CRA II or Senior CRA
Location
Oman + 1 moreAll locations: Oman | Romania
Posted
37 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
CRA II or Senior CRA
ICON plc
CRA II or Senior CRA - Romania - Remote 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 II or Senior CRA at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: - Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. - Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. - Collaborating with investigators and site staff to facilitate smooth study conduct. - Performing data review and resolution of queries to maintain high-quality clinical data. - Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - Bachelor's degree in a scientific or healthcare-related field. - Minimum of 2 years of experience as a Clinical Research Associate. - Oncology experience is required - In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. - Strong organizational and communication skills, with attention to detail. - Ability to work independently and collaboratively in a fast-paced environment. - Willingness to travel as required (approximately 60%) #LI-DK2 #LI-Remote 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
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Regulatory and Start Up Specialist
Precision Medicine GroupPrecision Medicine Group delivers specialty services that help its life science clients navigate healthcare challenges. The company entered its 10th year of suc
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site. • Review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF. • May support the clinical team performing Pre-Study Site Visits.
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits.
International consultant on adoption of cervical cancer treatment clinical protocols and development of compliance monitoring indicators
UNFPAUNFPA is the lead UN agency for delivering a world where every pregnancy is wanted, every childbirth is safe and every young person's potential is fulfilled. UNFPA’s strategic plan (2022-2025) reaffirms the relevance of the current strategic direction of UNFPA and focuses on three transformative results: To end preventable maternal deaths. End unmet need for family planning. End gender-based violence and harmful practices. UNFPA provides a work environment that reflects the values of gender equality, diversity, integrity and healthy work-life balance.
TERMS OF REFERENCE Hiring office: UNFPA Turkmenistan CO Title: Individual consultancy services (international) on adoption of cervical cancer treatment clinical protocols and development of compliance monitoring indicators. The background and purpose of consultancy: Cervical cancer remains the 2nd top leading cause in cancer mortality after breast cancer among women in Turkmenistan, but also curable if detected early and adequately treated. The annual number of new cervical cancer cases in the world has been projected to increase from 570 000 to 700 000 between 2018 and 2030, with the annual number of deaths projected to increase from 311 000 to 400 000. UNFPA supports the national government in strengthening the healthcare system, emphasizing accessible, high-quality cervical cancer screening and treatment. Efforts in Turkmenistan to eliminate cervical cancer include supporting HPV vaccination for both girls and boys, promoting screening initiatives, and guaranteeing access to treatment for diagnosed individuals. By implementing organized screening and treatment programs, UNFPA aims to decrease cervical cancer burden of disease. UNFPA has supported training of up to 80% of the country's cytologists and colposcopists. The capacity of the national colposcopists is strengthened with regard to improving early detection and treatment of cervical cancer. UNFPA also prioritizes on ensuring timely, high-quality treatment by supporting the development of chemotherapy and other essential cancer treatment facilities. UNFPA provided support to national oncologists in 2025 to update and improve chemotherapy protocols for treating cervical and breast cancer. There is a recognized need to further enhance the capacity of oncologists, in the treatment of cervical cancers. Treatment protocols and methods need to be updated to align with WHO recommendations, current evidence, and the latest medical advancements. Through these integrated efforts, UNFPA aims to improve 5-year survival rates for women with cervical cancers, thereby increasing life expectancy and overall well-being. This comprehensive approach reflects UNFPA's dedication to women's health and reducing the impact of these cancers on SRH-related morbidity rate. Therefore, there is a need for an international specialist to assess existing protocols, support updating of the clinical protocols, and deliver training to national oncologists in Turkmenistan. There is a recognized need to update clinical protocols to align with WHO recommendations and latest medical advancements. Furthermore, to ensure these updates translate into patient care, there is a critical need for a clinical compliance framework. This consultancy aims to develop updated clinical protocols and a manual peer-review methodology with specific indicators to monitor adherence at both the national and hospital levels, ensuring a unified standard of care. Scope of work: The international expert will work with UNFPA RH NPO and national MOHMI specialists on adoption of treatment protocols including the following stages: - Assessment and revision phase - 10 working day - Desk review of existing treatment protocol for cervical cancers. - Conduct 1 (one) online technical meeting to clarify with national oncologists on the cervical cancer treatment opportunities and current methodologies. - Support update of cervical cancer protocol to align with WHO standards and international good practices. - Conduct 3 days online training with national specialists on the updated clinical protocol. - Methodology development - 10 working days - Develop a Manual Peer-Review Methodology for clinicians to assess adherence to protocols as a part of the quality assurance cycle. - Define Clinical Compliance Indicators for national monitoring and internal audit - Conduct a one day online workshop with national specialists to refine and finalize the methodology. - Reporting phase - 2 working days - Develop a final consultancy report. Duration and working schedule: The Duration of this consultancy is 22 working days, from May 18th to September 30th 2026 including operational closure of the contract. Dates may vary due to availability of the expert and the national partners. Outcomes and deliverables: The timeline below shows the final dates of delivery and can be performed earlier than that Deliverable 1. Assessment Report, including a desk review of current protocols, a summary of technical recommendations from online meetings, and the first draft of updated clinical protocols for cervical and breast cancer aligned with WHO standards developed by June 30th Deliverable 2. 