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Clinical research coordinator jobs in Vermont - 15 jobs

  • Lead Clinical Research Associate

    Oracle 4.6company rating

    Clinical research coordinator job in Montpelier, VT

    With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
    $70.6k-141.2k yearly 6d ago
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  • Clinical Scientist

    Eliassen Group 4.7company rating

    Clinical research coordinator job in Montpelier, VT

    **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!_
    $130k-150k yearly 7d ago

  • Trial Master File (TMF) Specialist Oncology

    Sumitomo Pharma 4.6company rating

    Clinical research coordinator job in Montpelier, VT

    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_
    $72.5k-90.6k yearly 60d+ ago

  • Clinical Research Coordinator

    University of Vermont 4.4company rating

    Clinical research coordinator job in Burlington, VT

    Details Provide clinical coordinator support to the Vaccine Testing Center (VTC) team to facilitate efficient operation of clinical infectious disease research and clinical trials. Monitor subject enrollment, recruitment and scheduling of visits for multiple clinical trials, including close coordination with recruiters for advertising and scheduling. Assign work to clinical assistant(s) as appropriate. Interact with study volunteers, University of Vermont Medical Center clinicians and research staff, sponsor representatives, and laboratory staff. Support the preparation and management of study-specific and regulatory documents. Collect, maintain and report data from clinical research studies. Perform data entry, QA/QC and data analysis, maintaining the highest standards of Good Clinical Practice. Prepare data and safety reports and presentations on a monthly and semi-annual basis. Minimum Qualifications (or equivalent combination of education and experience) Bachelor's degree with scientific background and one to three years related experience required. Effective time management and organizational skills required. Exposure to clinical settings or clinical research required. Working knowledge of word processing, spreadsheet and database applications and internet resources required. Effective written and verbal communication skills required. Ability to pay close attention to detail with a high degree of accuracy required. Trained in Good Clinical Practice Guidelines (GCP) or ability to obtain required. Sound judgment in solving problems, prioritizing work tasks, and communicating with internal and external collaborators. Desirable Qualifications Demonstrated ability to work effectively as part of a team and with study subjects in a clinical research environment highly desirable. Working knowledge of Microsoft Office applications and Windows highly desirable. Anticipated Pay Range $21.58/hr - $24/hr Other Information Special Conditions A probationary period may be required, Contingent on continued funding, Occasional evening and/or weekends required (if non-exempt position, may result in overtime), This position is ineligible for telework due to the essential functions, Background Check required for this position FLSA Non-Exempt Union Position Yes, UVMSU Posting Details Position will be posted for a minimum of one week, after which it is subject to removal without notice. Job Location Burlington, Vermont, United States Job Open Date 12/11/2025 Job Close Date (Jobs close at 11:59 PM EST.) Open Until Filled No Our Common Ground Statement The University of Vermont is a welcoming, educationally purposeful community committed to creating an inclusive environment that embraces intellectual diversity and global perspectives. We seek to prepare students to be accountable leaders who will bring to their work a grasp of complexity, effective problem-solving and communication skills, and an enduring commitment to learning and ethical conduct. Members of the University of Vermont community embrace and advance the values of Our Common Ground: Respect, Integrity, Innovation, Openness, Justice, and Responsibility. Staff play a critical role in this effort and the successful candidate will demonstrate a strong commitment to UVM's mission and advancing Our Common Ground values through the execution of their job duties. Position Information Position Title Research Collaborator OC2 N Posting Number S5857PO Department COM Microbio & Molec Genetics/55120 Position Number 00025535 Percent of Full-Time 1.0 Standard Hours at 1.0 FTE 37.5 Term (months per year) 12 Supplemental Questions
    $21.6-24 hourly 9d ago

