Clinical Research Site Manager
Clinical research coordinator job in Plano, TX
ACRC Trials, with headquarters in Plano, TX and locations in Carrollton, Frisco, Grapevine & Plano, conducts clinical trials with award-winning physicians. Our doctors are consistently recognized by their peers as D Magazine's "Best Doctors." Our dedicated team provides convenient, accessible, and high-quality patient care. We aim to advance medical knowledge and introduce new and improved medications through pharmaceutical-sponsored clinical research trials. We are committed to the highest ethical standards and safety in all our clinical practices.
Role Description
This is a full-time ON-SITE role for a Clinical Research Site Manager, located in Plano, TX, with travel to surrounding sites, as required. The Clinical Research Site Manager will oversee the daily operations of clinical trials, ensure adherence to protocols, and maintain regulatory compliance. Responsibilities include coordinating with physicians and research nurses, managing project timelines, overseeing patient recruitment and retention, and ensuring data integrity. The role also involves liaising with sponsors, monitoring study progress, and reporting findings.
Qualifications
Must have prior experience managing 2 research sites or more
Proficiency in Protocol, Clinical Operations, and Clinical Trials
Experience in Research and Clinical Operations
Strong Project Management skills
Excellent organizational and communication skills
Ability to work collaboratively with cross-functional teams
Experience in the healthcare or clinical research industry is a plus
Bachelor's degree in a relevant field; advanced degree preferred
Note: Applicants must be authorized to work in the United States for any employer. At this time, we are unable to sponsor or assume sponsorship of employment visas.
Clinical Research Coordinator
Clinical research coordinator job in Dallas, TX
Clinical Research Coordinator (CRC)
Key responsibilities typically include:
Screening and recruiting study participants, verifying eligibility per protocol.
Conducting informed consent discussions and ensuring ethical treatment of participants.
Coordinating study visits, executing protocol-specified procedures (labs, vitals, diaries, adverse event monitoring, etc.).
Monitoring adverse events (AEs) and serious adverse events (SAEs), ensuring timely reporting to sponsors/IRBs.
Entering data into electronic systems (EDC/CTMS), maintaining source documentation, case report forms (CRFs) and regulatory files.
Interacting with sponsors/CROs, coordinating with study monitors, handling queries and managing trial logistics.
Ensuring compliance with Good Clinical Practice (GCP), institutional policies and regulatory requirements.
Often serving as the participant-facing point of contact and maintaining excellent communication and engagement with subjects and site staff.
Why the role matters:
The CRC ensures that the research is conducted ethically, safely, according to protocol, and produces high-quality data.
They maintain the interface between participants, clinical staff, sponsors/CROs and regulatory oversight - which is critical for successful trial execution.
Because they manage many moving parts (visits, documentation, labs, data, adverse events), strong organisational, communication and multitasking skills are essential.
Senior Clinical Coordinator
Clinical research coordinator job in San Antonio, TX
/RESPONSIBILITIES
The Senior Clinical Research Coordinator leads the evaluation of research protocols and provides clinical and risk assessment expertise on research-related procedures. Assists Director in implementation of human subject research protection program. Reviews complex human subject research protocols and supports the Clinical Research Department through coordination, monitoring, and education of processes required for Research Proposals within University Health. Represents the department at multi-institutional committees and meetings, such as IRB and OHRP.
EDUCATION/EXPERIENCE
Graduation from an accredited college or university with a Bachelor's of Science in Nursing. May substitute 8 years of related experience and licensure for required education. Master's degree preferred. A minimum of three years Research experience required. Possesses or qualifies to obtain within 6 months of employment a Clinical Research Certification (i.e. CCRP or CCRA). Has a working knowledge of research methods and knowledge of federal legislation regarding human subject research is required. Expertise in applying for research protocols, budgeting, program planning and evaluation is preferred. Exercises mature judgment and discretion in any confidential or sensitive matters.
Weights and Research Coordinator
Clinical research coordinator job in Sanger, TX
Weights and Research Coordinator, $60,000 - $65,000
Full-Time Monday-Friday, Various shifts
Come and experience the difference with R+L Carriers
Earn 1 week of vacation after 90 days of employment
Requirements:
Any type of LTL experience preferred but not required
Ability to self-motivate and self-manage
Willingness to learn
Analytical skills
Computer proficiency
Able to work in a fast-paced environment
Excellent Benefits
R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC.
