Clinical research associate jobs in Urban Honolulu, HI - 17 jobs

**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_

Title: Research Associate Senior (Red Hill Registry Director of Science, 0077950T) 0077950T Hiring Unit: Thompson School of Social Work & Public Health, Dept of Public Health Sciences Closing Date: February 9, 2026 Salary: Salary schedules and placement information: ****************************************** Additional Salary Information: PBB, Commensurate with qualifications and experience Full Time/Part Time: Full Time Temporary/Permanent: Temporary Funding: Federal Funds Other Conditions: To begin approximately March 2026 or as soon thereafter. Position renewable upon availability of funds, program needs, and satisfactory performance Duties and Responsibilities * *Lead thestrategic scientific direction,execution, administrative coordination, and strategic compliance of the Red Hill Registry Science Team, ensuring all data collectioninstruments and utilization efforts align with registry's goals and deliverables. * *Collaborate with project stakeholders to further the registry's efforts to achieve project milestones. * *Represent the Red Hill Registry at selectedexternal meetings, conferences, and stakeholder engagements in coordination with the Director, maintaining professional relationships with key partners. * *Coordinate the identification and implementation of new initiatives and data-driven projects to enhance the Registry's long-term impact and sustainability. * *Identify relevant extramural funding opportunities and provide technical support in the development of research proposals and grant applications to sustain and expand registry programs. * *Support the design and implementation of studies involving public health and environmental health methodologies, including epidemiologicalanalysis. * *Lead the preparation and submission of manuscripts for peer-reviewed publications. * *Utilize existing environmental and health datasets to design and refine assessment tools (questionnaires) that accurately capture participant exposure and outcomes. * *Monitor and optimize the team's internal systems and processes to ensure maximum operational efficiency and high-quality outputs. * *Plan and deliver scientific workshops to synthesize diverse perspectives and guide strategic decision-making. * *Produce annual reports and presentations related to the Science Team for funding agencies, community partners, Congress and other stakeholders. * *Oversee administrative requirements for the Science Team, including managing project budgets. * *Build strong partnerships across the UH System, the Research Corporation of the University of Hawai'i (RCUH), and University Health Partners to navigate system and department processes and workflows for finance, human resources/hiring, policies/procedures, administration, and more. * *Manage staff to include scheduling and delegating tasks effectively; approving employee time sheets and expense reports as needed; and mentoring students, research assistants, and junior scientists by conducting regular check-ins, providing feedback, coordinating professional development opportunities, and overseeing work quality and productivity. * *Ensure strong communication and alignment between the Registry team, departmental leadership, and administrative staff. * *Evaluate the relationship between environmental factors and community health outcomes to inform future organizational strategy. * *Provide specialized technical support to other Registry efforts, such as Education and Outreach, as operational needs arise. * Other duties as assigned * Denotes Essential Functions Minimum Qualifications * Possession of a baccalaureate degree in public health, environmental health, health sciences, epidemiology, engineering, geology, geography, psychology, social work, public policy, or related field and 6 years of progressively responsible professional experience with responsibilities for public health, grant writing grant management, project management, personnel management, health sciences, epidemiology, health literacy health policy initiatives and or health science initiatives; or any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated. * Considerable working knowledge of principles, practices and techniques in the area of leading multi-institutional or community-based projects as demonstrated by the broad knowledge of the full range of pertinent standard and evolving concepts, principles and methodologies. * Considerable working knowledge and understanding of applicable federal and state laws, rules, regulations and theories and systems associated with human subjects research and best practices. * Demonstrated ability to resolve wide ranging complex problems through the use of creative reasoning and logic to accurately determine the cause of the problems and the resolution of the problems in an effective, innovative and timely manner. * Demonstrated ability to interpret and present information and ideas clearly and accurately in writing, verbally, and by preparation of reports and other materials. * Demonstrated ability to establish and maintain effective working relationships with internal and external organizations, groups, team leaders and members, and individuals. * Demonstrated ability to operate a personal computer, apply word processing, spreadsheet, and presentation software. * If applicable, for supervisory work, demonstrated ability to lead subordinates, manage work priorities and projects, and manage employee relations. Supplemental Minimum Qualifications * Proven record of peer-reviewed publications and successful grant proposal development. * Excellent mentoring abilities. * Demonstrated understanding of organizational processes and ability to implement processes to improve efficiency and gain organizational acceptance through basic change management skills. * Ability to travel for the purpose of attending meetings, training, and other activities in support of the project. Desirable