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Clinical research associate jobs in Sugar Land, TX

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Clinical Research Associate
Clinical Research Coordinator
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Clinical Trial Coordinator
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Clinical Study Manager
Research Coordinator
  • Clinical Research Coordinator 248023

    Medix™ 4.5company rating

    Clinical research associate job in Houston, TX

    Performs study subject visits by, among other things; Screening and recruiting subjects; Dosing and administering study drugs and/or implementing study methodologies; Accounting for study drugs; Communicating with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators; Collecting, labeling, storing, and shipping specimens collected from subjects in connection with a clinical research trial; Entering patient and research data in systems designated by the Company; and Maintaining patient charts and resolving research queries. Follows Good Clinical Practice Works cooperatively with others Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies; Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms; Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed; Assesses eligibility of potential subjectsthrough methods such as screeninginterviews, reviews of medical records,and discussions with physicians and other healthcare professionals; Oversees subject enrollment to ensure that informed consentis properly obtainedand documented; Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies; Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups; Creates source documents as assigned, such as regarding protocols, memos, patient participation; Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports; Reviews proposed study protocols to evaluate factorssuch as sample collection processes, data management plans,and potential subjectrisks; Instructs research staff in scientific and procedural aspectsof studies including standards of care, informed consentprocedures, or documentation procedures; Collaborateswith Investigators and Company Management to prepare presentations or reports of clinical studyprocedures, results, and conclusions; Communicateswith laboratories or investigators regarding laboratory findings; Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research; Orders drugs or devices necessary for study completion; Documents findings and events in the Company's research CTMS platform and in other binders and platforms as directed; Occasional travel to Company sites, Investigator meetings, and/or Company meetings; and Performs other duties as assigned, including duties routinely performed by the Company's Research Assistants.
    $41k-58k yearly est. 3d ago
  • Senior Clinical Research Associate (level dependent on experience)

    CTI Clinical Trial Services 3.7company rating

    Clinical research associate job in Houston, TX

    Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
    $68k-105k yearly est. 60d+ ago
  • Clinical Study Manager

    Artidis

    Clinical research associate job in Houston, TX

    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.
    $50k-85k yearly est. 60d ago
  • Senior Clinical Research Coordinator - School of Public Health

    Ut Health Science Center at Houston 4.8company rating

    Clinical research associate job in Houston, TX

    We are hiring immediately for a Senior Clinical Research Coordinator to join the UTHealth Houston School of Public Health in Houston, TX. In this position, you will oversee the biospecimen chain of custody, tracking, and inventory, and coordinate with research teams and labs to ensure compliant processing and shipment. The ideal candidate should have prior experience handling biospecimens and coordinating research projects. This position does require travel within the state of Texas. What we do here changes the world. UTHealth Houston is Texas' resource for healthcare education, innovation, scientific discovery, and excellence in patient care. That's where you come in. Once you join us you won't want to leave. It's because we reward our team for the excellent service they provide. Our total rewards package includes the benefits you'd expect from a top healthcare organization (benefits, insurance, etc.), plus: * 100% paid medical premiums for our full-time employees * Generous time off (holidays, preventative leave day, both vacation and sick time - all of which equates to around 37-38 days per year) * The longer you stay, the more vacation you'll accrue! * Longevity Pay (Monthly payments after two years of service) * Build your future with our awesome retirement/pension plan! We take care of our employees! As a world-renowned institution, our employees' wellbeing is important to us. We offer work/life services such as... * Free financial and legal counseling * Free mental health counseling services * Gym membership discounts and access to wellness programs * Other employee discounts including entertainment, car rentals, cell phones, etc. * Resources for child and elder care * Plus many more! Position Summary: Provides management of recruitment, enrollment, scheduling, and monitoring of participants for research within clinical settings. Position Key Accountabilities: * Coordinates and facilitates translational and clinical study procedures, including maintaining strong relationships with clinical partners, planning procedures for recruitment and translational and clinical study procedures, coordinating study initiation, monitoring progress towards recruitment/enrollment milestones, identifying opportunities for improvement, and recommending changes to the study team. * Manages study recruitment and enrollment activities, including identifying eligible participants, enrolling participants, scheduling research activities, monitoring participant progress, and compensating participants according to study regulations and protocols. * Manages IRB documents, submits protocol revisions as needed, and maintains compliance records and binders. * Completes all study forms, study protocols, informed consent, and others as needed. * Collects and processes blood specimens under the direction of a principal investigator or the study team. * Performs other duties as assigned. Certification/Skills: * Clinical research experience in a patient-facing clinical research role. Minimum Education: * Bachelor's degree in a related field is required. Master's Degree in related field preferred. Minimum Experience: * Four (4) years of clinical research experience, including significant experience in a patient-facing clinical research role with a Bachelor's degree required. * Two (2) years of clinical research experience, including significant experience in a patient-facing clinical research role with a Master's degree required. Physical Requirements: Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects. Security Sensitive: This position is a security-sensitive position pursuant to Texas Education Code §51.215 and Texas Government Code §411.094. To the extent that a position requires the holder to research, work on, or have access to critical infrastructure as defined in Texas Business and Commerce Code §117.001(2), the ability to maintain the security or integrity of the infrastructure is a minimum qualification to be hired for and to continue to be employed in that position. Personnel in such positions, and similarly situated state contractors, will be routinely reviewed to determine whether things such as criminal history or continuous connections to the government or political apparatus of a foreign adversary might prevent the applicant, employee, or contractor from being able to maintain the security or integrity of the infrastructure. A foreign adversary is a nation listed in 15 C.F.R. §791.4. Residency Requirement: Employees must permanently reside and work in the State of Texas.
    $39k-52k yearly est. 7d ago
  • Study Coordinator ll