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Auto-ApplyClinical Research Associate 1
Clinical research coordinator job in Texas
Responsible for providing Clinical Research 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 clinical research 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 clinical research 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
Clinical Research Associate
Clinical research coordinator job in Addison, TX
The Clinical Research Associate (Monitor) is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required. Responsibilities:
Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits and site initiation visits to ensure applicability of sites for planned study according to application regulatory requirements.
Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements.
Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent and support Institutional Review Board (IRB) submissions.
Train site staff on protocol requirements, source documentation, and case report form completion.
Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.
Conduct clinical study site close-out visits and ensure site files are complete, accurate and up to date.
File site related documents real-time to ensure Trial Master Files are complete and accurate at all times.
Provide study specific information and support report validation activities as requested for clinical study reports.
Participates in team meetings and document meeting minutes and tracks action items.
Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
Performs other duties as required (note, all listed tasks may not be conducted depending on study status and roles of other internal and external team members).
Education and Experience:
B.S. Or B.A. And/or an equivalent combination of education or experience.
Minimum of 3 years of experience directly related to the execution of clinical research studies.
Available to travel (up to 60%) on short notice and independently manage travel schedules.
Must have analytical skills, be detail oriented and have good interpersonal skills.
Knowledge of agency guidelines and requirements.
Skills/ Competencies:
Effective written and verbal communication skills.
Ability to communicate at all levels of an organization.
PC skills;word processing, spreadsheet, database, Internet search and utilization.
Flexible and able to work in a fast-paced environment.
Team player.
Ability to organize and judge priorities.
Excellent ability to generate and maintain accurate records.
Start Date - End Date: Jan 5 -Oct 3, 2026
Clinical Study Coordinator
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.
Auto-ApplyStudy Coordinator ll
Clinical research coordinator job in Houston, TX
Job DescriptionDescription:
Study Coordinator II
Department: Study Management
Purpose:
The Study Coordinator position is responsible for the coordination and administration of clinical studies under the direction of the Site Director, and the Principal Investigator.
Position Summary:
The Study Coordinator will perform diverse administrative duties requiring analysis, sound judgment and a high level of knowledge of study specific protocols. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. This position reports to the Site Manager or Site Director.
Key Responsibilities (Essential Functions):
Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities.
Manage multiple concurrent trials
Assist with mentoring and training study team members
Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates
Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information.
Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits.
Professional communication and collaborative work ethics with CRAs at Site visits.
Order and track supplies or devices necessary for study completion.
Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes.
Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies.
Track enrollment status of volunteers and documentation in Clinical Conductor system.
Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc.
Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
Collect, process and ship laboratory specimens
Adherent to safety and privacy regulations
Key Responsibilities may vary depending on work location
Experience and Skills:
Excellent communication, interpersonal, analytical and problem-solving skills
Microsoft Office Suite proficiency
Writing and verbal communication skills
Knowledge of medical terminology and concepts
Proficient typing and data entry skills
Strong study documentation skills in compliance with ALCOA+ preferred
Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred
Ability to work effectively with a team
Ability to manage small projects personally and work independently
Ability to prioritize and manage multiple projects simultaneously
Time management skills
Organizational skills
Detail oriented with the ability to perform at a high level of accuracy
Demonstrates strong critical thinking, problem solving skills
Self-motivated
Must be results oriented, multi-tasking, quick learner
Respond to the urgent needs of the team and show a strong track record of meeting deadlines
Special Requirements:
Must be fluent in speaking and understanding Spanish and English
Foreign Medical Graduate or Medical Assistant with extensive medical knowledge and training
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
Ability to lift and/or move up to 20 pounds
Education and Experience:
BS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
Minimum 3 years of experience coordinating clinical trials, including the activities listed above
Previous nursing, medical assistant experience in a clinical setting a plus
CCRC certification a plus
Demonstrated relationship building, with strong verbal and written skills.
Ability to successfully coordinate protocols with overlapping timelines
Ability to explain importance of GCP guidelines and their application
Ability to train others on coordinating responsibilities and protocol adherence
Able to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting
Strong interpersonal skills with attention to detail a must
Proven ethical and professional codes of conduct
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems.
The above is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organization and the overall business objectives of the organization.
Why JCCT?
JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.
We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.
Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.
If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!
