Clinical research coordinator jobs in College Station, TX - 417 jobs
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Physician Life Care Planning
Clinical research coordinator job in San Antonio, TX
Job Summary: ClinicalResearch Associates works under the direction of physician experts performing data research and document production activities on medical-legal cases. Duties include researching medical billing codes, conducting scientific literature reviews, sourcing cost data, analyzing medical cost/vendor surveys, and performing extensive quality control and proofreading.
About This Opportunity
The ClinicalResearch Associates begins by working within a designated pod alongside more tenured and experienced team members in higher roles. During this initial phase, the Apprentice provides research assistance on cases managed by senior staff members who carry higher caseloads. As the Apprentice gains experience and proficiency, they gradually transition to independently managing their own caseload of 7-10 active cases.
The ClinicalResearch Associates receives hands-on training in the company's proprietary Workflow and Information Management System (WIMS) while developing specialized knowledge in medical coding, cost analysis, and document production. As a downstream operations department, this role requires collaboration and communication with various departments across the organization to ensure the highest quality deliverables are completed.
This position requires the ability to work effectively in a fast-paced environment with strong multitasking skills and the ability to maintain composure and organizational clarity during high-pressure situations. Advanced Microsoft Office Suite proficiency, excellent proofreading abilities, critical thinking and problem-solving skills, attention to detail, and a firm commitment to meeting deadlines are essential. The role involves seven to eight hours per day of computer-based work, which may include prolonged sitting.
Essential Job Functions
Research & Analysis
Research medical billing codes (CPT, CDT, HCPCS, Anesthesia and MS-DRG) and assign them to medical procedures and services
Conduct scientific literature reviews and source healthcare cost data
Contact vendors to gather location-specific pricing information
Analyze medical cost surveys and perform cost calculations
Knowledge of CPT, CDT, HCPCS, Anesthesia and MS-DRG medical codes
Intermediate to Advanced knowledge of medical terminology, anatomy, physiology, and pharmacology
Case Management
Coordinate communication between internal staff and physician experts
Track case progress and keep management informed of project status
Ensure all work meets strict deadlines and quality standards
Critical thinking and problem-solving skills
Ability to thrive in a fast-paced, deadline-driven environment
Quality & Production
Perform quality control and proofread medical-legal documents
Master our proprietary Workflow and Information Management System
Apply methodological processes under physician direction
Maintain HIPAA compliance and patient confidentiality
Intermediate to advanced proficiency in Microsoft Office Suite (especially Word)
Strong grammatical and proofreading abilities
Excellent written and verbal communication skills
Typing speed of 40+ wpm
Education and Experience
Bachelor of Science in Biology and/or Chemistry, OR
Medical Billing and Coding Certification with 2+ years of professional medical office experience, OR
2+ years of professional experience in a medical office or medically-related field
Preferred Qualification
Active CBCS certification (or willingness to obtain within first year)
Strong memory recall abilities
Team-first attitude and collaborative spirit
Ability to manage multiple priorities with efficiency
Work Schedule
5 day/40-hour work week: Mon - Fri 8:30am - 5:30pm.
Overtime may be required and will be based on business needs.
Benefits
At Physician Life Care Planning, our employees enjoy benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), life insurance, paid time off program with paid holidays and various wellness programs. Additionally, our career path planning assists employees with their professional goals.
Work Environment
Physician Life Care Planning is a professional office setting. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Physician Life Care Planning's Core Values
Commitment to Excellence, Superlative Expertise, Integrity, Ownership, Professionalism, Problem-Solving and Customer Centricity.
Physician Life Care Planning is an equal opportunity employer.
Confidentiality
ClinicalResearch Associates must adhere to Federal HIPAA Regulations and willing to sign a Confidentiality Agreement.
$51k-81k yearly est. 2d ago
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Research Vocational Nurse (SIVS Operations Research - Galveston)
University of Texas Medical Branch 3.6
Clinical research coordinator job in League City, TX
Minimum Qualifications:
Graduation from a Licensed Vocational Nurse program and licensure/permit as a vocational nurse in the state of Texas. Current BLS required.
Preferred:
Research experience
Provides general nursing and administrative assistance to a research team in all aspects of clinicalresearch/trial operations and ongoing research projects, within the scope of their education and demonstrated abilities.
Job Duties:
Completes all required/assigned training in a timely manner
Conducts studies as delegated by Principal Investigator and according to the protocol and the guidelines of the FDA and other regulatory agencies.
Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
Educates potential volunteers and study participants on the details of studies
Screens, enrolls, and evaluates study subjects.
Schedules study appointments and procedures as per protocol.
Safely and properly administers investigational products research medication and FDA approved medications to research patients, under medical direction.
Maintain accurate investigational product accountability logs
In accordance with research protocols, assists with or performs the collection, processing, labeling, storage and shipping of specimens.
