Clinical research associate jobs in Claremont, NH - 46 jobs
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Lead Clinical Research Associate
Oracle 4.6
Clinical research associate job in Concord, NH
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 ClinicalResearchAssociate (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 clinicalresearch, and driving groundbreaking projects on a global scale!
**What you will do**
**As a Senior Lead ClinicalResearchAssociate 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 ClinicalResearchAssociates, 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 clinicalresearch experience.
+ **Clinicalresearch 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 ClinicalResearchAssociate 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 ClinicalResearchAssociates, 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 2d ago
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Clinical Scientist
Eliassen Group 4.7
Clinical research associate job in Concord, NH
**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 clinicalresearch 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 3d ago
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Parexel 4.5
Clinical research associate job in Concord, NH
**Job Purpose:** The Senior ClinicalResearchAssociate (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 ClinicalResearchAssociates
**Skills:**
+ Monitoring Experience: Minimum 3 years relevant experience in clinicalresearch 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 clinicalresearch 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 clinicalresearch (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.
$83k-113k yearly est. 43d ago
Senior Research Scientist - Clinical Neurophysiology
City of Hitchcock 4.0
Clinical research associate job in Lebanon, NH
The Dartmouth Health Department of Neurology is seeking a highly motivated PhD-level Clinical Neurophysiologist and Research Scientist to support and advance a variety of clinical and research programs at the Department of Neurology, with a particular focus on epilepsy and intraoperative neuromonitoring (IONM). This is a full-time, academic appointment located on our main academic campus.
The ideal candidate will combine expertise in neurophysiology and biomedical engineering with either prior experience in intraoperative neuromonitoring or a strong desire to train toward CNIM certification. A proven record of research productivity, including publications and grant support, is highly desirable.
Primary Responsibilities:
Clinical and Research Support
Provide biomedical engineering and software expertise to clinical and research programs, most notably in epilepsy.
Conduct multimodal data analysis and visualization of intracranial EEG.
Perform co-registration of pre-operative and post-operative imaging, quantitative EEG analysis, electrocorticography, functional mapping, and surgical planning support.
Intraoperative Neuromonitoring
Participate in the IONM program, including intraoperative case monitoring, troubleshooting, collaboration with surgeons and neurologists, and report preparation.
CNIM certification is preferred; however, full training will be provided for qualified candidates.
Additional Responsibilities Include:
Research Facilitation
Contribute to and organize interdisciplinary epilepsy-related research studies and proposals.
Advance the mission of The Epilepsy Center at Dartmouth through collaborative and independent research initiatives.
Education and Training
Train fellows, residents, medical students, nurses, and technicians in electrophysiological instrumentation, computerized monitoring, safety, biophysics, and related domains.
Requirements:
PhD in clinical neurophysiology, biomedical engineering, or a related field.
Proficiency in EEG instrumentation and computerized monitoring, evoked potentials, signal and image processing, data visualization, and statistical analysis.
Experience in intraoperative neuromonitoring; CNIM certification preferred, or willingness to complete training as an IONM technician.
Eligible for registration as a Medical Technologist.
An established track record of research productivity (publications and/or grant support) is preferred.
Please note: we are unable to sponsor a J1 waiver for this position.
What New Hampshire has to offer you:
Unmatched quality of life
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
Our Commitment to Belonging
At Dartmouth Health, we believe that the diversity of our patients, our people, and our community shows a strength we support and celebrate. We are committed to creating a welcoming environment for everyone to thrive, to fostering a culture of belonging, and to honoring all within our organization and the communities we serve. Consistent with our shared values and charitable mission, Dartmouth Health is better when we embrace each other with open minds and hearts, respect our differences, and champion fairness and acceptance.
About DHMC
Dartmouth Hitchcock Medical Center, the academic medical center for the Dartmouth Health system, is home to a breadth of clinical specialties, clinics, programs, facilities, and leading-edge research initiatives. As a source of hope and healing for our region, we are committed to delivering world-class care to everyone who enters our doors through a personalized approach that ensures every patient, family, and staff member is heard and respected.
DHMC's clinical excellence is exemplified by our expertise across a broad range of specialties and sub-specialties, and a growing body of clinicalresearch that translates into superlative patient care and positive outcomes. Our highly collaborative culture engages physician-researchers across the Medical Center, who integrate their research activities with a holistic care model that engages families in every aspect of diagnosis, treatment, and recovery. As an organization with deep roots in the Upper Valley community, we work to promote better health and health equity for all through a combination of support services, community partnerships, and population health programs that reflect the unique demographics and spirit of our region.
On our Lebanon campus-and in our work throughout the Dartmouth Health system-we make a solemn promise to advocate for our patients, promote effective collaboration among our colleagues, advance healthcare delivery through groundbreaking research, and help those we serve to lead brighter and healthier lives.
We can recommend jobs specifically for you! Click here to get started.
$90k-146k yearly est. Auto-Apply 41d ago
Senior Research Scientist - Clinical Neurophysiology
Dartmouth Health
Clinical research associate job in Lebanon, NH
The Dartmouth Health Department of Neurology is seeking a highly motivated PhD-level Clinical Neurophysiologist and Research Scientistto support and advance a variety of clinical and research programs at the Department of Neurology, with a particular focus on epilepsy and intraoperative neuromonitoring (IONM). This is a full-time, academic appointment located on our main academic campus.