  • Clinic Coordinator

    Copley Health Systems 4.3company rating

    Clinical research coordinator job in Morrisville, VT

    Copley Hospital (located in Morrisville/Stowe, VT) has a robust multi-location Rehabilitation department. Copley Rehab, in Hardwick and Morrisville, are quaint clinics seeking a team member with outstanding customer service skills to work alongside highly qualified therapists. This individual would be the friendly face to greet patients, answer the phone, schedule new and recurring appointments, and keep the clinic flowing. They would utilize the hospital computer system scheduling in all clinic locations, check-in and check-out of all patients, ensure all necessary information is in the electronic medical record prior to the start of care, collect and process co-payments and manage the overall schedule for each therapist. This individual needs excellent communication skills to work with other hospital departments, referring providers and their office staff as needed to facilitate efficient scheduling and timely patient care. They would thrive on mutitasking to manage multiple calls at once, ensuring minimal wait times for patients arriving for care and performing technician duties, as needed, to support therapists and patient flow. Responsibilities may vary depending upon the clinic site of assignment. Performs other duties as assigned. Compliance with all applicable State and Federal laws, regulations, and policies governing the provision of health care. We pride ourselves on the team approach while providing outstanding customer service and superb clinic care. If you would like to work with a great team then we would love to talk with you! Come join our dynamic Rehabilitation team! We are looking for a Clinic Coordinator to primarily work in our fast-paced outpatient rehabilitation clinic. This position is Per Diem (FT/PT option available). Copley Hospital has a variety of shifts available across Full-Time, Part-Time, and Temporary needs. Please consider applying to discuss how your availability may align. Compensation: Negotiable. An offer of employment may vary based on factors such as experience, education, skill, internal equity, and market data. Responsibilities Utilizing the hospital information system, schedules outpatients according to the patient needs and preferences, and in accordance with department procedures, availability of staff and modalities, for all clinic sites. Schedules initial and recurring appointments. Provides all patients with a written appointment card or printed schedule. Maintains a call list and schedules patients as appointments become available. Calls patients to modify schedules based on therapist or supervisor request. Enters corrected patient demographic information into the hospital registration screen, and informs the Administrative Assistant of these changes. Enters patient charges and/ or codes into the hospital information system, including those requiring defined ICD10 codes. Organizes and transports supplies, co-payments and/or medical record documents between clinics and or other hospital departments in accordance with department procedures. Ensures appropriate inventory of supplies for the reception desk, and may also ensure inventory of clinical supplies. Communicates with patients and guardians regarding insurance verification, limits of therapy coverage, cancel no show policy and any other department procedures as instructed. Helps maintain patient waiting and reception areas clean, attractive and free of safety hazards. Informs management of potential infection or safety hazards. Actively with initiative works to maintain full and consistent therapist schedules through proactive and creative scheduling practices. Assists in tracking and managing patient cancellation and failures to attend scheduled appointments through appropriate communications with patients and prompt communications with therapists and managers. Reports to managers when episodes of non attendance reach pre defined thresholds for this. Greets all patients, visitors and other staff entering the department and responds to their needs appropriately. Communicates with department clinical staff regarding patients' reported needs or other communications in order to ensure the clinical staff have complete information related to patient schedules and patient status. Ensures that patient medical records are maintained in a confidential and organized manner until required by the clinical staff. Prints daily clinician schedules and pulls charts as needed. Answers the telephones in a timely and professional manner, and provides the caller with timely and appropriate follow up for his her needs. Utilizes all necessary features of the phone system including call transfers, voice message changes, etc. as required for efficient department operations. Participates in department meetings and inservices. Other dutes as assigned Qualifications Education Required: High School degree or equivalent. Education Desired Computer and/or business courses beyond the high school level. Experience Required: One to two years of clerical or technical experience in a hospital setting or related field. Experience using a computer for data entry, scheduling, or equivalent work type. Experience Desired: Experience using scheduling software. Multiple line telephone customer support experience. Experience in front-line customer support. Health care/Technician experience supporting the clinic work flow, or LNA experience. Skill Required: Excellent customer service, communication, computer, and organizational skills. Knowledge of medical terminology. Ability to remain calm under pressure. Ability to work as part of a cohesive team supporting multiple professionals and other co workers while following established department procedures, hospital policies and regulatory requirements.
    $44k-69k yearly est. Auto-Apply 60d+ ago