Collection/completion of regulatory documents and maintenance of regulatory binder
Completes source documentation and case report forms.
Distributes research information to faculty, research staff, principle investigator, and others as requested.
Operates and cares for equipment, including tracking and maintaining calibrations
Notifies appropriate nursing and medical staff of changes in patient status.
Maintains patient's privacy and confidentiality of information and records at all times.
Adheres to required infection control, isolation procedures, and aseptic techniques in the delivery of patient care.
Administrative duties including filing, entering and maintaining data, faxes, computer work, and ordering supplies.
Maintains supplies inventory by checking stock; anticipating needs; placing and expediting requests; verifying receipt.
Attends meetings, discussions and activities deemed as appropriate.
Adheres to internal controls established for department.
Performs related duties as required.
Salary Range:
Commensurate with experience. $44,880 - $67,320
EQUAL EMPLOYMENT OPPORTUNITY:
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
Compensation
$44.9k-67.3k yearly 4d ago
Clinical Research Associate II - Dallas, Texas - Phase I
Fortrea
Clinical research coordinator job in Dallas, TX
Fortrea's Clinical Pharmacology Team is hiring a CRA 2 with Phase I experience in Dallas, Texas!
WHAT YOU WILL DO
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinicalresearch standards.
Responsibilities:
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned -
Responsible for all aspects of site management as prescribed in the project plans
General On-Site Monitoring
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested
Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
Assist with training of new employees, eg. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
Perform other duties as assigned by management
Requirements
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
2+ years of Clinical Monitoring experience
Phase I experience preferred
Must reside in Dallas Texas area
The important thing for us is you are comfortable working in an environment that is:
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
Changing priorities constantly asking you to prioritize and adapt on the spot.
Teamwork and people skills are essential for the study to run smoothly.
Technology based. We collect our data directly into an electronic environment.
What do you get?
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:
Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
401(K)
Paid time off (PTO) - Flex Plan
Employee recognition awards
Multiple ERG's (employee resource groups)
Target Pay Range: $100-113K
#LI - Remote
Applications will be accepted on an ongoing basis.
Learn more about our EEO & Accommodations request here.
$100k-113k yearly Auto-Apply 11d ago
Clinical Research Associate II
Field of Talent
Clinical research coordinator job in Dallas, TX
Job Title: ClinicalResearch Associate II (Medical Device)
Work Arrangement: 1099 Consulting (Remote with 30-50% Travel)
Required Skills:
3-5 years of Medical Device clinical monitoring.
Proficiency in FDA regulations (IDE/510k) and ICH guidelines. Experience with full-cycle study conduct (selection through close-out).
Preferred Skills:
CRA Certification (CCRA via SOCRA or ACRP).
Neurology therapeutic experience.
Employer Value Proposition: Join a well-funded startup in a high-impact role. Influence product readiness through direct collaboration with R&D and Regulatory Affairs while enjoying the autonomy of a remote, flexible consulting arrangement.
Job Description:
As a ClinicalResearch Associate with the company, you are the guardian of data integrity for life-changing medical technology. You aren't just a monitor; you are the eyes and ears of a specialized clinical program. You'll spend your days building vital relationships with investigators, ensuring every data point is bulletproof, and collaborating directly with R&D and Regulatory teams to move innovative neurology devices from the lab to the patients who need them most.
Why This Role is Different:
Total Project Ownership: Manage the full study lifecycle-from site selection to close-out-within a high-visibility startup environment.
Strategic Impact: Influence the company's future by contributing directly to IDE and 510(k) regulatory submissions.
True Autonomy: Manage your own travel schedule and remote workspace while overseeing a well-funded clinical program.
Your Mission: You will ensure every facet of our studies meets the highest standards of quality. Your focus is on the "big picture" of study success:
Site Management: Drive day-to-day execution and conduct visits to ensure protocol adherence and patient safety.
Data Integrity: Meticulously review source documentation and CRFs to ensure every data point is audit-ready.
Collaboration: Act as the vital link between external investigators and our internal R&D and Regulatory departments.
Qualifications: We are looking for a professional with a Bachelor's degree in a scientific field,
3-5 years of medical device monitoring experience
, and a deep understanding of
FDA/ICH guidelines
. If you are a highly organized communicator ready for 30-50% travel, we want to hear from you.
$48k-76k yearly est. 11d ago
Clinical Research Associate 1
Allen Spolden
Clinical research coordinator job in Texas
Responsible for providing ClinicalResearch support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinicalresearch functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1 -2 years of clinicalresearch experience or equivalent experience or training
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
$50k-78k yearly est. 60d+ ago
Research Scientist II - Health and Clinical Outcomes Research
Aa083
Clinical research coordinator job in Galveston, TX
Research Scientist II - Health and Clinical Outcomes Research - (2506239) Description DEPT MARKETING STATEMENT:UTMB's new Center for Health and Clinical Outcomes Research (H-COR) seeks Research Scientists to advance decision-grade evidence from real-world data to study and understand human health.