Qualifications * Master's or Doctoral level degree in public health, health sciences, environmental health, epidemiology, engineering, geology, geography, public policy, psychology, social work, or related field. * Experience working with federally-funded projects within higher education systems in support of research and community programs. * Strong analytical skills, with experience in epidemiological data analysis and/or exposure assessment. * Understanding of the importance of cultural competence in the workplace and in the community impacted by the Red Hill water crisis. * Familiarity with the University of Hawai'i System. * Familiarity with the Department of Defense and military communities. * Familiarity with the Red Hill water crisis. * Knowledge of trauma-informed communication methods and sensitivity when presenting to communities impacted by traumatic events. * Knowledge of health and healthcare disparities with respect to issues specifically related to military families, Native Hawaiians, and underrepresented minorities in Hawaii. To Apply: Click on the "Apply" button on the top right corner of the screen to complete an application and attach required documents. Applicant must submit the following: * Cover letter describing how you meet the minimum qualifications and desirable qualifications * Names and contact information (including email addresses) of at least 3 professional references * Current curriculum vitae. * Copies of official undergraduate and graduate (as applicable) transcripts indicating degree conferred date with confidential information (i.e. social security number, date of birth) redacted. However, original official transcripts are required upon hire. Transcripts issued outside the United States of America require a course-by-course analysis with an equivalency statement from an agency having membership with the National Association of Credential Evaluation Services, Inc., verifying the degree equivalency to that of an accredited institution within the USA. Incomplete, late or unreadable applications will not be considered. Academic record/grade summaries will not be accepted. Diplomas and copies will not be accepted. Note: If you have not applied for a position before using NeoGov, you will need to create an account. Inquiries: Rosanna Weldon, ******************* EEO, Clery Act, ADA The University of Hawai'i is an Equal Opportunity Institution and is committed to a policy of nondiscrimination in employment, including on the basis of veteran and disability status. For more information, visit: ******************************************** Employment is contingent on satisfying employment eligibility verification requirements of the Immigration Reform and Control Act of 1986; reference checks of previous employers; and for certain positions, criminal history record checks. In accordance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, annual campus crime statistics for the University of Hawai'i may be viewed at: ***************************************************** or a paper copy may be obtained upon request from the respective UH Campus Security or Administrative Services Office. In accordance with Article 10 of the unit 08 collective bargaining agreement, bargaining unit members receive priority consideration for APT job vacancies. As a result, external or non BU 08 applicants may not be considered for some APT vacancies. BU 08 members with re-employment rights or priority status are responsible for informing the hiring unit of their status. Accommodation Request: The University of Hawai'i complies with the provisions of the Americans with Disabilities Act (ADA). Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the EEO coordinator directly. Determination on requests for reasonable accommodation will be made on a case-by-case basis. For further information, please refer to the following link: *********************************************************

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. **Objective:** Under the supervision of the Director or designee of Clinical Operations, responsible for overseeing the implementation of clinical studies to ensure that they are conducted according to the Investigational Plan and all applicable regulations. Provide clinical and technical expertise for Clinical Programs and Marketing Investigations, including on-site support. **Key Activities:** + Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with senior clinical trial sites regarding all logistics including contract agreements, support materials and training. + Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies. + Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and close out study visits to ensure compliance with protocols and GCP requirements. + Collaborates on clinical data processing in accordance with departmental SOPs and guidelines. + Verifies, reviews, and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensures that data changes are correctly implemented and captured in the database or data system. + Assists in the evaluation and analysis of clinical trial data to facilitate the completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions. + Assists in tracking study-specific payments. + Provides operational or workflow support to ensure that departmental and cross-functional systems and procedures are efficiently and correctly completed. + Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and Quality/Compliance. + Liaising between internal and external stakeholders to facilitate cooperation of others. + Conducts presentations of clinical information concerning specific projects. **Requirements:** + Bachelors degree in a health profession or science. Advanced degree preferred. + 5 years of on-going clinical trials experience. + Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements. + Knowledge of medical terminology. + Ability to effectively work independently. + Excellent verbal and written communication skills, computer proficiency (Word, Excel, Outlook), and data management experience. **We offer competitive salary & excellent benefits including:** + Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date + 401K Plan with company match and ongoing company contribution + Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time + Employee Stock Purchase Plan with company match + Employee Incentive Bonus + Tuition Reimbursement (select degrees) + Ongoing performance feedback and annual compensation review This position may be available in the following location(s): [[location_obj]] All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. For U.S. locations that require disclosure of compensation, the starting pay for this role is between $100,000.00 and $150,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation. Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Bausch + Lomb's Job Offer Fraud Statement (******************************************************************************************************** . Our Benefit Programs:Employee Benefits: Bausch + Lomb (***************************************** Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Full time Medical Customer Service Specialty. Practice specialty: Reproductive Endocrinology. Hours of operation: M \- F 7:30am to 4pm, Sat 7am to 12pm. "​Medical Customer Service Specialist needed for a fast\-paced Infertility practice in our Honolulu Office. The responsibilities for this position include but are not limited to the following: \- Answering multi\-line phones \- Greeting and checking\-in patients \- Collecting payment \- Assisting with patient text message responses \- Reconciling the fax box \- Providing excellent customer service to our patients." Requirements We are looking for a hard\-working, energetic, dependable, and punctual person. EXCELLENT interpersonal skills and attention to detail are a must. Must have good computer skills. Experience in an OB\/GYN\/Infertility office is a plus! Looking for a person with strong initiative, drive, and a willingness to learn! FT position M\-F. No covid vaccine is necessary. Benefits 401(k) 401(k) matching Dental insurance Flexible schedule Free parking Health insurance Life insurance Paid time off Vision insurance "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Apply Now","zsoid":"647497434","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Title","uitype":2,"value":"Healthcare Admin, Billing and Coding Specialist"},{"field Label":"Available To","uitype":100,"value":"Active Students;Graduates;Externs"},{"field Label":"Industry","uitype":2,"value":"Health Care"},{"field Label":"Salary","uitype":1,"value":"$17\-$20 per hour"},{"field Label":"City","uitype":1,"value":"Honolulu"},{"field Label":"State\/Province","uitype":1,"value":"Hawaii"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"96825"}],"header Name":"Fertility Institute of Hawaii","widget Id":"40**********072311","is JobBoard":"false","user Id":"40**********163003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"40**********160082","FontSize":"12","location":"Honolulu","embedsource":"CareerSite","logo Id":"eeqcw439641e48e25474f990f9dc53c6b2f12"}

Duties & Responsibilities: Independently organizes and manages activities and tasks associated with the conduct of early-phase industry-sponsored and investigator-initiated cancer clinical trials in the Ho‘ōla Early-Phase Clinical Research Center (EPCRC). Works with the clinical trial operation team to identify and inform candidate patients about available clinical protocols, enrolls consenting eligible patients and follows enrolled patients. Collects, documents, and enters data accurately and timely into case report forms, electronic medical record, and electronic data capture systems as required per protocol. Works with the clinical operation staff to ensure standard of care procedures are identified. Responsible for multiple functions needed to access, select and activate protocols and to maintain a high level of training, continuing education, quality control, and regulatory compliance for the enterprise. Works closely with the PI and his/her designee, with nurses and other staff in EPCRC, and with physicians/investigators to foster strong working relationships to ensure compliance with the conduct of industry and investigator-initiated research. Follows the standards and practices of the International Conference on Harmonization for Good Clinical Practices. Handles confidential information responsibly. Maintains confidentiality of patient information in accordance with Health Insurance Portability and Accountability Act (HIPAA). Maintains training as required in human subjects' research and all other requirements of UHP. Complies with all legal requirements and company policies. Performs all other duties as assigned. QUALIFICATION REQUIREMENTS Education/Training/Experience Minimum: Bachelor's Degree from an accredited four (4) year college or university in a health-related field, or an equivalent number of years of relevant healthcare experience. Relevant education, training, and professional experience in a health-related field may be considered in place of a degree. Three (3) years of experience working in health research/clinical trials including at least one year of oncology Preferred: Advanced Degree from an accredited college or university in a related field. Previous experience of early-phase industry-sponsored and investigator-initiated cancer clinical trials is preferred. Skills Knowledge Minimum: Works autonomously with minimal supervision, while also understanding the boundaries of the role, responsibilities, and experience. Seeks guidance and clarification from appropriate protocol-involved personnel when necessary. Demonstrated knowledge in human subjects' research and International Conference on Harmonization (ICH) Demonstrated knowledge in Good Clinical Practices (GCP) Demonstrated knowledge in Health Insurance Portability and Accountability Act (HIPAA) requirements . Understanding of research study designs and ethics. Knowledge of and