The ideal candidate will combine expertise in neurophysiology and biomedical engineering with either prior experience in intraoperative neuromonitoring or a strong desire to train toward CNIM certification. A proven record of research productivity, including publications and grant support, is highly desirable.
Primary Responsibilities:
* Clinical and Research Support
* Provide biomedical engineering and software expertise to clinical and research programs, most notably in epilepsy.
* Conduct multimodal data analysis and visualization of intracranial EEG.
* Perform co-registration of pre-operative and post-operative imaging, quantitative EEG analysis, electrocorticography, functional mapping, and surgical planning support.
* Intraoperative Neuromonitoring
* Participate in the IONM program, including intraoperative case monitoring, troubleshooting, collaboration with surgeons and neurologists, and report preparation.
* CNIM certification is preferred; however, full training will be provided for qualified candidates.
Additional Responsibilities Include:
* Research Facilitation
* Contribute to and organize interdisciplinary epilepsy-related research studies and proposals.
* Advance the mission of The Epilepsy Center at Dartmouth through collaborative and independent research initiatives.
* Education and Training
* Train fellows, residents, medical students, nurses, and technicians in electrophysiological instrumentation, computerized monitoring, safety, biophysics, and related domains.
Requirements:
* PhD in clinical neurophysiology, biomedical engineering, or a related field.
* Proficiency in EEG instrumentation and computerized monitoring, evoked potentials, signal and image processing, data visualization, and statistical analysis.
* Experience in intraoperative neuromonitoring; CNIM certification preferred, or willingness to complete training as an IONM technician.
* Eligible for registration as a Medical Technologist.
* An established track record of research productivity (publications and/or grant support) is preferred.
* Please note: we are unable to sponsor a J1 waiver for this position.
What New Hampshire has to offer you:
* Unmatchedquality of life
* 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
Our Commitment to Belonging
At Dartmouth Health, we believe that the diversity of our patients, our people, and our community shows a strength we support and celebrate. We are committed to creating a welcoming environment for everyone to thrive, to fostering a culture of belonging, and to honoring all within our organization and the communities we serve. Consistent with our shared values and charitable mission, Dartmouth Health is better when we embrace each other with open minds and hearts, respect our differences, and champion fairness and acceptance.
About DHMC
Dartmouth Hitchcock Medical Center, the academic medical center for the Dartmouth Health system, is home to a breadth of clinical specialties, clinics, programs, facilities, and leading-edge research initiatives. As a source of hope and healing for our region, we are committed to delivering world-class care to everyone who enters our doors through a personalized approach that ensures every patient, family, and staff member is heard and respected.
DHMC’s clinical excellence is exemplified by our expertise across a broad range of specialties and sub-specialties, and a growing body of clinicalresearch that translates into superlative patient care and positive outcomes. Our highly collaborative culture engages physician-researchers across the Medical Center, who integrate their research activities with a holistic care model that engages families in every aspect of diagnosis, treatment, and recovery. As an organization with deep roots in the Upper Valley community, we work to promote better health and health equity for all through a combination of support services, community partnerships, and population health programs that reflect the unique demographics and spirit of our region.
On our Lebanon campus—and in our work throughout the Dartmouth Health system—we make a solemn promise to advocate for our patients, promote effective collaboration among our colleagues, advance healthcare delivery through groundbreaking research, and help those we serve to lead brighter and healthier lives.
Responsibilities
Qualifications
* Area of Interest:Physician
* FTE/Hours per pay period:1.00 - 1.00 - 40 hrs/week
* Shift:Day
* Job ID:27162
Dartmouth Health offers a total compensation package that includes a comprehensive selection of benefits. Our Core Benefits include medical, dental, vision and life insurance, short and long term disability, paid time off, and retirement plans. Click here for information on these benefits and more:Benefits | DHMC and Clinics Careers
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.
$86k-140k yearly est. 60d+ ago
Trial Master File (TMF) Specialist Oncology
Sumitomo Pharma 4.6
Clinical research associate job in Concord, NH
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 clinicalresearch 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
Research Coordinator III - Neurology
Dartmouth-Hitchcock Concord 4.2
Clinical research associate job in Lebanon, NH
The Department of Neurology is looking for an experienced ClinicalResearch Coordinator to help with managing current and new clinical trials. The person who qualifies for this role will be involved in startup, patient visits, regulatory activities, and overall management of a robust portfolio of clinical trials. The ClinicalResearch Coordinator III performs a full range of clinicalresearch duties at an advanced level and plans, organizes, leads, and performs comprehensive clinical trial duties for multiple or complex clinical trials, focusing on the overall productivity and success of the program. The expectation is to perform with limited supervision and actively participate in decisions regarding the clinicalresearch process, often leading teams. The impact of decisions of the ClinicalResearch Coordinator III are wide in scope affecting both internal and external partners. They cannot perform any tasks that by state or local law require a license to perform.