H-COR leverages Epic EHR (Clarity/Caboodle and Cosmos), TriNetX, Medicare and other administrative data.
H-COR has an interest in pairing outcomes research with secure, principled integration of high-dimensional modalities (e.
g.
, transcriptomics, proteomics, pathogen genomics).
Also of interest is the utilization of novel data sources including those derived from social media, mobile phones, wearables, and other digital sources.
Researchers at H-COR collaborate across all five UTMB schools JOB DESCRIPTION: Conducts innovative scientific investigation by developing theories and devising scientific methods and procedures to apply scientific principles, theories and research in projects related to the mission of UTMB.
Committed to the discovery of new innovative biomedical and health services knowledge leading to increasingly effective and accessible health care.
Assures competence as a fully trained scientist in a specific discipline or area of expertise.
ESSENTIAL JOB FUNCTIONS:Leading and contributing to high-impact health and clinical outcomes research Planning and performing advanced data analyses using UTMB's exceptional data infrastructure, with particular emphasis on electronic health record (EHR) data including EPIC, EPIC Cosmos, TriNetX, and Medicare administrative datasets Building transparent cohort definitions and phenotypes using ICD-10/PCS, CPT/HCPCS, LOINC, and RxNormImplementing modern causal-inference strategies (e.
g.
, target-trial emulation, robust confounding control, time-to-event and longitudinal models, principled handling of missingness, falsification and sensitivity analyses) Collaborating across UTMB's schools on defined research programs Contributing to abstracts, manuscripts, and grant applications as PI/Co-I or key personnel Integrating clinical timelines with multi-omics and other high-dimensional data while preserving clinical interpretability and privacy Presenting research at professional meetings and conferences Participating in H-COR's monthly works-in-progress seminars MINIMUM QUALIFICATIONS:Ph.
D, M.
D, D.
O.
, or D.
V.
M in related field and one year of related experience.
PREFERRED QUALIFICATIONS: PhD or equivalent doctoral degree in a relevant discipline (health services research, epidemiology, biostatistics, data science, computer science, or a closely related field) A track record in health and clinical outcomes methods Demonstrated expertise analyzing clinical and population-health data with specific experience in EHR analytics Proficiency with large healthcare databases (Epic, Epic Cosmos, TriNetX, Medicare) Fluency in at least two of R, Python, SAS, and SQL Excellent scientific writing and communication Evidence of peer-reviewed publications commensurate with career stage Experience with OMOP and HL7 FHIR data models Hands-on practice with target-trial emulation and advanced propensity and longitudinal methods Clinically oriented NLP and time-aware feature extraction Familiarity with multi-omics data structures and cautious EHR-omics linkage Experience in HPC or cloud settings (e.
g.
, TACC, Azure, AWS) and workflow engines that promote end-to-end reproducibility Mentorship of analysts or trainees A record of effective, cross-disciplinary collaboration in an academic health-sciences environment SALARY:Commensurate with experience.
Qualifications EQUAL EMPLOYMENT OPPORTUNITY:UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law.
As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.
Primary Location: United States-Texas-GalvestonWork Locations: 1150 - UTMB HEALTH CLINICS 301 University Blvd.
UTMB Health Clinics, rm 4.
208 Galveston 77555-1150Job: Research Academic & ClinicalOrganization: UTMB Health: RegularShift: StandardEmployee Status: ManagerJob Level: Day ShiftJob Posting: Jan 6, 2026, 10:18:47 PM
$54k-90k yearly est. Auto-Apply 12d ago
Clinical Study Coordinator
Tranquil Clinical and Research Consulting Services
Clinical research coordinator 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
Senior Clinical Research Coordinator
Alliance Clinical
Clinical research coordinator job in Irving, TX
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations.
Manage, train and support clinical site staff.
Review, comprehend and communicate study protocols.
Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV).
Assist CRC team as requested to facilitate research and business needs.
Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP's.
Ensure all data is entered into sponsor's data portal and all queries are resolved in a timely manner.
Work closely with CRO/CRA and IRB.
Perform administrative tasks such as ordering supplies and equipment for the study.
Manage all required study start up documentation, training and timelines on assigned study protocols.
QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPREIENCE:
Associate's degree and/or completion of accredited healthcare certification program, required.
Comfortable stepping into a leadership role.
4+ years' experience in clinicalresearch, required.
4+ years' experience working as a ClinicalResearchCoordinator, preferred.
Comprehensive knowledge of FDA, GCP & confidentiality.
Exceptional attention to detail and organization.
Excellent written and communication skills.