experience with computers and software programs, including word-processing, spreadsheets, and databases. Specialized knowledge of specific cancer care sites conducting clinical trials or of job areas, such as education/training, regulatory, investigational drug accountability/storage, specimen collection/processing, database maintenance/reporting, and regulatory compliance auditing. Demonstrates strong organizational skills, attention to detail, accuracy, desire to learn, and timeliness of work. Strong and effective written and verbal communication skills, and interacts with supervisors, co-workers, and others respectfully and professionally at all times. BENEFITS Generous time off benefits 100% employee health and dental coverage and vision Flexible spending plan Retirement plan with up to 3% dollar-for-dollar company matching contributions 100% company paid group Life/AD&D/LTD insurance Employee assistance program (EAP) Pet Insurance, Prepaid legal with competitive rates UHP Hawai‘i is an EEO/AAP employer.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Title:Research Associate, Senior (Pacific Health Landscape Assessment) 0097562T Hiring Unit:College of Arts, Languages & Letters, Center for Pacific Islands Studies Band:B Salary:salary schedules and placement information Full Time/Part Time:Full-Time Month: 11-month Temporary/Permanent:Temporary Other Conditions: To begin approximately February 2026; continuation dependent on satisfactory performance, availability of funds and program needs. Duties and Responsibilities * *Lead the overall execution, administrative coordination, and strategic compliance of the research initiatives on Pacific Islands Policy Assessment, ensuring all milestones are achieved on time and within budget while maintaining strict ethical and reporting standards. * *Develop and maintain partnerships with project team, relevant stakeholders, and community members in research locations. * *Coordinate and manage all meeting logistics with Principal Investigator(s) (PI), project team, stakeholders, community members, etc. (including but not limited to scheduling, coordinating venues, developing agendas, coordinating regular meetings and emails, and distributing timely programmatic updates. * *Manage research operations and protocol implementation, ensuring ethical compliance and overseeing all data collection (primary/secondary). * *Design collaborative stakeholder engagements using co-development and system mapping methods. * *Conduct desk-based research of health policies outside of Hawaii and in the Pacific Islands. * *Support PIs with the full scope of project success, to include tasks related to project visioning, development, implementation, and evaluation. * *Provide administrative tracking and oversight for project research, partnerships, and deliverables, including budget tracking. * *Lead the literature review, policy brief, and technical report writing as well as scholarly article development and presentations at conferences and community meetings. This includes analyzing and synthesizing data, writing, and revising. * *Supervise four (4) Graduate Assistants, coordinating their schedules, assigning responsibilities, and tracking project outputs through regular meetings. * *Coordinate all outreach activities for the project in consultation with PIs and Community Champions. * *Lead and coordinate travel logistics for visits to American Samoa and the Commonwealth of the Northern Mariana Islands (CNMI) for PIs and traveling team members, including finding flights, accommodations, locations for workshops, ground transportation, and other travel needs as they arise. * *Contribute to the research, education, outreach, and publications program at the Center for Pacific Islands Studies through service, developing new collaborative projects, expanding partnerships, and contributing to broader program sustainability. * Other duties as assigned. * Denotes Essential Function Minimum Qualifications: * Possession of a baccalaureate degree in Social or Natural Sciences, Public Health and Health Policy, or related field and 4 year(s) of progressively responsible professional experience with responsibilities for qualitative and quantitative research design, implementation, analysis, and publication; or any equivalent combination of education and/or professional work experience which provides the required education, knowledge, skills and abilities as indicated. * Considerable working knowledge of principles, practices and techniques in the area of public health and health policy research as demonstrated by the broad knowledge of the full range of pertinent standard and evolving concepts, principles and methodologies. * Considerable working knowledge and understanding of applicable federal and state laws, rules, regulations and theories and systems associated with undertaking health and health policy research. * Demonstrated ability to resolve wide ranging complex problems through the use of creative reasoning and logic to accurately determine the cause of the problems and the resolution of the problems in an effective, innovative and timely manner. * Demonstrated ability to interpret and present information and ideas clearly and accurately in writing, verbally and by preparation of reports and other materials. * Demonstrated ability to establish and maintain effective working relationships with internal and external organizations, groups, team leaders and members, and individuals. * Demonstrated ability to operate a personal computer, apply word processing software, and Microsoft Office - Word, Excel, PowerPoint. * If applicable, for supervisory work, demonstrated ability to lead subordinates, manage work priorities and projects, and manage employee relations. * Demonstrated ability to conduct qualitative research and familiarity with policy analysis. * Relevant experience working with target communities or living in a related regional context outside of the immediate area. * Two years of professional writing experience