    Johnson County Clintrials

    Clinical research associate job in Houston, TX

    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:
    $39k-57k yearly est. 22d ago
  • Clinical Study Coordinator

    Tranquil Clinical and Research Consulting Services

    Clinical research associate job in Webster, TX

    The role of the Clinical Study Coordinator is to ensure patient safety and wellbeing. The Clinical Study Coordinator will coordinate and perform study visits under the guidance and supervision of the principal investigator. This is an office-based position, working in the same location as the principal investigator or in the designated clinic. To be successful in this role, the Clinical Study Coordinator should be able to perform critical patient evaluations, in addition to recognizing logistical problems and initiating appropriate solutions. Ideal candidates will be patient-focused, detail-oriented, have the ability to multitask, and be able to collaborate with various role players. The Clinical Study Coordinator must be able to work independently, be a team player, and proactively problem solve. Qualifications Bachelors Degree with related clinical experience Experience working on clinical trials for a minimum of 2 years Knowledge of FDA regulations and GCP Accuracy, attention to detail, and ability to set priorities and meet deadlines Basic Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel Other Skills required: Excellent bedside manner and patient-centric focus Excellent time management and social skills Highly motivated with a phenomenal eye for detail Duties and Responsibilities Develop management systems and prepare for study initiation: Assess study feasibility in terms of study's impact on-site resources, labor cost, cost by procedure, the potential for problems (such as serious AEs, noncompliance, the willingness of subjects to participate, protocol deviations, etc.) Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate. Screen and enroll study subjects: Review the study design and inclusion/exclusion criteria with the subject's primary physician Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility Review the protocol, informed consent form and follow-up procedures with potential study subjects Ensure that the current approved informed consent is signed before subjects are screened and enrolled Ensure that the randomization procedure is followed as per protocol guidelines Document protocol exemptions and deviations. Manage study-related activities, subject compliance and documentation: Ensure adherence to protocol requirements Schedule subjects for follow-up visits Assist investigators in assessment of subject response to therapy Review laboratory data, inform investigator of abnormal values and document Report to primary care provider as appropriate Assess and document subject compliance with medications and visits Communicate with pharmacy staff to assure timely and accurate study drug distribution Manage administration of investigational therapy Maintain dispensing logs (if allowed) Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies Oversee specimen collection, storage and shipment Attend study-related meetings as appropriate Communicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues. Record data and study documentation: Record data as directed using the appropriate media or platform Follow procedures for access and security for electronic data entry Review keyed data for accuracy, as needed Send data to the data collection center on a timely basis Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports Correct and edit data as directed and as appropriate. Monitor and report adverse events: Assess, document and record all AEs as outlined in the protocol Report serious AEs o the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol). Regulatory documentation: Know and understand all regulatory requirements associated with the conduct of the study assigned Maintain files and documents as regulations dictate Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.), prepare and submit reports, as required Ensure that all required documentation is complete and appropriately filed. Management of site activities during audits and inspections: Prepare for quality assurance audits and regulatory inspections, as needed Act as contact person before, during and after audits and inspections Provide all required documentation to auditors Make all appropriate corrections as requested by auditors Coordinate site response to audit/inspection findings. Competencies Diversity - Willingness to follow Equal Employment Opportunity (EEO) policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures. Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time. Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals. Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results Cost Consciousness - Works within approved budget; Develops and implements cost-saving measures; Contributes to profits and revenue; Conserves organizational resources. Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. Design - Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail. Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed. Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention. Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things. Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions. Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others. Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals. Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem-solving situations; Uses reason even when dealing with emotional topics. Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness. Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly. Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Visionary Leadership - Displays passion and optimism; Inspires respect and trust; Mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates. Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. WORK ENVIRONMENT This is an office-based position with a clinical unit.
    $39k-57k yearly est. Auto-Apply 60d+ ago
  • Operations & Research Coordinator

