Clinical research coordinator jobs in Odessa, TX

ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we've supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you'll join a collaborative community committed to making a meaningful impact on global health. We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. ABOUT THE JOB The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.HERE IS WHAT YOU WILL DO: Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit including qualification, initiation, interim, and close out site visits Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion Manage, prepare, send, track, and return investigational supplies at individual sites Monitor and document investigational product dispensing, inventory, and reconciliation Monitor and document laboratory sample storage and shipment Monitor trial by reviewing and reporting on site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues Review data queries and listings, and work with the study centers to resolve data discrepancies Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues Maintain complete and accurate study files and review files to ensure all appropriate documentation is present Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials Follow Good Documentation Practices, complete Visit Reports and site correspondence in accordance with SOPs HERE IS WHAT YOU BRING TO THE TABLE: Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training 2 years of prior experience as a Clinical Research Associate preferred Detail oriented Excellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skills Flexibility with changing priorities Ability to efficiently perform and prioritize multiple tasks Familiarity with medical and pharmaceutical industry, and related terminology and practices Extensive knowledge of FDA regulations and their practical implementation Ability to travel, including by air or by car on short notice A valid driver's license with access to a car with up-to-date car insurance Proficiency in Microsoft Word, Excel, and PowerPoint HERE IS WHAT WE OFFER: Your wellness matters to us - that's why we provide full medical, dental, and vision insurance options for you and your family. We know life doesn't pause for work - we provide flexible PTO so you can take care of what matters, both personally and professionally. You invest in your future - and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. At ProTrials, we are committed to your growth. Whether you're looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward. We have the best coworkers, if we do say so ourselves. Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant's personal information in accordance with its statutory obligations and internal policies and procedures. Information collected during application completion may be retained for a reasonable period of time and in accordance with the company's established retention policies. Applicants seeking more information may contact ****************. ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.

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

Regulatory Associate, Office of Clinical Research - (909774) 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 limited supervision to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies ethical principles and multiple regulations to complex scientific research projects. 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 equivalent Experience2 years of related experience May consider experience and education in lieu of requirements. JOB DUTIES Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements. Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy. Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use. Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities. Perform 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: Professional & ExecutiveOrganization: 222005 - OCR-Core Clinical Rsch UnitSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Dec 9, 2025, 3:13:46 AM

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary Job Description ROLE The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. KEY RESPONSABILITIES * Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits. * Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. * Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. * Ensures integrity of CRF data through meticulous and thorough source document review and verification. * Conducts investigational product accountability. * Reviews regulatory binder for required documents. * Works closely with in-house CRAs and data management to resolve queries on discrepant data. * Proactively identifies site issues and develops problem-solving strategies for sites. * Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. * Conducts audit preparation at study sites as needed. * Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. * Manages and resolves conflicting priorities to deliver on commitments. * Complies with ICH GCP guidelines, FDA regulations, and company SOPs. * Participates in industry and client meetings. * Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE * BS/BA from an undergraduate program or equivalent experience * 2 years of clinical research experience TECHNICAL COMPETENCES & SOFT SKILLS * Ability to travel. * Proven ability to be careful, thorough, and detail-oriented. * Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment. * Self-starter who thrives in a collaborative, yet less structured team environment * Ability to problem-solve unstructured or ambiguous challenges. * Strong command of English, both written and verbal. * Excellent communication and interpersonal skills with customer service orientation. * Proficient with MS Office Suite, particularly Word and Excel. * Permanent authorization to work in the country where you are applying. Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular

Coordinator Clinical Research Senior, Center for OCR - Galveston - (2507038) Description Minimum Qualifications: Bachelor's degree and five years experience as clinical research coordinator or equivalent experience. PreferredPrevious clinical research experience Job Summary: The Senior Clinical Research Coordinator manages clinical research projects for Principal Investigators by gathering patient data via methods specified in the study protocol. Provides complex administrative duties in support of the study to insure compliance with regulations. Job Duties:Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities. Under the direction of the PI, supervises and assists with the preparation and submission of all IRB and Regulatory Documents to obtain final approval and may draft various communications with Sponsor. Attends and participates in the Investigator meeting. Reviews goals and requirements of any new protocols and coordinates study initiation. Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals. Assesses staffing needs based upon current research activity and implements changes in staffing as needed Participates in protocol initiation visits Plans and designs source documentation for protocol Develops assessment tool per protocol to use in clinical research and teaches research team and hospital personnel how to use the assessment tool as allowed per medical practice. Develops procedures for laboratory collection and storage. Assists in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations. Maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy. Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor. Precepts new clinical research staff and educates research staff regarding scientific aspects of studies. Provides performance management for staff under direction of PI. Assesses communication process within Department and/or services required by the protocol. Elicits relevant data from sources outside of the hospital. Assists PI in budget development; may monitor ledgers. Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures return of test article /clinical supplies; maintains regulatory standards. Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment. Monitors participants labs and notifies the PI of laboratory findings. Serves as a role model and resource for the clinical research staff. May assist PI in obtaining Informed Consent from study participant and documents appropriately. Adheres to internal controls established for department. Salary Range:Actual salary commensurate with experience or range if discussed and approved by hiring authority. 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: 0342 - Research Building 6 301 University Blvd. Research Building 6, rm 6. 174 Galveston 77555-0342Job: Clerical & Administrative SupportOrganization: UTMB Health: RegularShift: StandardEmployee Status: SupervisorJob Level: Day ShiftJob Posting: Dec 16, 2025, 6:50:58 PM

Accurately identifies part requirements from cross functional departments (Operations, AMS, and Shop) and creates requisitions for parts, service or expenses. Skills and Abilities: Ability to: - Ask the right questions about what is needed and help the requestor through the process of identifying the correct part, service or expense. - Communicate verbally and in writing with cross- functional departments (Operations, AMS, and Shops) and with Suppliers. Knowledge: - Fully understands the requisition process. - Detailed understanding of gas compression equipment - components, parts, and supply base. - Exhibits deep knowledge of how Oracle works, how to look up part numbers, and when to use a P- Card. Minimum Education and Certification: - High School diploma or GED equivalent. Minimum Experience: - Typically at least five years of experience in procurement and/or with gas compression or similar equipment and parts. Leadership: - Expected to serve as a resource to others for knowledge transfer, training and checking work. - May occasionally lead a team. Physical Demands: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions) - Regularly required to stand, walk, and bend with good balance, use hands to finger, handle or feel and reach with hands and arms. - Regularly required to sit, perform repetitive duties, use a PC and to talk and hear. - Vision abilities include close vision, distance vision, color vision, and the ability to adjust focus. - Regularly required to lift, move and carry up to 10 pounds. Problem Solving & Innovation: - Recommends solutions to non-recurring problems by reviewing, interpreting and evaluating various precedents and data. - Anticipates and proactively solves moderately complex problems. - Expected to recommend and implement methods and procedures to improve efficiency within scope of role. Impact: - Actions and decisions impact operational and to some degree financial results This job description is a summary of essential job functions. It is not intended as an employment contract, nor is it intended to describe all duties someone in this position may perform. All employees are expected to perform tasks, as assigned by supervisor, regardless of job title or routine job duties. Essential Duties: - Demonstrate what system fields are required, how Oracle works, how to look up part numbers, and when to use a P-Card. - Efficiently and independently conduct extensive item and quantity on hand search within Enterprise (Local Subs, Business Unit, Region, and ODC) before submitting requisition to purchase. - Create/Track approved internal/purchase requisition for parts, service or expenses. - Respond to after-hours requests regularly on an on call basis. - Train/mentor less experienced Requisition Coordinators. Non-Essential Duties: Performs other duties as assigned. All employees shall be in compliance with the Archrock Health Safety and Environmental Policy and local, statutory and/or regulatory requirements at all times.

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.

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:

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. 4+ years' experience in clinical research, required. 4+ 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!

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

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.

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. 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 clinical research 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 clinical research 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.