which includes prior proposals, technical/scientific research administrative/scholarly reports, grant writing, and/or journalism. * Two years of experience in implementing, managing or servicing complex projects in a government, higher education or similar environment. * Strong organizational skills and demonstrated ability to coordinate work timelines and outcomes with multiple collaborators and project stakeholders. * Demonstrated ability to work independently and efficiently under time constraints. * Ability to work evenings, weekends and/or holidays, and/or at off-site locations. * Ability to travel independently to national and international locations in a timely manner. Desirable Qualifications: * Masters or PhD in Pacific Islands Studies, Social Sciences, Natural Sciences or related field from a college or university of recognized standing. * Experience working on grant-funded research and stakeholder-driven projects. * Competency in a relevant Pacific language, in particular Chamorro or Samoan. To Apply: Click on the "Apply" button on the top right corner of the screen to complete an application and attach the following required documents: * A cover letter indicating how you satisfy the minimum and desirable qualifications, * Current resume, * Official transcripts (copies acceptable for application, but if selected, originals transcripts required upon hire), * Names of three (3) professional references (including phone number and e-mail addresses). Note: Please create a new account if this is your first time applying for a position using NEOGOV Inquiries: Alexander Mawyer,***************** EEO, Clery Act, ADA The University of Hawai'i is an Equal Opportunity Institution and is committed to a policy of nondiscrimination in employment, including on the basis of veteran and disability status. For more information, visit: ******************************************** Employment is contingent on satisfying employment eligibility verification requirements of the Immigration Reform and Control Act of 1986; reference checks of previous employers; and for certain positions, criminal history record checks. In accordance with the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, annual campus crime statistics for the University of Hawai'i may be viewed at: ***************************************************** or a paper copy may be obtained upon request from the respective UH Campus Security or Administrative Services Office. In accordance with Article 10 of the unit 08 collective bargaining agreement, bargaining unit members receive priority consideration for APT job vacancies. As a result, external or non BU 08 applicants may not be considered for some APT vacancies. BU 08 members with re-employment rights or priority status are responsible for informing the hiring unit of their status. Accommodation Request: The University of Hawai'i complies with the provisions of the Americans with Disabilities Act (ADA). Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the EEO coordinator directly. Determination on requests for reasonable accommodation will be made on a case-by-case basis. For further information, please refer to the following link: *********************************************************

Full time Phlebotomist position. Practice specialty: Fertility, OB, GYN. Hours of operation: Mon \- Fri 7 am\- 4 pm, Sat 7 am\- 12 pm. 8 hour day shifts mon\- fri, weekends as needed. "Responsibilities: \- Perform venipuncture and collect blood samples from patients \- Ensure proper patient identification and labeling of specimens \- Provide excellent patient service and ensure patient comfort during the blood draw process \- Monitor vital signs and assess patient condition before and after the procedure \- Follow aseptic technique and maintain a clean and safe working environment \- Process and prepare specimens for laboratory testing \- Perform laboratory techniques such as centrifugation, aliquoting, and labeling \- Adhere to established laboratory procedures and protocols \- Ability to be trained as an MA when not doing ohlebotomy and to help where needed" Requirements "Requirements: \- Certification or training as a phlebotomist \- Knowledge of anatomy, physiology, and medical terminology related to phlebotomy \- Proficient in venipuncture techniques and blood sampling procedures \- Strong attention to detail and accuracy in specimen collection processing \- Excellent communication skills and ability to interact with patients in a professional manner \- Familiarity with laboratory techniques and equipment used in specimen processing \- Understanding of laboratory procedures and quality control measures Note: This job description is not intended to be all\-inclusive. The employee may perform other related duties as assigned by their supervisor." Benefits For full time employee: 401(k) 401(k) matching Free parking Health insurance Paid time off Vision insurance "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Apply Now","zsoid":"647497434","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Title","uitype":2,"value":"Clinical Medical Assistant"},{"field Label":"Available To","uitype":100,"value":"Graduates"},{"field Label":"Industry","uitype":2,"value":"Health Care"},{"field Label":"Salary","uitype":1,"value":"$20\-$21 per hour"},{"field Label":"City","uitype":1,"value":"Honolulu"},{"field Label":"State\/Province","uitype":1,"value":"Hawaii"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"96814"}],"header Name":"Fertility Institute of Hawaii","widget Id":"40**********072311","is JobBoard":"false","user Id":"40**********163003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"40**********780053","FontSize":"12","location":"Honolulu","embedsource":"CareerSite","logo Id":"eeqcw439641e48e25474f990f9dc53c6b2f12"}