EEO
JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Requirements:
Clinical Study Coordinator
Clinical research coordinator job in Waco, TX
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
The Clinical Study Coordinator carries out assigned tasks associated with the collection, documentation, and maintenance of clinical data. Work closely with Clinical Research Coordinators and assist them in the conduct of the clinical research protocols.
Responsibilities
Duties/Responsibilities:
Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs
Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors
Apply good documentation practices when collecting and correcting data, transferring data tosponsor/CRO data capture systems and resolving queries
Maintain confidentiality of patient protected health information, sponsor confidentialinformation and Velocity confidential information
Assist in ensuring patient safety is upheld and all adverse events, serious adverse events, andadverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs
Assist in ensuring all data is entered into the sponsor's and/or vendor's data portal and all queries are resolved in a timely manner
Assist in ensuring staff are delegated and trained appropriately and training is accurately documented
Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope of the protocol and local law and regulations.
Promote respect for cultural diversity and conventions with all individuals.
Other duties as assigned
Qualifications
Education/Experience:
Associate's degree OR
High School Graduate and/or technical degree with minimum of 1 year relevant experience in the life science industry
Required Licenses/Certifications:
Phlebotomy if applicable and required by state law
Intramuscular dose administration and preparation if applicable and required by state law
Required Skills:
Demonstrated knowledge of medical terminology
Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
Basic ability to work in a fast-paced environment
Demonstrated verbal, written, and organizational skills
Demonstrated interpersonal and communication skills
Demonstrated ability to work as a team player
Demonstrated ability to read, write, and speak English
Basic ability to multi-task
Demonstrated ability to follow written guidelines
Basic ability to work independently, plan and prioritize with some guidance
Basic ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.
Required Physical Abilities:
Sit or stand for long periods of time
Travel locally
Communicate in person and by a telephone
Limited walking required
Limited to lifting up to 30 pounds
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Auto-ApplySenior Clinical Research Coordinator
Clinical research coordinator job in Irving, TX
Job Description
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.
2+ years' experience in clinical research, required.
2+ years' experience working as a Clinical Research Coordinator, 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!
Animal Research Study Coordinator, Radiation Oncology
Clinical research coordinator job in Dallas, TX
Animal Research Study Coordinator, Radiation Oncology - (907498) Description WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!
JOB SUMMARY
Works under general supervision of Manager in the Companion Animal Clinic in the Department of Radiation
Oncology to provide expertise in coordinating companion animal research trials. May conduct data management as needed. Collects and ensures quality control of animal research data in support of research studies. BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% coverage for preventive healthcare-no copay
Paid Time Off, available day one
Retirement Programs through the Teacher Retirement System of Texas (TRS)
Paid Parental Leave Benefit
Wellness programs
Tuition Reimbursement
Public Service Loan Forgiveness (PSLF) Qualified Employer
Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATION
RequiredEducationBachelor's Degree or higher degree in Animal Science, Clinical Research, Veterinary Science, or a related field Experience1 year clinical research experience PreferredExperience1 year prior experience in coordinating companion animal clinical trials is highly preferred Licenses and Certifications ACRP certification is a plus Upon Hire or
GCP certification is a plus Upon Hire or
SOCRA certification is a plus Upon Hire JOB DUTIES Oversees all aspects of companion animal research trials, from planning and recruitment to data collection and analysis.
Collaborates with veterinarians, animal owners, and research staff to identify suitable participants for animal trials.
Ensures adherence to ethical and regulatory guidelines, including IACUC, USDA and FDA requirements.
Coordinates the procurement of clinic supplies, reagents, and equipment for the various trials.
Manages trial resources, including budgets, supplies, and equipment, to ensure efficient trial execution.
Serves as a liaison between researchers, participants, and veterinary staff, providing clear and timely communication throughout the trial process.
Maintains thorough and organized trial documentation, including informed consent forms, protocols, and study reports.
Coordinates efficiently with the lab manager, technicians, and other staff of companion animal clinic.
Coordinates regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies.
Coordinates and schedules study procedures as per protocol. Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI.
When outside of protocol, presents evidence and provides options (within scope of protocol) to PI.
Screens, recruits, enrolls and follows subjects according to protocol guidelines. May also assist with the consent process.
Maintains and coordinates data collection information required for each study which may also include developing CRF's or data collection tools.