Responsibilities
Research Operations - Occasionally requiring tasks outside of defined operating hours:
* Mentors, onboards, trains and oversees new clinicalresearch coordinator staff on Good Clinical Practice (GCP), Human Subjects Protection (HSP) practices, the ethical conduct of research and a full range of clinicalresearch duties including regulatory compliance.
* May arrange/schedule required tests and other appointments.
* Independently executes all aspects of the study operations (subject management/regulatory) with minimal oversight from the investigator or their designee.
* Oversees subject management, such as data entry in Clinical Trials Management System (CTMS), scanning informed consents into Electronic Medical Records (EMR), and supporting data entry needs of the study.
* May carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision by investigator.
* May interview study participants about their medical history, medications, adverse events, demographics, and quality of life issues depending on complexity with review by principal investigator with collection of source data directly informed by medical records.
* May communicate with participants throughout the course of the study.
* May provide education and support to study participants and their families.
* Prepares and submits regulatory documents to study sponsors and any applicable regulatory agencies.
* May maintain study and regulatory documentation including working with the Institutional Review Board (IRB), ensuring all staff involved in the study are trained and that the training is appropriately documented.
Ethics & Participant Safety
* Supports the evaluation of staff and assure compliance with GCP,HSP practices and the ethical conduct of research.
* Assists and facilitates the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.
* Assists and facilitates with the development of documents related to safety and security.
* Communicates to research participants the difference between clinical activities and research activities and the risks and benefits of study participation.
Data and Informatics
* Trains others on the proper utilization of Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations.
* Scores tests, enters data and completes Case Report Forms (CRFs, eCRFs) accurately and according to protocol.
* Develops and implements data collection documents and instruments.
* Investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.
* Designs, develops or assists with development of Standard Operating Procedures (SOPs) for data quality assurance.
* Adheres to processes and runs queries, summaries and reports to monitor the quality of data.
* Monitors for and detects issues related to data capture, collection or management and suggests solutions.
* Recognizes trends related to data quality and escalates as appropriate.
* Uses required processes, policies and systems to ensure data security.
Leadership and Professionalism
* Understands and employs the professional guidelines and code of ethics related to the conduct of clinicalresearch and D-H and project specific training requirements.
* Travels to investigator meetings and study training sites.
* Provides guidance, oversight and mentoring to team members in skills and in performance expectations of service excellence, teamwork, communication, dependability and professionalism.
Site and Study Management
* Independently organizes and manages clinical trials and research studies.
* Conducts protocol reviews to assess the feasibility of potential studies.
* Participates in study site selection activities.
* Designs, develops and recommends recruitment and screening procedures and documentation.
* Composes informed consent forms and protocol abstracts.
* May participate in manuscript/abstract development.
* Maintains other study documents and study management tools.
* Provides expertise and guidance to the research team and investigators.
* Participates in the preparation of grants or study budgets for funding department research.
Communication and Team Science
* Serves as a liaison between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems.
* Supports and provides guidance to other members of the research team.
Portfolio and Program Development & Management
Qualifications
* Bachelors or equivalent years of experience
* Masters in relevant field preferred
* 4 years of relevant research experience
* Ability to travel as required
Required Licensure/Certifications
* BLS required within 30 days of hire date
* Certified ClinicalResearch Coordinator (CCRC-ACRP) or Certified ClinicalResearchAssociate (CCRA) or Certified ClinicialResearch Professional (CCRP-SCRA)
* Certified Good Clinical Practice (CGCP) within 30 days
* Human Subjects Protection (HSP) within 30 days
$48k-65k yearly est. Auto-Apply 5d ago
Clinical Secretary, Pediatrics- Full Time
Mount Ascutney Hospital and Health Center
Clinical research associate 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 9d ago
Research Coordinator
Dartmouth College 4.5
Clinical research associate job in Hanover, NH
Preferred Qualifications 2+ years of research coordination experience in academic or clinical settings Master's degree in related field Experience with digital health interventions or AI technologies Knowledge of mental health and wellness programs Background in managing large-scale research studies Experience with content development or quality assurance Familiarity with data analysis tools and techniques Knowledge of HIPAA compliance and research ethics Experience in academic research settings Background in program evaluation Familiarity with behavioral health interventions
$51k-63k yearly est. 60d+ ago
Clinic Coordinator - Physical Therapist
Engage Senior Therapy
Clinical research associate job in Concord, NH
At Engage Senior Therapy, we specialize in providing on-site physical, occupational, and speech therapy services to senior living communities across Southern New Hampshire and Greater Boston. Taking care of seniors is important work, and we're proud to support their well-being and quality of life through compassionate, expert care that achieves meaningful results.
We are looking for passionate and driven professionals who bring the best of themselves to everything they do. If you are ready to make a meaningful impact in a setting that fosters clinical excellence, career growth, and teamwork, check out our open positions and apply now!
Are you ready to make a meaningful impact in the lives of seniors? Engage Senior Therapy is seeking a dedicated
Physical Therapist to join our team as Clinic Coordinator,
delivering compassionate care at Assisted Living Facilities in the
Concord and Allenstown, NH Region
. This is your chance to empower the geriatric and senior population to regain strength, mobility, and independence while working in a supportive, team-oriented environment.