3-day online training conducted for national specialists on the updated clinical protocols by July 25th. Deliverable 3. One day online workshop for national partners on Manual peer-review methodology and clinical compliance indicators conducted by August 10th. Deliverable 4. A complete package consisting of the manual peer-review methodology, the set of clinical compliance indicators developed by August 20th. Deliverable 5. Final consultancy report developed by September 25th. Place where services are to be delivered: The consultancy services will need to be delivered online. Delivery dates and how work will be delivered: Dates for deliverables as indicated in the outcomes and deliverables section. All deliverables should be submitted in an electronic format. Monitoring and progress control, including reporting requirements, periodicity format and deadline: The UNFPA Programme Analyst on Reproductive Health will monitor the International Consultant’s work through reviewing submitted materials. The consultant will provide an update on a weekly basis on progress, challenges encountered, and support requirements. Ethical Considerations UNFPA requires its consultants to adhere to ethical principles and standards when doing research. The selected consultant should clearly identify any potential ethical issues and approaches, as well as the processes for ethical review in the inception report. National Ownership The involvement of appropriate national partners will be a critical condition for the development of all the mission outcome materials in ensuring stakeholder ownership and its subsequent utilisation. Supervisory arrangements: The International Consultants will directly work under the supervision of and report to the UNFPA Programme Analyst on reproductive health, along with the overall guidance from the UNFPA Head of Office. Expected travel: Travel is not expected under this consultancy. Required expertise, qualifications, and competencies including language - Advanced degree in medical sciences (Oncology and Gynaecology); - Qualified oncologist possessing minimum 7 years of relevant experience. - Knowledge of existing WHO recommendations and good practices as well as evidence collected by research institutions and societies. requirements: - Experience in development of protocols, clinical guidances or recommendations , methodologies and. - Fluency in Russian or English; - Familiarity and experience with the Central Asian context is an asset. Inputs / services to be provided by UNFPA or implementing partner, if applicable: UNFPA will provide the consultant with all the necessary materials, data, information, and available reports. The UNFPA Country Office will put together a list of core sources and readings before the start of the consultancy. Other relevant information or special conditions, if any: The consultancy fee will be calculated based on the P-4 level of the of the UN Salary Scale for Professional and higher categories effective 1 January 2026 and will be paid in a lump sum upon successful completion of deliverables. UNFPA provides a work environment that reflects the values of gender equality, diversity, integrity and healthy work-life balance. We are committed to ensuring gender parity in the organization and therefore encourage women to apply. Reasonable accommodation may be provided to applicants with disabilities upon request, to support their participation in the recruitment process. Persons with disabilities, and individuals of other underrepresented groups are highly encouraged to apply. UNFPA promotes equal opportunities in terms of appointment, training, compensation and selection for all regardless of personal characteristics and dimensions of diversity.
Position Title: Behavioral Health Compliance Manager Locations: GA-ATLANTA, 740 W PEACHTREE ST NW OH-MASON, 4241 IRWIN SIMPSON RD VA-RICHMOND, 2015 STAPLES MILL RD, TN-NASHVILLE, 22 CENTURY BLVD, STE 310 TX-GRAND PRAIRIE, 2505 N HWY 360, STE 300 FL-MIAMI, 11430 NW 20TH ST, STE 300 time type Full time job requisition id JR187751 Job Description: Behavioral Health Compliance Manager Location: This role requires associates to be in-office 1 - 2 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Alternate locations may be considered if candidates reside within a commuting distance from an office. Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law. The Behavioral Health Compliance Manager is responsible for supporting all lines of business by providing advanced regulatory, clinical, and operational compliance expertise. This role serves as a key subject matter expert (SME) in behavioral health, combining compliance knowledge with clinical insight to interpret complex regulatory requirements, assess business impact, and guide implementation. This role requires strong collaboration across internal teams and external partners, including health plan compliance organizations, to ensure aligned, practical, and compliant solutions. How You Will Make an Impact: - Support regulatory audits/exams, internal audits. - Conduct mock audits, audit training, and oversee audit evidence preparation. - Assess audit readiness, identify gaps, and guide development of remediation strategies. - Perform risk assessments and support mitigation planning across behavioral health operations. - Establish project plans, gap analysis, milestone dates, and other significant aspects, and leadership updates. - Provide compliance input into new and evolving program initiatives, including new concepts, regulatory questions, and business models. - Evaluate compliance implications and risks, ensuring alignment with regulatory expectations. - Serve as a behavioral health compliance SME, providing clear, actionable guidance on regulatory requirements across lines of business. - Conduct complex research and in-depth analysis of federal and state regulations, translating findings into practical compliance recommendations. - Apply knowledge of behavioral health practices (e.g., levels of care, utilization management, treatment models) to inform regulatory interpretation and risk identification. - Partner with internal stakeholders and health plan compliance teams to align on regulatory interpretation and implementation. - Lead complex compliance investigations, including those involving behavioral health considerations. - Document findings, perform root cause analysis, and ensure appropriate corrective actions are implemented. Minimum Requirements: - Requires a BA/BS and minimum of 6 years health care, regulatory, ethics, compliance or privacy experience; or any combination of education and experience, which would provide an equivalent background. - Ability to travel may be required. Preferred Skills, Capabilities, & Experiences: - Strong knowledge of behavioral health operations and clinical concepts (e.g., levels of care, utilization management). - Demonstrated experience interpreting and applying healthcare regulations. - Ability to conduct complex regulatory research and translate into actionable compliance guidance. - Clinical background or licensure (e.g., LCSW, LPC, LMFT, RN, or similar) strongly preferred. - Advanced degree (MS, MBA, JD) or relevant certification (e.g., CHC, CHPC). - Experience working with health plans and behavioral health organizations, including Medicare/Medicaid. Job Level: Non-Management Exempt Workshift: 1st Shift (United States of America) Job Family: FRD > Compliance Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act. Prospective employees required to be screened under Florida law should review the education and awareness resources at HB531 | Florida Agency for Health Care Administration. NOTE: Workday keeps job postings active through 11:59:59 PM on the day before the listed end date. Example: If the end date is 3/13, the posting will automatically come down on 3/12 at 11:59:59 PM. In other words - the job is posted until 3/13, not through 3/13.