A proven ability to multi-task in a rapidly changing environment.
WORK LOCATION: Irving, Texas
TRAVEL INVOLVED: 60%
BENEFITS:
401 (k) Retirement Plan
Medical, Dental, and Vision Insurance
Paid Time Off (PTO)
Floating Holidays
And more!
$42k-64k yearly est. Auto-Apply 60d+ ago
Clinical Research Coordinator II
Care Access 4.3
Clinical research coordinator job in Tyler, 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 to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch 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 ClinicalResearchCoordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Patient Coordination
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Maintain effective relationships with study participants and other care Access Research personnel.
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.
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)
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.
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
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)
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 3 years prior ClinicalResearchCoordinator experience required
Prefer 1 year of experience as a Care Access ResearchClinicalResearchCoordinator
Recent phlebotomy experience required
Licenses:
California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health
Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners
Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health
Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health
How We Work Together
Location: This is an on-site position with regional commute requirements, located in Tyler, Texas
Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives.
Type of travel required: Regional (within 100 miles)
Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Walking - 20%
Standing - 20%
Sitting - 20%
Lifting - 20%
Up to 25lbs
Over 25lbs Overhead
Driving - 20%
The expected salary range for this role is $60,000 - $90,000 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: ********************************
$60k-90k yearly Auto-Apply 9d ago
Study Coordinator ll
Johnson County Clintrials
Clinical research coordinator 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 clinicalresearch (CFR, GCP, HIPAA)
Minimum 3 years of experience coordinatingclinical 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 clinicalresearch 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 clinicalresearch 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
Social Studies Coordinator
Del Valle ISD (Tx 3.5
Clinical research coordinator job in Austin, TX
Primary Purpose: Provide leadership and coordination to align and articulate instructional programing in the area of Social Studies. Minimum Qualifications: Education/Certification: Master's degree preferred from accredited university with a major in assigned subject or closely related field
Valid Texas teaching certificate in Social Studies field
Candidate must have satisfactory outcome of fingerprinting background check. Non-refundable fee (approximately $50.00) paid by employee.
Required Experience:
Minimum of three (3) years' teaching experience in subject area assigned
Administrative and/or leadership experience
Knowledge/Skills:
Knowledge of curriculum design and implementation
Ability to evaluate instruction programs and teaching effectiveness
Ability to develop and deliver training to adult learners
Ability to interpret data
Strong organizational, communication, and interpersonal skills
Major Responsibilities and Duties:
(The following statements describe the general purpose and responsibilities assigned and should not be construed as an exhaustive list of all responsibilities, skills, efforts, or working conditions that may be assigned or skills that may be required.)
Professionalism
The Educators' Code of Ethics is set forth in Texas Administrative Code to provide rules for standard practices and ethical conduct toward students, professional colleagues, school officials, parents, and members of the community.
* Rule §247.1 Purpose and Scope; Definitions
* Rule §247.2 Code of Ethics and Standard Practices for Texas Educators
Instructional Management
The coordinator promotes improvement of instruction through activities such as the following:
* Coordinate the review, development, and revision of all subject area programs and related curriculum documents and materials, including curriculum guides, course outlines, and teaching plans.
* Work with directors, coordinators, campus administrators, grade level leaders, department chairs, and teachers to effectively use technology, reading strategies, writing strategies, and personalized strategies for special needs and Emergent Bilingual students in Social Studies.
* Work cooperatively with directors and campus principals in developing and supervising the instructional programs in assigned subject area.
* Work with teachers to plan, improve, and oversee assessment programs for the assigned subject area.
* Support teachers, administrators, and staff in understanding the relationship between assessment and instruction.
* Coordinate the ordering and use of materials for assigned subject.
* Obtain and use evaluative findings (including student achievement data) to examine curriculum and instruction program effectiveness for the designed subject area.
* Maintain a staff library of publications, supplementary materials, and supplies relevant to the designated subject area.
* Assist in the preparation of the budget and administration of the budget for supplies, equipment, and facilities in the designated subject area.
Organization Improvement
The coordinator promotes leadership in efforts to improve the school or organization through activities such as the following:
* Ensure teaching of all grade-level TEKS in the designated subject area.
* Ensure assessment of all grade-level TEKS in the designated subject area.
* Ensure alignment of assessments and instruction across all grade levels in the designated subject area.
* Submit all required data from designed subject areas to the state.
* Keep informed of and comply with state, district, and school regulations and policies.
Communication and Community Relations
The coordinator promotes a positive tone for school or community relations through activities such as the following:
* Coordinate with subject and special program leaders to provide staff development, cross-curricular teaching strategies, and demonstration lessons.
* Coordinate with intervention, special education, and multilingual personnel to support research-based practices in the designated subject area across all classrooms.
* Use effective communication skills to present information accurately and clearly.