Assists in developing and implementing research studies to include writing clinical research protocols.
Conducts study procedures according to the protocol with proper training and check offs to maintain scope of work.
Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed.
May review and abstract information from medical records for verification of eligibility for trials.
Reviews research study protocols to ensure feasibility.
Performs other duties as assigned.
SECURITY AND EEO STATEMENTSecurityThis position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.EEO
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Primary Location: Texas-Dallas-5323 Harry Hines BlvdWork Locations: 5323 Harry Hines Blvd 5323 Harry Hines Blvd Dallas 75390Job: Research & LaboratoryOrganization: 427009 - RO-VROC Vet Rsrch Onclgy ClinSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Nov 18, 2025, 5:14:21 PM
Auto-ApplyPT Study Coordinator
Clinical research coordinator job in Austin, TX
Full-time Description
The Research Coordinator specializes in developing, planning, and implementing the SerenaGroup Research Program. The research coordinator will work directly with the CRO to develop specific workflows for the assigned clinical trials and implement an organized structure, including community education, referral sources, and educational programs. The Research Coordinator will work with the Principal Investigator (PI), CRO, and sponsor(s) to support and guide the administration of each clinical study's compliance, financial, personnel, and other related aspects.
Job Type: Full-time
Pay: From $25.00 per hour
Schedule:
8-hour shift
Monday to Friday
No nights
No weekends
Work Location: Hybrid remote in Austin, TX
Requirements
Language Ability:
Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization. Knowledge of modern equipment and ability to maintain confidentiality and exert physical effort to maintain and distribute files.
Math Ability:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Computer Skills:
Proficient in Microsoft Office, Outlook, Excel, PowerPoint, and Word; able to navigate through internet and intranet. Ability to learn internal clinical outcome database, upload photographs from camera.
Environment Expectations:
Work Environment:
The incumbent in this position is not required to work under any extreme condition and must be able to work around a moderate noise level, such as an office environment.
Physical Demands:
The incumbent in this position typically has to stand approximately 20% of the time, walk 20% of the time, and sit 60% of the time. In addition, this person talks or hears 100% of the time.
Accountability:
The Clinical Research Coordinator is accountable for the day-to-day operations of ensuring the clinical trial program runs smoothly, including phone messages, faxes to physicians and staff, database entry, billing entry, etc.
Specific Individual Considerations:
The designation of "essential functions" and "other duties" is for purposes of compliance with the Americans with Disabilities Act. This job description should not be construed to imply that these requirements are the only duties, responsibilities, and qualifications for this position. Incumbents may be required to follow any additional related instructions, acquire related job skills, and perform other related work as required. Incumbents in this position may be required to perform all or some of the above duties and responsibilities with varying concentration levels based on the incumbents' skill level and program needs.
Clinical Trial Screening Coordinator
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 clinical research 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 clinical research 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
Research Nurse Coordinator
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 clinical research 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 clinical research.
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.
Auto-ApplyClinical Research Coordinator San Antonio
Clinical research coordinator job in San Antonio, TX
The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.
Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned.
Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation.
Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46).
Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information.
Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable.
Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights.
Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety.
Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times.
Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed.
Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed.
Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner.
Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research.
Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections.
Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed.
Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution.
Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.
Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial.
Adheres to the USRC Research quality assurance program guidelines.
Travel to Investigator Meetings or similar research related meetings is required.
Travel may be required between dialysis facilities or nephrology practices within the community.
Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications.
May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.
Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization.
Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.
Participate in staff meetings as required.
Regular and reliable attendance is required for the job.
Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization.
Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures.
Regular and reliable attendance is required for the job.
Research Nurse Coordinator
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 clinical research 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 clinical research.
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.
Auto-ApplyClinical Research Coordinator I
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 clinical research 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.
Clinical Study Coordinator
Clinical research coordinator job in Fort Worth, TX
Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description
The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager.
In this job you will:
Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution.
Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time.
Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria.
Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff.
Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed.
Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment.
Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual.
Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution.
Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments.
Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions.
Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding.
Assist site staff with maintaining appropriate temperature monitoring for study products and supplies.
Support the contract and budget negotiations and oversees Investigator/Site Payments.
Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation.
Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc.
Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections.
Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs).
May be involved in the on-site training of additional staff as part of the SEO or other education programs.
Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements.
Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II.
SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope.
