visits: All Source Documents organized and readily available. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs readily available. Ongoing Study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB and Sponsor in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications: Bachelors' degree required; Nursing or Health Science preferred. Bilingual preferred (Spanish). Minimum 2 years' experience as a clinical research coordinator. Therapeutic area experience in CKD, nephrology, or vascular access a plus. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.