* Provide support to teachers in conducting parent trainings in the designated subject area.
* Assist in communication information to parent and community members about school programs.
* Coordinate with community groups to provide parent support and training in the designated subject area.
* Participate in national and state level organizations to stay abreast of latest research and best practices.
* Attend professional development opportunities related to designated subject area.
* Read, synthesize, and disseminate research and information related to best practices from books, journals, list-serves, Website, and other media formats.
Organization Management
The coordinator manages administrative, fiscal, and facilities functions responsibly through activities such as the following:
* Oversee benchmark and district assessments in the designated subject area.
* Analyze and report all data from benchmark and district assessments in the designated subject area.
* Use all data analyses to plan ongoing and training for teachers, administrators, and staff in the designated subject area.
* Train teachers, administrators, and staff in data analysis of all assessments in the designated subject area.
* Provide support in connecting all data analyses to instructional practices in the designated subject.
* Manage grants and other projects with entities outside the district, including universities and nonprofits.
* Manage materials from vendors and on server to support teacher implementation of best practices.
* Compile, maintain, and file all physical and computerized reports, records, and other documents.
Professional Growth and Development
The coordinator provides leadership in professional growth and development through activities such as the following:
* Plan and provide staff development for teachers, administrators, and staff in the designed subject area.
* Organize and manage professional development by outside entities, including university projects, regional service providers, and vendors.
* Disseminate information regarding current research and significant developments on the state and national service providers, and vendors.
* Disseminate specific lesson ideas with related materials to be implemented across classrooms.
* Observe classroom instruction and provide feedback and assistance to classroom teachers to facilitate improvement and innovation.
* Demonstrate effective instructional practices with students in the classroom.
* Meet with teachers and administrators regularly to examine data, discuss instruction, and provide feedback related to in-class observations.
* Meet with identified teachers in the designated subject area to provide intensive training and support.
Qualities of an Effective Coordinator
The coordinator exhibits the following qualities:
* Daily attendance and punctuality at work are essential functions of the job.
* Comply with district and campus policies and procedures, as well as state and federal laws and regulations.
* Comply with the standards of conduct set out in Board Policy DH (Legal) and (Local) and with any other policies, regulations, and guidelines that impose duties, requirements, or standards.
* Demonstrate a high level of personal integrity, a collaborative leadership style, and high ethical standards.
* Keep informed of and comply with state, district, and campus policies affecting schools.
* Compile, maintain and file all reports, records, and other required documents.
* Maintain confidentiality.
Supervisory Responsibilities:
* None
Equipment:
Computer, computer software programs and peripherals, teacher resource materials and equipment, printer, copier, fax and other equipment applicable to the position.
Working Conditions:
Mental Demands/Physical Demands/Environmental Factors:
* Work irregular and extended work hours to include holidays and weekends.
* May report to various campuses within the district for a full work day.
* Work with frequent interruptions and maintain emotional control under stress.
* Continual standing, walking, lifting, carrying, stooping, bending, and kneeling.
* Limited exposure to hot and cold temperatures.
* Frequent exposure to: temperature extremes (hot and cold), humidity extremes, noise, low or intense illumination vibration. Occasional exposure to: biological hazards (communicable diseases, bacteria, insects, mold, fungi, etc.), work outside, work around moving objects or vehicles, work on uneven surfaces.
The foregoing statements describe the general purpose and responsibilities assigned to this job and are not an exhaustive list of all responsibilities and duties that may be assigned or skills that may be required.
The grantee certifies that the federally funded portion of this position and duties are reasonable, necessary, allowable and allocable under the applicable federal fund source. The grantee further certifies that it is in compliance with the federal requirement that the duties of this position funded by this grant are not required by state law, SBOE rules, or local board policy, i.e., it is a supplemental position. The grant-funded portion of this position and duties meet the purpose, goals, and objectives of the federal fund source. Documentation will be maintained locally by the district that clearly demonstrates the allowable and supplemental nature of the position and will provide such documentation to TEA upon request. The LEA will maintain auditable documentation to ensure the position was determined through a needs assessment and is included in the campus improvement plan and district improvement plan.
$35k-47k yearly est. 11d ago
Clinical Trial Screening Coordinator
DM Clinical Research
Clinical research coordinator job in Texas
Clinical Trial Screening Coordinator The Clinical Trial Screening Coordinator will act as a liaison between the recruitment and clinical trials teams to ensure that potential trial subjects are assigned to the trial best suited for them. To ensure that subjects have the required paperwork, medical records, and authorizations to participate in trials. To demonstrate effective knowledge of protocols, including inclusion/exclusion criteria. To demonstrate knowledge of Good Clinical Practices and FDA regulations specifically pertaining to the recruitment and retention of study subjects.
DUTIES & RESPONSIBILITIES
Completing DMCR-required training, including GCP and NIH.