About the Role
As Clinic Coordinator, you will lead day-to-day operations of up to two clinics, ensuring each clinics' growth, profitability, and high-quality care delivery. You'll mentor a clinical team while managing your own patient caseload.
Responsibilities include:
Patient Care
Provide one-on-one physical therapy sessions
Develop individualized care plans and treat patients through all therapy phases, using evidence-based approaches to restore optimal function.
Complete daily patient care, progress, and discharge notes.
Attend weekly case management meetings with the care team and communicate continuously with referring physicians and referral sources.
Ensure documentation, clinical logs, and checklists follow Engage's policies and procedures.
Handle patient, family member, or DPOA questions, concerns, or complaints, collaborating with internal leadership to resolve any issues.
Staff Management
Lead and supervise clinical staff (PTs, PTAs, OTs, OTAs, SLPs), ensuring high performance and a supportive work environment.
Create and lead annual staff performance reviews, providing ongoing feedback and mentorship.
Participate in hiring, training, and onboarding of clinical team members
Prepare and lead staff meetings, addressing any team issues.
Serve as a mentor or clinical instructor through Engage's New Grad Mentorship and Student Affiliation Programs.
Clinic Management
Manage clinic schedules and ensure appropriate patient appointments in coordination with the Director of Quality Assurance.
Prepare and submit weekly reports on KPIs, including visit rates, cancellations, and other metrics.
Oversee the maintenance and cleanliness of the facility.
Develop ideas for new program initiatives and assist with their implementation.
Address any incidents involving patients, visitors, or staff, and ensure compliance with Medicare, state, and federal regulations.
Why Engage?
At Engage, we foster a humble, supportive, team-based culture focused on work-life balance and professional growth. We offer:
401(k) with a match
4 weeks of accumulated time off
6 paid holidays
Bonus Incentive Plan
Competitive compensation and benefits package
Continuing Education Reimbursement of up to $1000 annually
Medbridge subscription for unlimited online CEUs
Medical, Dental, and Vision Insurance
Short- and Long-Term Disability Insurance
Flexible work schedule
About You:
2+ years as a physical therapist in a senior therapy setting
Previous leadership experience
Excellent patient care and communication skills
Ability to multitask and provide an exceptional patient experience
Passion for patient outcomes and the ability to motivate a team
Knowledge of clinic KPIs, reporting, and analysis
Proficiency in Google Docs, Sheets, and/or Microsoft Word, Excel
Graduate of an accredited physical therapy program
Active or pending NH state license to practice physical therapy
At Engage, we invest in a culture of inclusion and positivity and encourage all to apply to our open roles. You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Engage is a proud member of Fusion Physical Therapy Partners.
$53k-74k yearly est. Auto-Apply 3d ago
Clinic Coordinator - Physical Therapist
Fusion Physical Therapy Partners
Clinical research associate job in Concord, NH
At Fusion Physical Therapy Partners, we believe that great things happen when we work together. We are a network of New England-based private practices committed to excellence and driven to continually innovate and improve. We're reshaping the future of physical therapy and setting new standards for patient care and clinic success.
Are you ready to make a meaningful impact in the lives of seniors? Engage Senior Therapy is seeking a dedicated
Physical Therapist to join our team as Clinic Coordinator,
delivering compassionate care at Assisted Living Facilities in the
Concord and Allenstown, NH Region
. This is your chance to empower the geriatric and senior population to regain strength, mobility, and independence while working in a supportive, team-oriented environment.
About the Role
As Clinic Coordinator, you will lead day-to-day operations of up to two clinics, ensuring each clinics' growth, profitability, and high-quality care delivery. You'll mentor a clinical team while managing your own patient caseload.
Responsibilities include:
Patient Care
Provide one-on-one physical therapy sessions
Develop individualized care plans and treat patients through all therapy phases, using evidence-based approaches to restore optimal function.
Complete daily patient care, progress, and discharge notes.
Attend weekly case management meetings with the care team and communicate continuously with referring physicians and referral sources.
Ensure documentation, clinical logs, and checklists follow Engage's policies and procedures.
Handle patient, family member, or DPOA questions, concerns, or complaints, collaborating with internal leadership to resolve any issues.
Staff Management
Lead and supervise clinical staff (PTs, PTAs, OTs, OTAs, SLPs), ensuring high performance and a supportive work environment.
Create and lead annual staff performance reviews, providing ongoing feedback and mentorship.
Participate in hiring, training, and onboarding of clinical team members
Prepare and lead staff meetings, addressing any team issues.
Serve as a mentor or clinical instructor through Engage's New Grad Mentorship and Student Affiliation Programs.
Clinic Management
Manage clinic schedules and ensure appropriate patient appointments in coordination with the Director of Quality Assurance.
Prepare and submit weekly reports on KPIs, including visit rates, cancellations, and other metrics.
Oversee the maintenance and cleanliness of the facility.
Develop ideas for new program initiatives and assist with their implementation.
Address any incidents involving patients, visitors, or staff, and ensure compliance with Medicare, state, and federal regulations.
Why Engage?