  • Sr. Clinical Research Associate - FSP

    Parexel 4.5company rating

    Clinical research coordinator job in Montpelier, VT

    **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.
    $84k-114k yearly est. 44d ago

  • Clinical Secretary, Pediatrics- Full Time

    Dartmouth Health

    Clinical research coordinator job in Windsor, VT

    Searching for an engaged Clinical Secretary who has experience working with Parents and Children. Answering incoming phone calls, scheduling appointments, processing referrals, performing outreach, working closely with Providers to provide a high level of care to our Pediatric Populations. Hours will be from 8:00am to 5:00 PM Monday through Friday and rotate the Evening Clinic on Tuesday Nights from 5:00PM to 7:00pm when needed. QUALIFICATIONS Education: High School Graduate or equivalent Experience: Prior secretarial experience in a medical setting preferred. On the job trainingavailable. Salary: Min- $17.00 / Mid: $21.68 / Max: $26.35 * Area of Interest:Administrative Support; * Work Status:Mon-Fri 8:00-17:00; * Employment Type:Full-time; * Job ID:3775 Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dartmouth Hitchcock Medical Center and Dartmouth Hitchcock Clinics comply with applicable Federal civil rights laws and do not discriminate on the basis of race, color, national origin, age, disability, or sex. We do not exclude or treat people differently because of race, color, national origin, age, disability, or sex.
    $50k-76k yearly est. 13d ago

  • Clinical Secretary, Pediatrics- Full Time

    Mount Ascutney Hospital and Health Center

    Clinical research coordinator job in Windsor, VT

    Job Summary: Searching for an engaged Clinical Secretary who has experience working with Parents and Children.# Answering incoming phone calls, scheduling appointments, processing referrals, performing outreach, working closely with Providers to provide a high level of care to our Pediatric Populations. Hours#will be from#8:00am to 5:00 PM Monday through Friday and rotate the Evening Clinic on Tuesday Nights from 5:00PM to 7:00pm when needed. QUALIFICATIONS Education: High School Graduate or equivalent Experience: Prior secretarial experience in a medical setting preferred. On the job training available. # Salary: Min-#$17.00 / Mid: $21.68 / Max: $26.35 Job Summary: Searching for an engaged Clinical Secretary who has experience working with Parents and Children. Answering incoming phone calls, scheduling appointments, processing referrals, performing outreach, working closely with Providers to provide a high level of care to our Pediatric Populations. Hours will be from 8:00am to 5:00 PM Monday through Friday and rotate the Evening Clinic on Tuesday Nights from 5:00PM to 7:00pm when needed. QUALIFICATIONS Education: High School Graduate or equivalent Experience: Prior secretarial experience in a medical setting preferred. On the job training available. Salary: Min- $17.00 / Mid: $21.68 / Max: $26.35
    $17 hourly 13d ago

  • Specialist, Clinical Business Operations, Oncology

    Sumitomo Pharma 4.6company rating

    Clinical research coordinator job in Montpelier, VT

    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_
    $72.5k-90.6k yearly 60d+ ago

  • Sr. Clinical Research Associate - Oncology - FSP

    Parexel 4.5company rating

    Clinical research coordinator job in Montpelier, VT

    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.
    $84k-114k yearly est. 43d ago

  • Paramedic Clinical Associate (Part-Time)

    Vermont State University 4.4company rating

    Clinical research coordinator job in Williston, VT

    VSC Non-bargaining Unit, Grade 12, Exempt Hours a Week: 12 Special Considerations: 10+ hour lab days Home Campus: Williston CHARACTERISTIC DUTIES & RESPONSIBILITIES Supervision, education and evaluation of students as assigned by the Program Director. Review and abide aby student handbook policies. Attend scheduled in-service meetings and department meetings as scheduled. Collaboration with faculty and staff to ensure that syllabi are being followed, learning objectives are being met, and formative and summative evaluation strategies are employed to enhance the learning process. Communicate effectively with students, staff and faculty. Work outside regular business hours might be expected. Occasional in state travel may be anticipated. SUPERVISION RECEIVED General supervision is received from the Program Director, Paramedicine Education. SUPERVISION EXERCISED None Bachelor's degree preferred and/or 2-4 years of experience in paramedic field or a combination of education and experience from which comparable knowledge and skills are acquired. Vermont Paramedic License or Vermont Registered Nurse License with EMS experience required. Knowledge of course content being delivered. Excellent verbal, interpersonal, and written communications skills. Strong analytical, problem-solving, and flexible decision-making capabilities. Team player with the ability to multi-task in a fast-paced work environment. Ability to work under strict deadlines in a fast -paced environment. Ability to work with all levels of students as well as internal faculty and staff. Ability to endure considerable walking, standing and lifting while instructing/supervising students. Ability to deal effectively with and represent the College to a broad range of individuals and groups within and outside of the College. All required immunizations must be up to date. Valid Vermont driver's license. This general outline illustrates the type of work which characterizes the job classification. It is not an all encompassing statement of the specific duties, responsibilities, and qualifications of individual positions assigned to the classification. Vermont State University is a part of the Vermont State Colleges System (VSCS). VSCS values individual differences that can be engaged in the service of learning. Diverse experiences from people of varied backgrounds inform and enrich our community. VSCS strongly encourages applications from historically marginalized and underrepresented populations. VSCS is an equal opportunity employer, in compliance with ADA requirements, and will make reasonable accommodations for the known disability of an otherwise qualified applicant. Please contact our HR office for assistance with accommodations at *******************************. NOTE: Any offer of employment is contingent upon the satisfactory results of a background check.
    $131k-186k yearly est. 60d+ ago

  • Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP

    Parexel 4.5company rating

    Clinical research coordinator job in Montpelier, VT

    **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.
    $84k-114k yearly est. 47d ago

  • Associate Provider (APRN or PA)- Walk-In Clinic

    Dartmouth Health

    Clinical research coordinator job in Windsor, VT

    The Department of Emergency Medicine is seeking an experienced Advanced Practitioner (APRN or PA) to provide diagnostic evaluation and management of minor medical complaints for children and adults, presenting to the Mt. Ascutney Hospital and Health Center. Primary responsibilities for all assigned patients include ordering diagnostic testing, performing procedures within the advanced practitioner’s scope of practice, prescribing medications, directing the administration of medications by nursing staff. What MAHHC has to offer you: * Inclusive and collegial environment * Established patient base * Comprehensive compensation, benefits, and relocation * Dedicated CME time and funds * Ties to the Dartmouth Hitchcock Academic Medical Center and Geisel Medical School What Vermont has to offer you: * Four seasons and an outdoor lifestyle * Access to major cities and airports * Proximity to mountains and hiking trails * Driving distance to the seacoast/ocean * Abundance of local lakes for boating and swimming * Tax-free shopping in the neighboring state of NH! About the Windsor, VT Area: Located in the beautiful Upper Valley and situated between the Green and White Mountains, our practice is just two hours from Boston, MA, and Burlington, VT. We are surrounded by natural beauty and outdoor activities, a quaint downtown, and unique shopping experiences. This area is one of the most beautiful locations in New England. With lakes close by, as well as cycling, skiing and hiking opportunities, it offers the perfect opportunity for enjoying the outdoors in every season. About Mt. Ascutney Hospital and Health Center: Mt. Ascutney Hospital and Health Center is a critical access hospital in Windsor, Vermont founded in 1933 and winner of the Foster G. McGaw Prize for Excellence in Community Service. Mt. Ascutney Hospital and Health Center features 25 inpatient, medical-surgical beds and a renowned, 10-bed inpatient rehabilitation unit. The Hospital has a therapeutic pool and physical therapy department as well as acute care, transitional care, and hospice. In addition to a primary care base in multiple locations, specialty services include dermatology, gastroenterology, general surgery, oncology, ophthalmology, pain management, pediatrics, physical medicine and rehabilitation, podiatry, rheumatology, urology, and others. * Area of Interest:Physicians; * Work Status:Mon-Fri, Potential Weekend Coverage; * Employment Type:Part-time and Full-time; * Job ID:3732 Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dartmouth Hitchcock Medical Center and Dartmouth Hitchcock Clinics comply with applicable Federal civil rights laws and do not discriminate on the basis of race, color, national origin, age, disability, or sex. We do not exclude or treat people differently because of race, color, national origin, age, disability, or sex.
    $62k-151k yearly est. 60d+ ago