Ensuring all patient enrollment activities are performed as per clinical trial protocol parameters by engaging directly with the CRCs and working closely with the clinical trial team.
Interfacing with potential research subjects to recruit, assess eligibility criteria, determine subject availability, assist investigators with obtaining informed consent and coordinate appointments with the recruitment team.
Managing pre-screen operational activities and establishing strong relationships with clinical trial sites and the staff.
Accountable for coordinating pre-screen data management activities - performing quality checks on timely data entry and data quality in the clinicalresearch electronic system (CRIO).
Ensuring availability of study participant's information by accurately filing and/or retrieving study participant records as requested by management
Being prepared for and available at all required company meetings.
Submitting administrative paperwork per company timelines.
Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE
Education:
FMG (Foreign Medical Graduate) preferred or
Bachelors in Health Care Sciences or
Nursing Degree- LVN, LPN, or RN
Experience:
3-4 years of Medical terminology
1-2 years of customer service experience
1-2 years of clinicalresearch experience preferred
Credentials:
N/A
Knowledge and Skills:
Dependability
Medical Spanish a plus
Be an energetic, go-getter who is detail-oriented and can multi-task.
Be goals-driven while continuously maintaining quality.
Have attention to detail and accuracy.
Extreme attention to detail (strict adherence to procedures and protocols is essential)
Good knowledge of Good Clinical Practices and FDA regulations, protocols
Ability to use computer applications for data capture and for general communication required to
Communicate effectively, both orally and in writing
$34k-52k yearly est. 60d+ ago
Clinical Research Coordinator San Antonio
U.S. Renal Care, Inc. 4.7
Clinical research coordinator job in San Antonio, TX
The ClinicalResearchCoordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinicalresearch is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. ClinicalResearchCoordinator (SCRC), the clinical site, sponsor(s), clinicalresearch organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of ClinicalResearch.
Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
Assists in the coordination of efforts of internal and external resources (industry partners, clinicalresearch organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
Adheres to the USRC Research quality assurance program guidelines.
Travel to Investigator Meetings or similar research related meetings is required.
Travel may be required between dialysis facilities or nephrology practices within the community.
Develops a working knowledge of current clinicalresearch practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
May provide training and oversight of ClinicalResearchCoordinators and/or Research Assistants.
Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
Participate in staff meetings as required.
Regular and reliable attendance is required for the job.
Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
Regular and reliable attendance is required for the job.
$44k-62k yearly est. 1d ago
Research Nurse Coordinator
Texas A&M Agrilife Research
Clinical research coordinator job in College Station, TX
Job Title Research Nurse Coordinator Agency Texas A&M Agrilife Research Department Food Science & Technology Proposed Minimum Salary $40.00 hourly Job Type Staff Job Description The Research Nurse Coordinator, under general supervision, supervises and coordinates personnel and facilitates research projects. Assists with the selection, enrollment, education, testing, data entry, and monitoring of research project subjects. Provides nursing care to research subjects enrolled in studies.
Responsibilities:
* Manages subjects involved in research projects and blood work.
* Coordinates personnel, facilities, and subject recruitment for multiple projects.
* Oversees technical aspects of functional research experiments and administrative functions of clinicalresearch studies.
* Implements, manages, and analyzes study protocols concerning research on Post-Traumatic Stress Disorder (PTSD) and mental health issues.
* Maintains and oversees database for research.
* Performs administrative duties including writing, filing, data entry, and setting appointments.
* Other duties as required.
Required Education and Experience:
* Bachelor's degree in Nursing or equivalent combination of education and experience.
* Two years of related experience in clinicalresearch.
Required Knowledge, Skills and Abilities:
* Knowledge of word processing and spreadsheet applications.
* Knowledge of research project administration and general nursing procedures.
* Ability to multitask and work cooperatively with others.
* Strong verbal and written communication skills.
* Effective interpersonal and organizational skills.
Required Registrations, Certifications, and Licenses:
Licensed Nurse, Certified phlebotomist, and CPR certified.
All positions are security-sensitive. Applicants are subject to a criminal history investigation, and employment is contingent upon the institution's verification of credentials and/or other information required by the institution's procedures, including the completion of the criminal history check.
Equal Opportunity/Veterans/Disability Employer.
$40 hourly Auto-Apply 60d+ ago
Research Nurse Coordinator
Texas A&M Agrilife Extension Service
Clinical research coordinator job in College Station, TX
Job Title
Research Nurse Coordinator
Agency
Texas A&M Agrilife Research
Department
Food Science & Technology
Proposed Minimum Salary
$40.00 hourly
Job Type
Staff
Job Description
The Research Nurse Coordinator, under general supervision, supervises and coordinates personnel and facilitates research projects. Assists with the selection, enrollment, education, testing, data entry, and monitoring of research project subjects. Provides nursing care to research subjects enrolled in studies.