At Engage, we foster a humble, supportive, team-based culture focused on work-life balance and professional growth. We offer:
401(k) with a match
4 weeks of accumulated time off
6 paid holidays
Bonus Incentive Plan
Competitive compensation and benefits package
Continuing Education Reimbursement of up to $1000 annually
Medbridge subscription for unlimited online CEUs
Medical, Dental, and Vision Insurance
Short- and Long-Term Disability Insurance
Flexible work schedule
About You:
2+ years as a physical therapist in a senior therapy setting
Previous leadership experience
Excellent patient care and communication skills
Ability to multitask and provide an exceptional patient experience
Passion for patient outcomes and the ability to motivate a team
Knowledge of clinic KPIs, reporting, and analysis
Proficiency in Google Docs, Sheets, and/or Microsoft Word, Excel
Graduate of an accredited physical therapy program
Active or pending NH state license to practice physical therapy
Fusion Physical Therapy Partners and our associatedclinics are proud to
invest in cultures of inclusion and positivity and encourage all to apply to our open roles. You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
$53k-74k yearly est. Auto-Apply 45d ago
Clinical Appeals Coordinator | Concord Hospital | Part Time
Concord Hospital 4.6
Clinical research associate job in Concord, NH
The Clinical Appeals Coordinator is responsible for supporting Concord Hospital with claim appeal activities within the Revenue Integrity department. This involves a timely and accurate review of medical records in response to claim denials received from third party payers, Recovery Audit Contractors (RAC), Medicare Administrative Contractors (MAC), as well as medical necessity denials from other governmental and non-governmental payers and auditors. The Clinical Appeals Coordinator will evaluate opportunities for education and provide feedback to physicians the RCC Committee, and other relevant departments. Additionally, this person will serve as a clinical resource to the entire Revenue Management division.
Education
Bachelor's degree in Nursing from an accredited Nursing program.
Certification, Registration & Licensure
Experience
Minimum of five years' experience in utilization review and/or auditing in an acute-care hospital setting. Medicare audit and appeal background strongly desired. Must have solid understanding of Medicare levels of care (inpatient/observation). Experience applying Milliman and/or Interqual guidelines required. Familiarity with medical coding, reimbursement, and insurance practices required. Must possess excellent interpersonal, communication, and motivational skills, including the ability to communicate clearly and concisely, both orally and in writing. Ability to work collaboratively with individuals at all levels throughout the organization required. Strong facilitation and presentation skills required. Must use independent judgment in reviewing records to determine appropriate appeal action. Must be able to compose a persuasive appeal using clinical data, regulatory guidelines, evidence-based standards, and applicable legal statute. Strong organizational and time management skills required. Must be able to independently prioritize work. Strong critical-thinking and problem solving skills required. Must be flexible and comfortable in an environment with frequent changing demands and requirements. Strong computer skills required including MS Word and Excel.
Responsibilities
Performs audits on all assigned clinical denials.
Constructs all necessary appeals with payers for reconsideration of denied charges and/or services.
Identifies root cause of denials and provides education to Care Managers, Providers and Charge Departments as appropriate.
Acts as a clinical resource to Patient Financial Services and other Concord Hospital departments for payment/charge issues and other clinical inquiries that may or may not be related to audits and appeals.
Takes responsibility for individual performance goals.
Performs other duties as assigned.
Concord Hospital is an Equal Employment Opportunity employer. It is our policy to provide equal opportunity to all employees and applicants and to prohibit any discrimination because of race, color, religion, sex, sexual orientation, gender, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status.
Know Your Rights: Workplace Discrimination is Illegal
Applicants to and employees of this company are protected under federal law from discrimination on several bases. Follow the link above to find out more.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, you may contact Human Resources at ************.
$49k-76k yearly est. Auto-Apply 60d+ ago
Sr. Clinical Research Associate - Oncology - FSP
Parexel 4.5
Clinical research associate job in Concord, NH
The Senior ClinicalResearchAssociate (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 clinicalresearch 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.
$83k-113k yearly est. 39d ago
Senior Research Scientist - Clinical Neurophysiology
Dartmouth Health
Clinical research associate job in Lebanon, NH
The Dartmouth Health Department of Neurology is seeking a highly motivated PhD-level Clinical Neurophysiologist and Research Scientist to support and advance a variety of clinical and research programs at the Department of Neurology, with a particular focus on epilepsy and intraoperative neuromonitoring (IONM). This is a full-time, academic appointment located on our main academic campus.
The ideal candidate will combine expertise in neurophysiology and biomedical engineering with either prior experience in intraoperative neuromonitoring or a strong desire to train toward CNIM certification. A proven record of research productivity, including publications and grant support, is highly desirable.
Primary Responsibilities:
Clinical and Research Support
Provide biomedical engineering and software expertise to clinical and research programs, most notably in epilepsy.
Conduct multimodal data analysis and visualization of intracranial EEG.
Perform co-registration of pre-operative and post-operative imaging, quantitative EEG analysis, electrocorticography, functional mapping, and surgical planning support.
Intraoperative Neuromonitoring
Participate in the IONM program, including intraoperative case monitoring, troubleshooting, collaboration with surgeons and neurologists, and report preparation.