  • Clinical Associate - Nursing

    Vermont State University 4.4company rating

    Clinical research coordinator job in Williston, VT

    The Clinical Associate provides clinical instruction to the students, assisting them to apply concepts learned in the classroom to patient care in clinical areas. The Clinical Associate serves as a liaison between the College and clinical agencies. Vermont State University offers a 1+1+2 Practical Nursing Certificate, Associate Degree in Nursing, and RN to BSN online program that encourage nursing career ladder advancement. The first year is three semesters and culminates with a Certificate in Practical Nursing. Candidates who complete the first year are eligible to sit for the NCLEX PN exam. The second year, the Associate Degree in Nursing year, consists of two semesters and successful completion allows the graduate to sit for the NCLEX RN exam. Candidates must be LPNs to be considered for the second year of the program. The third and fourth years are completely online and allow a student to obtain a Bachelor's in Nursing Degree. Vermont State University delivers instruction at four traditional campuses (Bennington, Brattleboro, Randolph Center and Williston). There are also multiple distance sites that deliver instruction remotely to the following communities: Lyndonville, Middlebury, Newport, St. Albans, Springfield, White River Junction, and Keene, NH. Our students tend to be "non-traditional", many coming to our program with degrees and experience in other fields. While there is diversity among our students' backgrounds, there is a common goal to obtain nursing knowledge. Our graduates consistently score above the National Average on the NCLEX. Note: Additional information about the Nursing Program may be viewed at the Vermont State University College website at ************ Requirements: Qualified candidates will possess a Master's Degree in Nursing (MSN) with significant experience and must demonstrate excellent communication and teaching skills. Those currently enrolled in an MSN program to be completed within 3 years may be considered. A BSN will also be considered for Clinical Associate positions in our Practical Nursing program. We offer a competitive hourly rate and the opportunity to mentor future nursing students in a spacious, state of the art facility. These positions do not include a benefits package. FLSA: Exempt, Paid Hourly Part-time, up to 28 hours per week, $35 - $40 depending on education and experience. Applications will be accepted until positions are filled or by date specified. However, applications received after the initial screening will be considered at the discretion of the College. Vermont State University strongly encourages applications from members of ethnic minority groups and other under-represented backgrounds. Vermont State University is a part of the Vermont State Colleges System (VSCS). VSCS values individual differences that can be engaged in the service of learning. Diverse experiences from people of varied backgrounds inform and enrich our community. VSCS strongly encourages applications from historically marginalized and underrepresented populations. VSCS is an equal opportunity employer, in compliance with ADA requirements, and will make reasonable accommodations for the known disability of an otherwise qualified applicant. Please contact our HR office for assistance with accommodations at *******************************. NOTE: This job is subject to a fingerprint-supported criminal background check. Any offer of employment is contingent upon the satisfactory results of this check.
    $131k-186k yearly est. 5d ago

  • Dental Hygiene Clinical Associate-Williston

    Vermont State University 4.4company rating

    Clinical research coordinator job in Williston, VT

    The Clinical Associate will supervise practical application of theory in assigned clinical setting for the Dental Hygiene Program. Demonstrates dental hygiene care and procedures. Contribute to determination of daily student assignments in the clinical with review by the Clinical Coordinator. Conduct pre and post-conferences with students. Complete student evaluations. Attend scheduled department faculty and in-service meetings. Note: Additional information about the Dental Hygiene Program may be viewed at the Vermont Technical College website at ************ Requirements: Bachelor of Science degree in Dental Hygiene preferred or willingness to pursue. Three years of clinical practice experience. Active Vermont Dental Hygiene licensure at time of employment with no sanctions or restrictions required. Must have professional liability insurance coverage. Ability to endure considerable walking and standing while instructing/supervising students. Ability to establish and maintain effective working relationships. Ability to communicate effectively both orally and in writing. VSC Non-Bargaining Unit Grade: 12 FLSA: Exempt Part-time, up to 24 hours per week. Rate is $42.00/hr for a candidate with a BS degree and $45/hr for a candidate with a Masters degree Applications will be accepted until positions are filled or by date specified. However, applications received after the initial screening will be considered at the discretion of the College. Vermont Tech strongly encourages applications from members of ethnic minority groups and other under-represented backgrounds. Vermont Tech is an equal opportunity employer and does not discriminate against any individual because of race, color, religion, ancestry, place of birth, gender, gender identity, sexual orientation, national origin, age or veteran status, or against a qualified individual with a disability, or any other person whose status is protected under local, state or federal laws. In compliance with ADA requirements, we will make reasonable accommodations for the known disability of an otherwise qualified applicant. NOTE: This job is subject to a fingerprint-supported criminal background check. Any offer of employment is contingent upon the satisfactory results of this check.
    $42-45 hourly 60d+ ago

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