Responsibilities:
-Manages subjects involved in research projects and blood work.
-Coordinates personnel, facilities, and subject recruitment for multiple projects.
-Oversees technical aspects of functional research experiments and administrative functions of clinicalresearch studies.
-Implements, manages, and analyzes study protocols concerning research on Post-Traumatic Stress Disorder (PTSD) and mental health issues.
-Maintains and oversees database for research.
-Performs administrative duties including writing, filing, data entry, and setting appointments.
-Other duties as required.
Required Education and Experience:
-Bachelor's degree in Nursing or equivalent combination of education and experience.
-Two years of related experience in clinicalresearch.
Required Knowledge, Skills and Abilities:
-Knowledge of word processing and spreadsheet applications.
-Knowledge of research project administration and general nursing procedures.
-Ability to multitask and work cooperatively with others.
-Strong verbal and written communication skills.
-Effective interpersonal and organizational skills.
Required Registrations, Certifications, and Licenses:
Licensed Nurse, Certified phlebotomist, and CPR certified.
All positions are security-sensitive. Applicants are subject to a criminal history investigation, and employment is contingent upon the institution's verification of credentials and/or other information required by the institution's procedures, including the completion of the criminal history check.
Equal Opportunity/Veterans/Disability Employer.
$40 hourly Auto-Apply 60d+ ago
Clinical Research Coordinator I
SGS Group 4.8
Clinical research coordinator job in Richardson, TX
We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
Responsibilities include but are not limited to being lead coordinator on a study, executing follow-up visits ongoing studies, query resolution and other study specific tasks. The CRC I will perform daily tasks such as document review, data entry, test material preparation and data collection. This position may coordinate and execute projects assigned by the Clinic Manager while abiding by Good Clinical Practice (GCP) guidelines.
JOB FUNCTIONS
* Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information
* Responds to queries from Quality Assurance and Statistics departments
* Sets up and conducts study in compliance with protocol, SOPs, applicable regulations and GCPs
* Prepares for and conducts pre-study meetings as well as other meetings and processes as deemed to protocol, SOPs and GCPs
* Monitor Compliance of panelists
* Prepares and is accountable for all Test Material for managed studies
* Adheres to study budget
* Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents
* Assures that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs
* Coordinates scheduling subjects for visits
* Completes other duties or tasks assigned by Clinic Manager and/or Supervisor
JOB COMPLEXITY
* Multi-tasking is key
IMPACT OF DECISIONS
* Make decisions as a study leader
ANALYTICAL THINKING/PROBLEM SOLVING
* Handle issues with panelists and create solutions
* Arrange work for studies
Qualifications
EDUCATION AND EXPERIENCE
* Associate degree or 2 years minimum of relevant work experience with a GED or High School Diploma.
* Understands basic concepts in clinicalresearch and capable of learning and performing duties during clinical studies
KNOWLEDGE / SKILLS / ABILITIES
* Language Skills
* Mathematical Skills
* Reasoning Skills/Abilities
* Computer Skills
* Ability to manage and coordinate multiple projects in a fastpaced, highly professional environment.
Additional Information
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.
$41k-60k yearly est. 9d ago
Clinical Research Coordinator I
Objectivehealth 3.7
Clinical research coordinator job in Wichita Falls, TX
Our clinicalresearch company is looking to hire a qualified candidate for the full-time position of ClinicalResearchCoordinator. The ideal candidate will possess certification such as an MA, phlebotomy, or similar and have a strong desire to work directly with patients.
Who We Are
ObjectiveHealth is a clinicalresearch company that uses proprietary technology to:
* Increase patient access to research trials within our communities,
* Provide physicians with enhanced care options for current patients, and
* Deliver superior clinicalresearch enrollment metrics to Pharma sponsors
All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that.
Who You Are
* A lover of patient interaction and skilled at providing patient care
* A team player with a bias for action and an attitude that takes personal responsibility
* Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc.
* Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc.
* Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence
* An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others
* A strong advocate for Company values, mission, and initiatives
* Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies
* Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology
What Success Looks Like for This Role
* Taking ownership of assigned studies and patients
* Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction
* Showing up on time, every time
* Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies
* Learning and using the technologies we provide to increase efficiency in your day-to-day activities
* Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication
What We Offer
Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.
Requirements
This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.
$41k-59k yearly est. 38d ago
Study participant - US (CST)
Prolific 4.2
Clinical research coordinator job in Austin, TX
Study Participants
Prolific is not just another research platform - we are building the biggest pool of quality human research data in the world.
Over 35,000 researchers, educators, and organizations use Prolific to run studies with paid participants who bring a wide variety of experiences, knowledge, and skills.