CNIM certification is preferred; however, full training will be provided for qualified candidates.
Additional Responsibilities Include:
Research Facilitation
Contribute to and organize interdisciplinary epilepsy-related research studies and proposals.
Advance the mission of The Epilepsy Center at Dartmouth through collaborative and independent research initiatives.
Education and Training
Train fellows, residents, medical students, nurses, and technicians in electrophysiological instrumentation, computerized monitoring, safety, biophysics, and related domains.
Requirements:
PhD in clinical neurophysiology, biomedical engineering, or a related field.
Proficiency in EEG instrumentation and computerized monitoring, evoked potentials, signal and image processing, data visualization, and statistical analysis.
Experience in intraoperative neuromonitoring; CNIM certification preferred, or willingness to complete training as an IONM technician.
Eligible for registration as a Medical Technologist.
An established track record of research productivity (publications and/or grant support) is preferred.
Please note: we are unable to sponsor a J1 waiver for this position.
What New Hampshire has to offer you:
Unmatched quality of life
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
Our Commitment to Belonging
At Dartmouth Health, we believe that the diversity of our patients, our people, and our community shows a strength we support and celebrate. We are committed to creating a welcoming environment for everyone to thrive, to fostering a culture of belonging, and to honoring all within our organization and the communities we serve. Consistent with our shared values and charitable mission, Dartmouth Health is better when we embrace each other with open minds and hearts, respect our differences, and champion fairness and acceptance.
About DHMC
Dartmouth Hitchcock Medical Center, the academic medical center for the Dartmouth Health system, is home to a breadth of clinical specialties, clinics, programs, facilities, and leading-edge research initiatives. As a source of hope and healing for our region, we are committed to delivering world-class care to everyone who enters our doors through a personalized approach that ensures every patient, family, and staff member is heard and respected.
DHMC's clinical excellence is exemplified by our expertise across a broad range of specialties and sub-specialties, and a growing body of clinicalresearch that translates into superlative patient care and positive outcomes. Our highly collaborative culture engages physician-researchers across the Medical Center, who integrate their research activities with a holistic care model that engages families in every aspect of diagnosis, treatment, and recovery. As an organization with deep roots in the Upper Valley community, we work to promote better health and health equity for all through a combination of support services, community partnerships, and population health programs that reflect the unique demographics and spirit of our region.
On our Lebanon campus-and in our work throughout the Dartmouth Health system-we make a solemn promise to advocate for our patients, promote effective collaboration among our colleagues, advance healthcare delivery through groundbreaking research, and help those we serve to lead brighter and healthier lives.
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$86k-140k yearly est. Auto-Apply 41d ago
Research Coordinator II - Gastroenterology
Dartmouth-Hitchcock Concord 4.2
Clinical research associate job in Lebanon, NH
ClinicalResearch Coordinator II performs a full range of clinicalresearch duties at a skilled level and has a working knowledge of the clinicalresearch process and the regulations that govern it. The expectation is to perform progressively more complex and comprehensive clinicalresearch duties with an increasing level of independence, working closely with the Principal Investigator (PI). The ClinicalResearch Coordinator II works under the supervision of and at the direction of the PI or their designee. They cannot perform any tasks that state or local law require a license to perform.
Responsibilities
Research Operations - Occasionally requiring tasks outside of defined operating hours May arrange and/or schedule required tests and other appointments. Understands and supports all of aspects of the study operations (including subject management/regulatory) with oversight from the investigator or their designee. Primarily supports subject management, such as data entry in the Clinical Trial Management System(CTMS), scanning informed consents into EMR, and supporting data entry needs of the study. May carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision of investigator. May interview study participants about medical history, medications, adverse events, demographics, and quality of life issues depending on complexity with review by PI with collection of source data directly informed by medical records. May communicate with participants throughout the course of the study. May provide education and support to study participants and their families. Prepares and submits regulatory documents to study sponsors and applicable regulatory agencies. Maintains study and regulatory documentation.
May manage study tasks primarily related to working with Institutional Review Boards (IRBs) and study sponsors as well as Dartmouth-Hitchcock Medical Center (DHMC) regulatory committees. Ethics & Participant Safety Applies and implements Good Clinical Practice (GCP)/Human Subjects Protection (HSP) practices.Maintains familiarity with the ethical conduct of research and safeguards needed when conducting research. May assist in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.May develop or assist with the development of documents related to safety and security.May communicate with research participants regarding the difference between clinical activities and research activities, and the risks and benefits of study participation. Data and Informatics Utilizes the Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations Scores tests, enter data, and completes Case Report Forms (CRFs, eCRFs) accurately and according to protocol. Develops or assists with the development of data collection documents and instruments and procedures for data quality assurance.Monitors for and identifies potential issues related to data capture, collection or management and suggests solutions. Investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.Adheres to processes and runs queries, summaries and reports to monitor the quality of data.May be responsible for recognizing trends related to data quality and escalating as appropriate.Uses required processes, policies and systems to ensure data security. Leadership and Professionalism Understands and employs the professional guidelines and code of ethics related to the conduct of clinicalresearch and Dartmouth-Hitchcock (D-H) and project specific training requirements. May travel to investigator meetings or protocol specific training. May participate in new employee mentoring/training under the guidance of a supervisor or senior team member. Site and Study Management Organizes and manages clinical trials and research studies.Conducts protocol reviews to assess the feasibility of potential studies. Seeks out new research opportunities.Participates in study site selection activities.Collaborates with study investigators to develop recruitment and screening procedures.Designs and develops recruitment documentation.Composes informed consent forms and protocol abstracts. Maintains other study documents and study management tools.May participate in manuscript/abstract development.
