Clinical research coordinator jobs in Hawaii - 12 jobs

Piper Companies is seeking a Clinical Research Associate (CRA) for a contract position supporting a global leader in the medical device industry specializing in cardiology devices. The Senior Clinical Research Associate (CRA) will oversee clinical trial monitoring and compliance activities for cardiovascular studies in Honolulu, HI. Responsibilities of the Clinical Research Associate include: * Conduct site monitoring visits to ensure compliance with GCP, ICH, and regulatory guidelines. * Provide protocol training and maintain effective communication with study sites. * Assess site adherence to protocol and regulatory requirements, reporting any quality issues. * Support subject recruitment and adapt recruitment plans as needed. * Track study progress, including regulatory approvals, enrollment, and data collection. Qualifications for the Clinical Research Associate include: * Minimum of 2 years of onsite monitoring experience in medical device or cardiology trials. * Strong knowledge of GCP, ICH guidelines, and FDA regulations. * Proficiency in CTMS, EDC systems, and Microsoft Office Suite. * Excellent organizational and communication skills with experience in site management. * Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred). Compensation for the Clinical Research Associate: * Salary Range: $145,000 - $165,000/year (USD) This job opens for applications on 01/09/26. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: clinical research, clinical trials, GCP, regulatory compliance, clinical monitoring, cardiology devices, site management, protocol adherence, patient recruitment, adverse event reporting, clinical study, documentation, IRB submissions, clinical trial management, data analysis, quality assurance, clinical operations, SOP, FDA regulations, ICH guidelines, electronic data capture, cardiovascular trials, risk management, stakeholder management, project management, communication skills, collaboration, medical device, clinical data management, regulatory submissions, clinical research ethics, clinical study reports, budgeting, contract negotiation, time management, decision making, clinical trial protocols. #LI-MB1 #LI-REMOTE

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. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. 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_

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"}

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.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we've been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what's possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer, fuller lives. We are committed to building a foundation for our people to be successful, investing in their development and growth, and creating a diverse, inclusive culture that welcomes different perspectives, experiences and backgrounds. What You'll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support in a hospital setting, utilizing EP technology in the treatment of various cardiac arrhythmias. You will join a high-functioning, collaborative team, partnering closely with physicians and hospital staff to support the diagnosis and treatment of abnormal heart rhythms to achieve better patient outcomes. In this role, individuals will exercise independent judgment in planning, organizing, and performing day-to-day tasks. You will identify and routinely use the most effective, cost-efficient, and best business practices to execute processes, regularly communicating insights, feedback, and results to managers and team. Additional responsibilities include: Gaining foundational knowledge of EP through a structured training program with a strong emphasis on hands-on learning and practical application. Providing regional EP procedural case coverage in an Electrophysiology lab and/or operating room setting. Acting as a clinical interface between the medical community and the business. Demonstrating the ability to build and sustain credible clinical relationships with customers and sharing product expertise accordingly. Demonstrating a thorough command of all EP products, including technical details, software utilization, and capabilities. Providing engineering, sales, education, and clinical support on the safe and effective use of Abbott EP products, including cardiac mapping, diagnostic, and therapy systems. Supporting EP Sales Representatives in the following areas: Collaborating with sales personnel; Facilitating regional training seminars; Participating in clinical studies/data collection; Troubleshooting; and, Leading/supporting new product in-service trainings and/or demonstrations to physicians, nurses, and sales representatives. Continuously develops engineering, sales and technical skills aligned with the overall territory strategy, including learning from senior sales personnel and management. Staying up-to-date on the latest industry developments, regulatory requirements, and maintains strong knowledge of company and competitor products, market trends, and strategic goals. Providing management with feedback on market trends and customer insights to inform strategic decisions and guide next-generation product development. Participating in occasional travel for in-person instruction and live procedure coverage. Required Qualifications Bachelors Degree or equivalent experience. Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews. The base pay for this position is $50,700.00 - $101,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Support ServicesDIVISION:EP ElectrophysiologyLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:YesSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

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 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"}

**Job Purpose:** 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 sponsor 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. **Key Accountabilities:** **Oversight of 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 sponsor 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 SCP 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 SCP 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 sponsor's credibility, scientific leadership and in order to facilitate sponsor's 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 **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#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.

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_

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"}

**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.