Job Closed
This listing is no longer active.
Clinical Research Associate
Location
Czechia
Posted
73 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Research Associate
ICON plc
Clinical Research Associate 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 As a CRA I at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programmes. What You Will Do: Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation - Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required. - Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. - Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements. Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - University degree in medicine, science, or equivalent - Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data - Excellent written and verbal communication in English - Good social skills enabling you to deal with queries in a timely manner - Willingness to travel as required (approximately 60%) 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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
Related Guides
Related Categories
Related Job Pages
More Clinical Research Jobs
Clinical Education Specialist
EssityA global, leading hygiene and health company #BreakingBarriersToWellbeing
Edukačná sestra (Clinical Education Specialist) Náš tím sa rozrastá, preto k nám hľadáme nového kolegu/kolegyňu na pozíciu Edukačná sestra (Clinical Education Specialist). Aká bude tvoja pracovná náplň Medzi Tvoje hlavné úlohy a zodpovednosti bude patriť: • profesionálna podpora nových zákazníkov pre portfólio inkontinenčných pomôcok a kozmetiky TENA • aktívne vyhľadávanie nových zákazníkov pre portfólio prostriedkov na hojenie rán • starostlivosť o existujúcich zákazníkov v oblasti portfólia prostriedkov na hojenie rán a portfólia hygienických pomôcok pre inkontinentných pacientov • jednodňové/dvojdňové návštevy zdravotníckych zariadení (nemocnice, LDN, polikliniky, súkromné ambulancie a kliniky, zariadenia sociálnej starostlivosti pre seniorov) za účelom preškolenia zdravotníckeho personálu v správnej praxi pri starostlivosti o hojenie rán (dekubity, vredy predkolenia, diabetickej ulcerácie, popáleniny, jazvy atď. • jednodňové/dvojdňové návštevy zdravotníckych zariadení (zariadenia sociálnej starostlivosti pre seniorov, nemocnice, LDN), za účelom preškolenia zdravotníckeho personálu v správnej praxi pri starostlivosti o inkontinentného pacienta, s praktickým nácvikom pri lôžku • pravidelné interné preškoľovanie nových a existujúcich zamestnancov • účasť na kongresoch a konferenciách (aktívna prezentácia firmy) • vzdelávanie pracovníkov v sociálnych službách - akreditované kurzy MPSV, semináre, produktové workshopy Kto si Ak spĺňaš nasledujúce, si ideálny kandidát/ka • SŠ, VOŠ, VŠ zdravotníckeho zamerania (všeobecná sestra) • prax v odbore (ideálne v rámci chirurgických odborov, hojenie rán) • prezentačné a organizačné schopnosti • schopnosť budovania obchodných vzťahov • samostatnosť • adaptabilita, empatia a spoľahlivosť • znalosť práce na PC (Word, Excel, Powerpoint, Outlook) • miesto výkonu práce - územia celého Slovenska podľa vopred určeného contact listu • aktívny vodič (skupina B) • výhodou znalosť angličtiny na úrovni B1/2 Čo Ti môžeme ponúknuť V Essity veríme, že každá kariéra je jedinečná tak, ako je jedinečný každý zamestnanec. Preto zamestnancov podporujeme v rozvíjaní ich potenciálu za pomoci našej víťaznej kultúry motivovanej naším poslaním. Základný plat na tejto pozícii je minimálne 2050 € btto mesačne + ďalšie benefity (13. plat, 14. plat, Bonus za dochádzku a ďalšie zaujímavé benefity, o ktorých Ti radi povieme viac počas pohovoru) Innovate for Good | Excel Together | Be You with Us #LI-KC1 Application End Date: 28 apr 2026 Job Requisition ID: Essity257736
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. REGISTER YOUR INTEREST FOR UPCOMING OPPORTUNITIES Parexel are registering interest for sponsor dedicated Senior Clinical Research Associate roles, to be based in the UK. Experience in oncology trials and RECIST criteria is essential. A minimum of 3 years' experience in CRO or Pharma trials environments is also essential. The Senior CRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. The Senior CRA will collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready and will coordinate with institutions and investigators at the local level. Some specifics about this advertised role Oversight of Monitoring Responsibilities and Study Conduct - Ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required. - Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues. - Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations. - Conducts source document review and verification of appropriate site source documents and medical records. Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete. - Manages reporting of protocol deviations and appropriate follow up. - Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. - May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security. - Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP. - Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned. - Manages reporting of identified issues and manages follow up to resolution. - Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP. - Ensures all activities are managed by site personnel who are appropriately delegated and trained. - Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met. (Must be able to quickly adapt to changing priorities to achieve goals and targets). - Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. - Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date. Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.) - Conducts follow up for escalated adverse event monitoring (AEM) report queries. - Checks the site and external facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable). - Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log). Collaboration - Collaborates with primary Site Manager who will act as the primary liaison with site personnel. - Prepares for and attends Investigator Meetings and sponsor face to face meetings. - Participates in global clinical monitoring and project staff meetings (inclusive of client representation, as applicable) and attends clinic. Who are Parexel? Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team. What we are looking for in this role For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart. Here are a few requirements specific to this advertised role. Skills - Networking and relationship building skills. Ability to communicate effectively and appropriately with internal and external stakeholders. - Ability to adapt to changing technologies and processes. Effectively overcoming barriers encountered during the implementation of new processes and systems. - Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization. - Identifies and builds effective relationships with investigator site staff and other stakeholders. - Proficiency in local language is required. - Fluency in English is required. Education Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience. Not quite the role for you? Join Our Talent Community and we’ll reach out with job alerts when positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events. Sign up today https://jobs.parexel.com/functional-service-provider
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Site Management Responsibilities - Contributes to the selection of potential investigators. - In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. - Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. - Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. - Actively participates in Local Study Team (LST) meetings. - Contributes to National Investigators meetings, as applicable. - Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. - Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. - Updates CTMS and other systems with data from study sites as per required timelines. - Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. - Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. - Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. - Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. - Ensures data query resolution in a timely manner. - Works with data management to ensure robust quality of the collected study data. - Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. - Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. - Follows up on outstanding actions with study sites to ensure resolution in a timely manner. - Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. - Assists site in maintaining inspection ready ISF. - Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). - Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. - Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. - Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. - Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager Compliance with Sponsor Standards - Ensures compliance with the Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). - Ensures compliance with local, national, and regional legislation, as applicable. - Completes timesheets accurately as required Skills (Essential): - Excellent attention to detail. - Good written and verbal communication skills. - Good collaboration and interpersonal skills. - Good negotiation skills. - Proficient in written and spoken English language required. - Fluency in local language(s) required. Skills (Desirable): - Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. - Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. - Good analytical and problem-solving skills. - Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. - Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. - Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): - Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. • Good knowledge of relevant local regulations. - Good medical knowledge and ability to learn relevant Client Therapeutic Areas. - Basic understanding of the drug development process. - Good understanding of Clinical Study Management including monitoring, study drug handling and data management. Knowledge and Experience (Desirable): - Familiar with risk-based monitoring approach including remote monitoring. - Good cultural awareness. Education: - Bachelor’s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. Other: - Ability to travel nationally/internationally as required. - Valid driving license per country requirements, as applicable
Title: Associate Professor, Clinical Faculty Appointment (CFA) - Musculoskeletal Imaging - Requisition #:180133 - Department:Musculoskeletal Imaging Dept - Location:Houston, TX Job Description: The University of Texas MD Anderson Cancer Center is a world-renowned center for oncological care and research. The Department of Musculoskeletal Imaging, Division of Diagnostic Imaging at MD Anderson Cancer Center invites applications for a full-time, open rank clinical faculty appointment. The department prides itself on its balanced work-life and collegial culture. The Musculoskeletal Imaging Department consists of 11 musculoskeletal radiologists who provide diagnostic imaging services to diagnose, stage, and follow-up patients with known or suspected malignancy using conventional radiographs, computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET). Members of the department are responsible for the following: - Delivering excellent, comprehensive, and compassionate care for patients; - Providing multimodality approaches to musculoskeletal imaging including CT, MRI, whole body MRI, PET, and conventional radiography; - Educating medical students, residents, and fellows; - Developing academic and scholarly programs and projects; and - Fostering interdisciplinary and collaborative approaches to clinical care, research, and education. This position consists of a target base salary, various incentive/bonus compensation, and retirement benefits placing our remuneration package well in the 75th percentile nationally. Comprehensive health, wellness, time off, and various savings benefits are also included. The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition. This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html Additional Information - Requisition ID: 180133 - Employee Status: Regular - Minimum Salary: US Dollar (USD) 0 - Midpoint Salary: US Dollar (USD) 0 - Maximum Salary : US Dollar (USD) 0 - FLSA: exempt and not eligible for overtime pay - Work Location: Hybrid Onsite/Remote #LI-Hybrid