    Manhattanlife Insurance & Annuity Company 3.9company rating

    Clinical research associate job in Houston, TX

    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.
    $40k-59k yearly est. 7d ago
  • Clinical Research Coordinator III

    Dm Clinical Research Group

    Clinical research associate job in Sugar Land, TX

    Job Details Sugarland - Sugar Land, TXClinical Research Coordinator III A CRC III will 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. To 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: 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. Conducting and overseeing 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 and overseeing 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, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols. 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). Ability to train and mentor site staff, as needed Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Demonstration of appropriate and timely follow-up on the action items, at their respective sites. 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). Maintaining a working knowledge of Study Participants' Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team. Maintaining a 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) 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. 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 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.
    $38k-57k yearly est. 60d+ ago
  • Clinical Research Coordinator -Traveling PRN

    Alcanza Clinical Research

    Clinical research associate job in Sugar Land, TX

    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.
    $38k-57k yearly est. 29d ago
  • Clinical Research Coordinator I

    Care Access 4.3company rating

    Clinical research associate job in Houston, TX

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prescreen study candidates * Obtain informed consent per Care Access Research SOP. * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines. * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Other Responsibilities * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct. * Communicate clearly verbally and in writing. * Attend Investigator meetings as required. * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management * Maintain effective relationships with study participants and other care Access Research personnel. The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 1-year prior Clinical Research Coordinator experience required * Recent phlebotomy experience required How We Work Together * Location: Position requires onsite work 5 days per week at either the Houston, TX. * Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Physical demands associated with this position Include: * Walking-20% * Standing-20% * Sitting-20% * Lifting-20% * Up to 25lbs Overhead * Driving-20% The expected salary range for this role is $55,000 - $85,000 USD per year 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: ********************************
    $55k-85k yearly 5d ago
  • Clinical Research Coordinator

    Pinnacle Clinical Research

    Clinical research associate job in Houston, 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.
    $38k-57k yearly est. 10d ago
  • Clinical Research Coordinator