We envision a future powered by robots that work seamlessly with human teams. We build the artificial intelligence that enables service robots to collaborate with people and adapt to dynamic human environments. Join our mission-driven, venture-backed team as we build out our customer-facing operations arm. As part of Diligent Robotics' founding operations team, you will uphold the highest standards for safe clinical use of robots in real-world hospital environments. Through excellent communication and documentation, you will work alongside the hospital staff and our engineering team while assisting a cutting-edge fleet of robots. As part of the founding team, you will help design and implement processes as the organization scales. Clinical Robot Associates will solve unexpected situations that might arise during a shift, and work effectively as a team to ensure exceptional results to our hospital partners. This is a full-time, Supervisor role at Diligent Robotics and working 9am-5pm CT, Monday-Friday. This position is located in Odessa, TX and you must be local to be considered. This is not an engineering position and a background in robotics or engineering is not required. If you have ever been an outstanding customer service representative helping busy customers with their needs, you may be a great fit for the role. Your day-to-day responsibilities will include: Monitoring and safely assisting mobile service robots in a hospital environment Collecting data and troubleshooting in a variety of real-world situations, while simultaneously providing detailed and accurate feedback to our engineers Prioritizing the customer experience, ensuring their expectations are always met or exceeded Communicating with hospital staff and, occasionally, the public regarding robot operation Your supervisory responsibilities will include: Prepare and publish monthly schedules Onboarding and training new Clinical Robot Associates Approve time cards Escalating corrective action issues Find coverage with callouts A good candidate would be, at minimum: A high school graduate or possess a GED Supervisory experience: Experience leading a small team including scheduling, training, and support. Customer-service oriented: you are friendly, skilled in the art of de-escalation, and an able juggler of customer demands and company needs An excellent written and verbal communicator: you convey information to internal stakeholders in phone calls and direct messenger Organized: you can juggle and make progress on multiple tasks simultaneously Self-sufficient: you get things done, learn what you don't know, and can make quick decisions independently, as circumstances require Able to lift up to 40 pounds Able to work varying shift times including nights and weekends and understanding that your schedule may shift as customer needs change over time Willing to work during significant holidays: you understand that our customers (i.e. hospitals) don't shut down during the holidays and neither can our robots Willing to be vendor credentialed: our customers have strict standards and employment will be dependent on obtaining vendor credentials, the process of which will include various immunizations, a background check, a drug screen, among other steps The ideal candidate would be: Extraverted: you can strike up a conversation with anyone and everyone loves your presence Responsive and responsible: you commit to deadlines, err on the side of over-communication, and understand the challenges of working with some co-workers that may be remote. Results-oriented: you're happy to observe and take notes on end users interacting with the robot all day if that's what it takes Passionate about healthcare and technology coming together to help people Formerly employed in the healthcare space: you have an insider understanding of the vernacular, organizational structure, and operational processes of hospitals Passionate and clear-eyed when it comes to robots: you understand that there's a gap between technological reality and media-driven expectations and are excited about the opportunity to move the industry forward by whatever means necessary, even if it isn't glamorous We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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

/RESPONSIBILITIES Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application. 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. xevrcyc Exercises mature judgment and discretion in any confidential or sensitive matters.

Thank you for considering a future career with ProTrials. While we are not currently hiring for this position at this time, we like to connect with skilled individuals interested in future opportunities. By submitting your application, you will be added to our talent pipeline and considered if a good match becomes available. ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we've supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries. Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you'll join a collaborative community committed to making a meaningful impact on global health. We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence. ABOUT THE JOBThe Lead Clinical Research Associate (LCRA) is responsible for providing direction and leadership to the Clinical Research Associate (CRA) team and Clinical Trial Associate (CTA) assigned to studies. The LCRA ensures accurate and timely initiation, enrollment, conduct, completion, and provides project management support. The LCRA ensures adequate study monitoring resources are in place for the study. The LCRA also identifies quality issues related to clinical monitoring activities, and along with the study team, establishes action plans to address them. HERE IS WHAT YOU WILL DO: Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies Create annotated visit report templates and other documents and strategies related to site management and monitoring Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed HERE IS WHAT YOU BRING TO THE TABLE: RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training Previous CRA experience preferred Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy Solutions-oriented approach to problem solving Familiarity with medical and pharmaceutical industry, and related terminology and practices Extensive knowledge of Food and Drug Administration regulations and their practical implementation Willingness to travel and perform remote and on-site monitoring, if needed Proficiency in Microsoft Word, Excel, and PowerPoint HERE IS WHAT WE OFFER: Your wellness matters to us - that's why we provide full medical, dental, and vision insurance options for you and your family. We know life doesn't pause for work - we provide flexible PTO so you can take care of what matters, both personally and professionally. You invest in your future - and so do we. Our 401(k) plan includes a company match to help you reach your financial goals. At ProTrials, we are committed to your growth. Whether you're looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward. We have the best coworkers, if we do say so ourselves. Except as otherwise permitted or required by applicable law or regulatory requirements, ProTrials will retain the applicant's personal information in accordance with its statutory obligations and internal policies and procedures. Information collected during application completion may be retained for a reasonable period of time and in accordance with the company's established retention policies. Applicants seeking more information may contact ****************. ProTrials is an equal opportunity employer. ProTrials is committed to providing a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration for employment without regard to race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.

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!

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

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator. 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 clinical research 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 clinical research 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.