Communication and Team Science Serves as a liaison between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems. Identifies and recognizes the respective roles of team members.Understands and upholds the importance of an interdisciplinary team and the value each member can bring to clinical studies.
Performs other duties as required or assigned.
Qualifications
* Bachelors and 2 years of relevant research experience OR equivalent years of experience
* Ability to travel as required
* SOCRA/ACRP Certification or eligible for certification preferred
Required Licensure/Certifications
* BLS certification within 30 days of hire date.
* Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.
$48k-65k yearly est. Auto-Apply 19d ago
Specialist, Clinical Business Operations, Oncology
Sumitomo Pharma 4.6
Clinical research associate job in Concord, NH
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
Research Coordinator I - Gastroenterology
City of Hitchcock 4.0
Clinical research associate job in Lebanon, NH
ClinicalResearch Coordinator I works closely with other research staff and is involved at a fundamental level to support basic administrative clinical trial tasks. The ClinicalResearch Coordinator I has no supervisory responsibilities and works under direct supervision of the Principal Investigator or designee. They cannot perform any tasks that by state or local law require a license to perform.
Responsibilities
Research Operations
May arrange/schedule required appointments.
Learns and supports all of aspects of the study operations (subject management/regulatory) with substantial oversight from the investigator or their designee.
Primarily supports subject management, such as subject visit preparation, performs data entry in the Clinical Trial Management System (CTMS), scans informed consents into Electronic Medical Record (EMR) and supports data entry needs of the study.
Regulatory Affairs
Assists with compiling and maintaining essential records and documents required by Dartmouth-Hitchcock Medical Center (DHMC) and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations, including timely Institutional Review Board (IRB) submissions meeting sponsor and departmental requirements.
Provides support to supervisor and IRB with regard to regulatory and sponsor-related issues.
Assists with maintaining accurate and timely sponsor communications regarding status of research studies.
Under the direction of the supervisor, assists DMHC investigators with regulatory processes.
Maintains basic current understanding of IRB and Dartmouth-Hitchcock Health (D-HH) Institutional processes.
Maintains and tracks on-site and off-site storage of required study records and assists with data entry and accurate use of a tracking system for maintaining required essential documents.
Assists with local and commercial IRB, including initial submissions, modifications, renewal applications, and study closeout procedures.
Assists with scheduling and coordination of site visits, participates in site visits as assigned and tracks and ensures action items noted during site visits are completed and closed.
Tracks all required essential regulatory documents according to International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines including but not limited to: investigators' Curriculum Vitae (CVs), medical licenses, Collaborative Institutional Training Initiative (CITI), clinical laboratory certifications, etc.
Ethics & Participant Safety
Adheres to the principles for the ethical conduct of research, and safeguards for protection of human subjects especially when conducting research with vulnerable populations.
Understands and prioritizes the safety of research participants.
Data and Informatics
Utilizes Electronic Data Capture (EDC) systems, technologies and software necessary for study operations.
Completes data entry related to test results and/or measures according to protocol, and appropriate to role. Completes paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
Assists with investigating incomplete, inaccurate or missing data and or documents to ensure accuracy and completeness of data; follows Standard Operating Procedures (SOPs) for data quality assurance.
Appropriately utilizes standard processes, policies and systems to ensure data integrity, attribution, and security.
Leadership and Professionalism
Understands and demonstrates the professional guidelines and code of ethics related to the conduct of clinicalresearch.
Completes all D-H and project-specific training requirements.
Site and Study Management
Assists with administrative tasks associated with clinicalresearch studies (e.g. document and supply management).
Maintains lab kits and creates and maintains regulatory and subject binders.
May participate in manuscript/abstract development.
Communication and Team Science
Communicates appropriately (written and orally) between stakeholders.
Assists with communications between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems.
Performs other duties as required or assigned.
Qualifications
Bachelor's degree or the equivalent combination of education and experience required.
Previous research experience preferred
Required Licensure/Certifications
BLS certification within 30 days of hire date.
Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.
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$44k-65k yearly est. Auto-Apply 20d ago
Research Project Coodinator
Dartmouth College 4.5
Clinical research associate job in Hanover, NH
Details Information Position Title Research Project Coodinator Position Number 0000000 Hiring Range Minimum $57,100 Hiring Range Maximum $71,570 Location of Position Lebanon, NH Dartmouth Health, Williamson Advertisement Text We will be hiring two individuals for two separate positions for this role.