    Axsendo Clinical

    Clinical research associate job in Houston, TX

    The Company Are you an ambitious and proactive individual seeking an exciting opportunity in clinical research? Join Axsendo Clinical Research, a rapidly growing network of clinical research sites specializing in Neurology, Cardiology, Metabolic Disease, Vaccines and Medical Devices. We are eager to welcome a dedicated Clinical Research Coordinator to contribute to our dynamic and busy team! The Role Protocol Understanding : Read and comprehend assigned research protocols. Conduct prescreening of potential patients. Enrollment Management: Use the Electronic Medical Record (EMR) to screen eligible patients. Facilitate patient qualification discussions with the Principal Investigator. Report Adverse and Serious Adverse Events to IRB and Sponsor following guidelines. Obtain and document informed consent following ICH/GCP and site SOPs. Ensure timely and accurate data entry based on the ALCOA principle. Monitoring Visit Preparation: Organize and collect data in the electronic source system. Resolve outstanding items from previous monitoring visits. Address and close any queries from prior visits. Keep temperature and accountability logs readily available. Ongoing Study Oversight: Plan subject visits as per protocol-specific schedules. Prevent protocol deviations related to out-of-window procedures. Coordinate with location administration to ensure space and resource availability. Dispense/collect study medication with accurate Investigational Product accountability. Collect and process subject laboratory specimens following protocol. Complete case report forms (CRFs) and other patient tracking information accurately and promptly. Maintain a comprehensive understanding of all data collection instruments and ensure accurate data collection according to the protocol. Qualifications Phlebotomy and EKG Training Preferred Medical Terminology Preferred Certified Medical Assistant Preferred Bilingual a plus
    $38k-57k yearly est. 60d+ ago
  • Clinical Research Coordinator - Psychiatry

    Elixia Health

    Clinical research associate job in Houston, TX

    Summary: The Clinical Research Coordinator (CRC) manages and coordinates clinical research studies, ensuring they are conducted efficiently, ethically, and in compliance with regulatory requirements. The role involves working with principal investigators, research staff, and study participants to oversee all aspects of trials, including recruitment, data management, regulatory compliance, and monitoring participant progress. Duties and Responsibilities: The Clinical Research Coordinator: Performs study subject. Screens and recruits' subjects. Doses and administers study drugs and/or implements study methodologies. Accounts for study drugs. Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators. Accounts for study drugs. Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators. Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial. Enters patient and research data in systems designated by the company. Maintains patient charts and resolves research queries. Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements. Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms. Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals. Oversees subject enrollment to ensure that informed consent is properly obtained and documented. Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups. Creates source documents as assigned, such as regarding protocols, memos, patient participation. Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures. Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions. Communicates with laboratories or investigators regarding laboratory findings. Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research. Orders drugs or devices necessary for study completion. Documents findings and events in the Company's research CTMS platform and in other binders and platforms as directed. Occasional travel to Company sites, Principal Meetings, and/or Company meetings. Performs other duties as assigned. This is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time. Requirements: Minimum high school diploma required. Bachelor's degree in Life Sciences, Nursing, or a related field (preferred). 3 + years Clinical Research Coordinator Experience Required Strong Psychiatric experience required Clinical rating experience preferred Familiarity with Good Clinical Practice (GCP) and regulatory guidelines (FDA, ICH). Certification as a Clinical Research Coordinator (e.g., ACRP, SOCRA) is a plus. Knowledge of clinical trial management software and electronic data capture systems. Competency Requirements: Strong organizational and time management skills. Excellent attention to detail and ability to maintain accurate records. Effective communication skills, both written and verbal. Ability to work independently and collaboratively in a team environment. Proactive problem-solving skills and adaptability in a dynamic setting. Physical Requirements and/or environmental factors: Prolonged periods of sitting at a desk and working on a computer Must be able to lift 20 pounds at a time. Travel to our Houston, Texas site is required.
    $38k-57k yearly est. 7d ago
  • Clinical Research Coordinator (CRC)-FT

    Evolution Research Group

    Clinical research associate job in Houston, TX

    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)
    $38k-57k yearly est. 3d ago
  • Cardiovascular Sonography Clinical Coordinator 5000 Sign on Bonus

    CHCP

    Clinical research associate job in Houston, TX

    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
    $44k-63k yearly est. Auto-Apply 60d+ ago
  • Multi Modal-Clinical Coordinator

    Common Spirit

    Clinical research associate job in Houston, TX

    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 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.
    $44k-63k yearly est. 7d ago
  • Cardiovascular Sonography Clinical Coordinator $5000 Sign on Bonus

    CHCP Healthcare and Educational Services LLC

    Clinical research associate job in Houston, TX

    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
    $44k-63k yearly est. 4d ago
  • Field Clinical Coordinator