The role
We're looking for Study Participants to take part in academic and applied research studies for global businesses and educational faculties. If you have the necessary experience, we'll send you a quick 10- to 15-minute screening to assess your suitability for research studies. If successful, you'll be invited to join Prolific as a participant, where you'll get paid to contribute to a wide range of studies and research projects.
Researchers looking for your profile tend to pay up to $18/hr per study completed. You must be prepared to complete paid studies that require one hour of uninterrupted work, though many are shorter.
What you'll bring
A track record of relevant experience, knowledge, or lived context that may be valuable to researchers (as applicable)
A willingness to take our screening to assess your suitability for our participant pool
Strong attention to detail and the ability to concentrate on research tasks for up to one hour at a time
A reliable and fast internet connection and access to a computer
A willingness to self-declare your earnings, as our participants are self-employed
A Paypal account to receive payment from our clients
What you'll be doing in the role
Completing paid research studies such as answering surveys, participating in experiments, and providing written responses
Providing feedback, judgements, and opinions in structured research tasks
Contributing to high-quality research outcomes by responding thoughtfully and accurately
Key study types
Surveys and Questionnaires
Behavioural Experiments
User Research and Product Feedback
Educational and Academic Studies
Interviews and Open-Ended Responses
Quality Checks and Attention Tasks
Why Prolific is a great platform to join as a Participant
Joining our platform as a Prolific participant will give you the chance to contribute to meaningful research used by universities, researchers, and global organizations. Once you pass our screening, you can join Prolific in just 15 minutes, and start enjoying competitive pay rates, flexible hours, and the ability to work from home.
We've built a unique platform that connects researchers and organizations with a global pool of participants, enabling the collection of high-quality, ethically sourced human behavioural data and feedback. This data helps researchers answer important questions, improve products and services, and advance knowledge across disciplines.
We believe that the best research outcomes come from diverse human perspectives and experiences. By providing this crucial human data infrastructure, Prolific is positioning itself at the forefront of the next wave of research innovation - one that reflects the breadth and the best of humanity.
Links to more information on Prolific
Website
Youtube
Privacy Statement
By submitting your application, you agree that Prolific may collect your personal data for recruiting and global organisation planning. Prolific's Candidate Privacy Notice explains what personal information Prolific may process, where Prolific may process your personal information, its purposes for processing your personal information, and the rights you can exercise over Prolific use of your personal personal information.
$18 hourly Auto-Apply 9d ago
Clinical Research Coordinator - Temporary Assignment
M3 Global Research 4.2
Clinical research coordinator job in Tye, TX
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinicalresearch needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinicalresearch organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinicalresearch companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring for a temporary ClinicalResearchCoordinator at Wake Research, an M3 company. This is an on-site position at our Dallas, TX site. This assignment will last between 2-4 months.
A ClinicalResearchCoordinator (temporary) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial.
Essential services to be performed:
* Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses.
* Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management.
* Coordinates with site management/PI to help ensure that clinicalresearch protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures.
* Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria.
* Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials.
* Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc.
* In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed.
* Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents.
* Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review.
* Assists with timely completion of case report forms, if appropriately delegated/trained.
* Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability.
* Assists fellow co-workers with studies as time and ability permits.
Qualifications
* Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.
* Successful completion of the GCP certification.
* Phlebotomy and EKG experience.
* +2 years of CRC experience is preferred.
* Bilingual - Spanish preferred.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
* M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Onsite
#LI-LB1
$42k-56k yearly est. 1d ago
Clinical Research Associate - Oncology - West Region (Denver, PHX, LA or San Fran)
Icon Plc 4.8
Clinical research coordinator job in Colorado City, TX
ClinicalResearch Associate - Oncology - West Region (AZ, CO, CA) ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What You Will Be Doing:
* Serve as the primary point of contact between investigational sites and the sponsor
* Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
* Ensure site compliance with ICH-GCP, SOPs, and regulations
* Maintain up-to-date documentation in CTMS and eTMF systems
* Support and track site staff training and maintain compliance records
* Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
* Support subject recruitment and retention efforts at the site level
* Oversee drug accountability and ensure proper storage, return, or destruction
* Resolve data queries and drive timely, high-quality data entry
* Document site progress and escalate risks or issues to the clinical team
* Assist in tracking site budgets and ensuring timely site payments (as applicable)
* Collaborate with cross-functional partners including CTAs, LTMs, and CTMs
You are:
* A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN
* Eligible to work in United States without visa sponsorship
* A clinicalresearch professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
* Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology
* Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
* A clear communicator, problem-solver, and collaborative team player
* Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in the West region (Phoenix, AZ, Denver, CO, Los Angeles or San Francisco, CA) near major HUB airports to support efficient regional travel
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$48k-69k yearly est. 5d ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in College Station, TX?
The average clinical research coordinator in College Station, TX earns between $32,000 and $67,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in College Station, TX