The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk:** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Full time Medical Billing Assistant. Practice specialty: Reproductive Endocrinology. Hours of operation: M \- F 7:30am to 4pm, Sat 7am to 12pm. "Medical Billing Assistant needed in our Honolulu office. This is a great opportunity for a qualified person to join a young practice and grow with us. We are looking for a hard\-working, energetic, dependable and punctual person. EXCELLENT interpersonal skills and attention to detail are a must. Must have good computer skills. Pay is dependent on experience. Excellent benefits (401K, vacation and sick days). Full\-time in\-house position only Mon\-Fri, with occasional Sat hours. Willingness to cross train as a Medical Assistant is required, and perfect for the Medical Assistant who is familiar with basic billing functions and insurances. You do not need to be certified in medical\/billing and coding, as the position is more administrative billing in nature." Requirements "Necessary requirements: **One year of Medical billing\/insurance authorization experience is preferred, experience in an OB\/GYN\/Infertility office is a plus. Fantastic interpersonal skills. Exceptional attention to detail. Excellent computer skills. Able to multi\-task. Please send resume via e\-mail, to be considered for the opening." No covid vaccine is necessary. Benefits 401(k) 401(k) matching Dental insurance Flexible schedule Free parking Health insurance Life insurance Paid time off Vision insurance "}}],"is Mobile":false,"iframe":"true","job Type":"Full time","apply Name":"Apply Now","zsoid":"647497434","FontFamily":"Verdana, Geneva, sans\-serif","job OtherDetails":[{"field Label":"Title","uitype":2,"value":"Healthcare Admin, Billing and Coding Specialist"},{"field Label":"Available To","uitype":100,"value":"Graduates;Externs"},{"field Label":"Industry","uitype":2,"value":"Health Care"},{"field Label":"City","uitype":1,"value":"Honolulu"},{"field Label":"State\/Province","uitype":1,"value":"Hawaii"},{"field Label":"Zip\/Postal Code","uitype":1,"value":"96825"}],"header Name":"Fertility Institute of Hawaii","widget Id":"40**********072311","is JobBoard":"false","user Id":"40**********163003","attach Arr":[],"custom Template":"3","is CandidateLoginEnabled":false,"job Id":"40**********420020","FontSize":"12","location":"Honolulu","embedsource":"CareerSite","logo Id":"eeqcw439641e48e25474f990f9dc53c6b2f12"}

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs 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 inspection ready at all times. + 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 ICH-GCP, 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 Science 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. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **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 (Desired):** + 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 qualification (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. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**CRA and Sr CRA positions** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs 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 inspection ready at all times. + 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 ICH-GCP, 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 Science 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. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **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 (Desired):** + 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 qualification (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. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP is looking for a CRA/Sr CRA in the MidWest and West region of the United States!** **Oncology Experience required.** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs 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 inspection ready at all times. + 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 ICH-GCP, 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 Science 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. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **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 (Desired):** + 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 qualification (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. \#LI-SS1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**SE Region - Oncology experience required** The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **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 **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **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 \#LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Parexel FSP is looking for a CRA/Sr CRA in the US.** **Oncology Experience required. Cell therapy experience is strongly preferred.** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs 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 inspection ready at all times. + 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 ICH-GCP, 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 Science 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. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **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 (Desired):** + 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 qualification (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. **EEO Disclaimer** **Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.** \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **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 **Skills:** + 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. + 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. **Required Experience:** + 3+ years of direct Monitoring / CRA experience in a CRO or Pharma organization + 2+ years direct Oncology Monitoring / CRA experience in a CRO or Pharma organization + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree required **Other:** + Ability to travel as required. + Valid driving license per country requirements, as applicable \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.