    Dozee

    Clinical research associate job in Houston, TX

    Job DescriptionCompany Overview : Dozee Health AI is the pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India's no. 1 RPM Company. We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you'll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models Role Overview: The Field Clinical Coordinator plays a key role in supporting healthcare professionals,primarily nurses, to ensure the effective utilization of clinical systems and devices. This position involves facilitating seamless device installations, guiding staff on proper usage and best practices, and providing on-site support for technical troubleshooting and operational issues Role Training & Assistance for Nurses & Care Teams Deliver hands-on training to nurses and caregivers on device operation, maintenance, and interpretation of readings Provide on-site and remote support to address common device and system issues Ensure compliance with facility protocols and company guidelines during device use Coordinate and facilitate telehealth assessments in collaboration with Nurse Practitioners (NPs) Support nursing teams in performing basic patient reviews for stable patients Maintain strong clinical understanding, communication, and bedside interaction skills On-Site Troubleshooting & Technical Support Respond promptly to service requests to resolve device malfunctions or connectivity issues Diagnose and address minor hardware or software problems, escalating complex cases to the technical support team Replace or maintain faulty devices to ensure uninterrupted clinical operations Ensure all necessary firmware updates are applied to keep devices performing optimally Device Installation & Setup Coordination with the Installation Team to deploy RPM devices (e.g., sensors, monitors, software systems, etc) at healthcare facilities Ensuring proper device calibration, pairing, and network connectivity Performing initial setup tests to verify full functionality before leaving the site Compliance & Safety Adherence Compliance with HIPAA regulations and company policies to ensure patient dataprivacy. Adherence to safety protocols when handling medical-grade electronic devices. Verification that devices meet hospital infection control standards before and after installation. Maintenance of relevant certifications (e.g., CNA, Paramedic, MA) as required for compliance and safety. Documentation & Reporting Log all installation, troubleshooting, and repair activities in the system. Timely reporting of recurring issues to engineering or product teams for improvement. Maintenance of detailed service logs, customer interaction records, and resolution statuses. Inventory & Maintenance Management Maintain an inventory of devices, replacement devices, and peripherals. Track device deployment, retrievals, and replacements in the system. Ensure proper storage and transportation of devices to prevent damage. Communication Coordination Coordination with clinical, install and technical support, engineering, product and logistics teams to ensure seamless service execution. Providing actionable feedback to product development teams based on field observations. Relaying customer complaints and suggestions to higher management for resolution and process improvement. Certifications & Skills: Certifications such as CNA, Paramedic, or Medical Assistant (MA) - At least 1 is required. Valid driver's license and willingness to travel frequently. Experience: Minimum 2-3 years' experience in clinical coordination, medical device installation, or healthcare technology support. Experience working in healthcare environments, preferably skilled nursing facilities. Skills & Competencies: This role requires frequent travel within assigned regions. Strong clinical knowledge and familiarity with healthcare workflows and medical devices. Excellent communication and interpersonal skills. Ability to train and guide clinical staff effectively. Strong troubleshooting and technical problem-solving skills. Attention to detail and ability to maintain accurate records. Ability to work independently in the field while managing multiple priorities. About Dozee (******************* Vision & MissionSave Million lives with Health AI Dozee is India's leading AI-Powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS). A solution that continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities and patient homes. A "Made in India for the World" solution, Dozee has pioneered the world's first non-contact blood pressure monitoring system. Trusted by leading healthcare providers in India, the USA, and Africa, Dozee is transforming patient safety and care by enhancing outcomes and reducing costs. Dozee is adopted by 300+ hospitals and monitors 16000+ beds across 4 countries. Dozee has monitored over 1 Mn Patients, Delivered 35000+ Life Saving Alerts and Saved 10 Mn+ Nursing Hours. VideosScience Behind Dozee : Ballistocardiography & Artificial Intelligence100 Dozee deliver 144 life saving alerts and INR 2.7 Cr of saving - Sattva StudyDozee saves life of a mother at home Leading Healthcare Game changers work with DozeeIntroducing Dozee VSDozee Shravan - A clinical grade RPM service Dozee in News: Bloomberg - Oct 21, 2024From AI Beds to Remote ICUs, Startups are plugging India's health GapsNews18 - Oct 26, 2024Now, You Can Remotely Monitor Your Loved Ones in Hospital With Bengaluru Start-Up's 'Shravan'Analytics India Magazine - Oct 29, 2024Dozee Harness AI for Personalised Patient CareET HealthWorld - Sep 16, 2024We trust AI everyday - From Google Maps to Smartphones, So why not use it to enhance patient safety in healthcare?BW healthcareworld - Oct 29, 2024Dozee's AI-Powered System Predicts Patient Deterioration 16 Hours in Advance - A tertiary care hospital study published in JMIR, validated Dozee's Early Warning System (EWS), showing it identified 97% of deteriorating patients, provided alerts ~19 hours in advance, and generated 5x fewer alerts, reducing alarm fatigue and improving patient outcomes.- A study at King George Medical University, Lucknow, and published in Frontiers in Medical Technology demonstrated that Dozee's automation can potentially save 2.5 hours of nursing time per shift, improving workflow efficiency and allowing more focus on patient care.- A study on remote patient monitoring in general wards published in Cureus found that 90%+ of healthcare providers reported improved care and patient safety, 74% of patients felt safer, and there was a 43% increase in time for direct patient care.- Research by Sattva, an independent consulting firm, demonstrates Dozee's substantial impact: for every 100 Dozee-connected beds, it can save approximately 144 lives, reduce nurses' time for vital checks by 80%, and decrease ICU average length of stay by 1.3 days. Key HighlightsFounded : October, 2015Founders : Mudit Dandwate, Gaurav ParchaniHeadquarters : Bangalore, India \u007C Houston, USA \u007C Dubai, UAEKey Investors & Backers : Prime Ventures, 3one4 Capital, YourNest Capital, Gokul Rajaram, BIRAC (Department of Biotechnology, State Bank of India, and Dinesh Mody Ventures, Temasek Foundation, Horizons VenturesStage : Series A+Team Strength : 280+Business : Providing Continuum of care with AI-powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) for Hospitals and HomeCertifications & Accreditations : ISO13485:2016 Certified, ISO27001:2022 Certified, CDSCO Registered, FDA510K Cleared for the flagship product Dozee Vitals Signs (VS) measurement system and SOC2 Type II CertifiedAchievements- Forbes India 30 under 30- Forbes Asia 100 to Watch- Times Network - India Health Awards 2024 for AI innovation in Bharat Healthcare tech- BML Munjal Award for Business Excellence using Learning and Development- FICCI Digital Innovation in Healthcare Award- Anjani Mashelkar Inclusive Innovation Award Marico Innovation For India Award To know more about life@dozee, click here. Disclaimer: Dozee is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.” Dozee does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Dozee will not tolerate discrimination or harassment based on any of these characteristics We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $44k-63k yearly est. 27d ago
  • Study Coordinator ll

    Johnson County Clintrials

    Clinical research associate job in Houston, TX

    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
    $18-25 hourly 60d+ ago
  • Healthy Human _ Clinical Trials

    Tranquil Clinical and Research Consulting Services

    Clinical research associate job in Webster, TX

    Tranquil Clinical Research is enrolling clinical trials enrolling healthy human subjects. The following criteria must be met to apply: Between the ages of 18-45 years old No current medical history Healthy and free from clinically significant illness or disease, as determined by medical history, physical examination, clinical laboratory assessments, and other tests. No drug allergies No peanut allergies Not on any current medications or oral contraceptive medication Males body weight greater than 110lbs (50kg) Females Body weight greater than 99lbs (45kg) Body Mass Index (BMI) Between 19-28kg/m2 No recreational drug use within 90 days
    $34k-52k yearly est. Auto-Apply 60d+ ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Sugar Land, TX?

The average clinical research associate in Sugar Land, TX earns between $41,000 and $98,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Sugar Land, TX

$64,000
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