Qualifications
Education
Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects.
Certifications
Current Good Clinical Practice (GCP)
International Air Transport Association (IATA)
Current Basic Cardiopulmonary Resuscitation (CPR)
Phlebotomy certification unless part of active professional licensure (RN or LPN)
Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified.
Additional Information
Located in Fort Worth, Texas (On-site position).
If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!
Clinical Research Coordinator
Clinical research coordinator job in Fort Worth, TX
Who We Are JPS Health Network is a $950 million, tax-supported healthcare system in North Texas. Licensed for 582 beds, the network features over 25 locations across Tarrant County, with John Peter Smith Hospital a Level I Trauma Center, Tarrant County's only psychiatric emergency center, and the largest hospital-based family medical residency program in the nation. The health network employs more than 7,200 people.
Acclaim Multispecialty Group is the medical practice group featuring over 300 providers serving JPS Health Network. Specialties range from primary care to general surgery and trauma. The Acclaim Multispecialty Group formed around a common set of incentives and expectations supporting the operational, financial, and clinical performance
outcomes of the network. Our goal is to provide high quality, compassionate clinical care for every patient, every time.
Why JPS?
We're more than a hospital. We're 7,200 of the most dedicated people you could ever meet. Our goal is to make sure the people of our community get the care they need and deserve. As community stewards, we abide by three Rules of the Road:
1. Own it. Everyone who wears the JPS badge contributes to our journey to excellence.
2. Seek joy. Every day, every shift, we celebrate our patients, smile, and emphasize positivity.
3. Don't be a jerk. Everyone is treated with courtesy and respect. Smiling, laughter, compassion - key components of our everyday experience at JPS.
When working here, you're surrounded by passion, diversity, and dedication. We look forward to meeting you!
For more information, visit *********************
To view all job vacancies, visit ********************* ***************************** or ********************
Job Title:
Clinical Research Coordinator
Requisition Number:
42785
Employment Type:
Full Time
Division:
EDUCATION & LIBRARY
Compensation Type:
Salaried
Job Category:
Nursing / LVN
Hours Worked:
8am-5pm
Location:
John Peter Smith Hospital
Shift Worked:
Day
Job Description:
Description: The Clinical Research Coordinator is responsible for assisting investigators with the conduct of new or ongoing intervention studies supported by the JPS Health Network Research Institute. This position is involved in intervention studies pertaining to injuries, chronic diseases, and infectious diseases.
Typical Duties:
* Assists with the development of research protocols, recruitment strategies, budgets, and data collection forms in collaboration with research team.
* Prepares regulatory reports and Institutional Review Board submissions and ensures compliance and preparedness for internal and external audits and study monitoring visits.
* Coordinates and manages intervention studies, including but not limited to participant recruitment and enrollment, data collection, development and use of case report forms, adverse events reporting, filing and archiving of study records, resolution of data queries, and communication with sponsors and regulatory authorities.
* Ensures participant safety and confidentiality throughout all phases of research.
* Trains staff and volunteers on the implementation of research protocols.
* Maintains databases and ensures timely and accurate documentation of study-related information.
* Assists with writing internal reports, as necessary.
* Rotates on a weekly on-call schedule to meet study needs.
* Attends investigator meetings that may require out-of-state travel, as needed.
* Performs other related duties as assigned.
Qualifications:
Required Education and Experience:
* Bachelor's degree in a health-related field from an accredited college or university.
* 2 plus years of clinical research experience or 4 plus years of clinical nursing experience.
Required Licensure/Certification/Specialized Training:
* Completion of human subjects protection training within 30 days of hire.
* If applicable, individuals with a professional license (e.g. nurses) must maintain current licensure.
Preferred Education and Experience:
* Master's degree in a health-related field from an accredited college or university.
* 2 plus years of experience in regulatory compliance and conduct of clinical trials.
Preferred Licensure/Certification/Specialized Training:
* Certified Clinical Research Professional through the Association of Clinical Research Professionals or the Society of Clinical Research Associates.
Location Address:
1500 S. Main Street
Fort Worth, Texas, 76104
United States
Clinical Research Associate - Oncology - West Region (AZ, CO, CA, UT)
Clinical research coordinator job in Colorado City, TX
ICON plc is a world-leading healthcare intelligence and clinical research 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 clinical research 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 (AZ, CO, CA, UT) 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