As part of our work with the Environmental Influences on Child Health Outcomes (ECHO) Program, we are hiring a Research Project Coordinator to support the Department of Epidemiology at the Geisel School of Medicine at Dartmouth. We strive to achieve our mission to conduct rigorously constructed research and apply state-of-the-art and novel methods and technologies to advance the field of epidemiology and impact human health and disease. In collaboration with project leaders, the Research Project Coordinator will coordinate the implementation and ongoing activities for a large National Institute of Health (NIH) funded Environmental influences on Children's Health Outcome (ECHO) birth cohort study.
Position Purpose
To support the Department of Epidemiology at the Geisel School of Medicine at Dartmouth in achieving its mission to conduct rigorously constructed research and apply state-of-the-art and novel methods and technologies to advance the field of epidemiology and impact human health and disease. In collaboration with project leaders, the Research Project Coordinator will coordinate the implementation and ongoing activities for a large National Institute of Health (NIH) funded Environmental influences on Children's Health Outcome (ECHO) birth cohort study.
Required Qualifications
* Bachelor's degree in health or social sciences, or the equivalent combination of education and experience is required.
* 5 years' experience working as a study coordinator, recruiting and interviewing research participants, or comparable experience.
* Demonstrated ability to coordinate a complex research project with minimal supervision.
* Demonstrates a high degree of independence and responsibility for ensuring timely completion of project activities.
* Proficiency with Microsoft Suite and web-based applications.
* Ability to apply critical thinking and sound judgment to address open-ended problems.
* Superior verbal communication and writing skills.
* Proven ability to manage multiple competing priorities.
* Must complete educational requirements for Dartmouth Committee on the Protection of Human Subjects (IRB) upon hire and appropriate laboratory and safety training(s).
* Must have a valid driver's license and be willing to travel to other study sites in the region of the research study as needed.
Preferred Qualifications
* Master's degree in health or social sciences or the equivalent combination of education and experience.
* Experience with performing spirometry or pulmonary function testing (PFTs)
* Experience working with children.
FLSA Exempt Employment Category Temporary Part time Schedule
This position is late afternoons, evenings, and weekends only.
Department Contact for Recruitment Inquiries Jennifer Egner Department Contact Phone Number **************************** Department Contact for Cover Letter Jennifer Egner, AssociateResearch Director Contact's Phone Number ********** Equal Opportunity Employer
Dartmouth College is an equal opportunity employer under federal law. We prohibit discrimination on the basis of race, color, religion, sex, age, national origin, sexual orientation, gender identity or expression, disability, veteran status, marital status, or any other legally protected status. Applications are welcome from all.
Background Check
Employment in this position is contingent upon consent to and successful completion of a pre-employment background check, which may include a criminal background check, reference checks, verification of work history, conduct review, and verification of any required academic credentials, licenses, and/or certifications, with results acceptable to Dartmouth College. A criminal conviction will not automatically disqualify an applicant from employment. Background check information will be used in a confidential, non-discriminatory manner consistent with state and federal law.
Special Instructions to Applicants
Dartmouth College has a Tobacco-Free Policy. Smoking and the use of tobacco-based products (including smokeless tobacco) are prohibited in all facilities, grounds, vehicles or other areas owned, operated or occupied by Dartmouth College with no exceptions. For details, please see our policy. *********************************************************
Additional Instructions Quick Link ***********************************************
Key Accountabilities
Key Accountabilities
Interviewing and Data/Biospecimen Collection - 60%
* Implements the research activities at participating medical clinics/study sites, including distribution and completion of surveys, data collection and management, subject identification, recruitment, interviewing, and scheduling.
* Provides education and instruction to participants on informed consent, study materials, collection of samples, measurements, and follow-up processes according to protocols.
* Collects data in person and remotely with participating study families, including pulmonary function testing (spirometry), cognitive assessments, anthropometric and survey data according to established study protocols.
* Collects biospecimens from study participants according to established study protocols.
* Coordinates collection and delivery of samples with laboratory, clinics, hospital staff, and other study staff as needed.
* Conducts necessary follow-up activities as needed and coordinates with laboratory and other study personnel to ensure specimens and measurements are collected, processed, entered into databases, and delivered according to protocol.
* Enters accurate study data in established databases in a timely manner according to protocols.
* Develops and maintains working relationships with collaborating clinics and staff to ensure adherence to study protocols and current clinical best practices.
* Acts as a resource to collaborating clinics and staff.
* Maintains a high level of research professionalism to maintain participant engagement and retention.
Coordination - 20%
* Works closely with the principal investigator and research directors on the development of, revisions and updates to protocols, study materials, and supplies.
* Maintains close communication with the principal investigator, study research directors, and other study staff regarding study progress, processes, and the collection and delivery of samples.
* Assists study research directors with data monitoring and tracking activities, preparation of reports, Institutional Review Board (IRB) renewals and revisions, and coordination of other administrative activities as needed.
* Maintains study supplies, equipment, and materials.
* Coordinates mailings for study subjects, follows up with staff on missing forms and materials, and maintains a supply of materials for staff.
Data Management - 10%
* Ensures that data are successfully collected and managed.
* Ensures that subject and data confidentiality is maintained, and data integrity is maintained.
* Maintains accurate and efficient tracking system for study documents approved by IRB and assures protocol materials are up to date and distributed appropriately.
Medical Records - 5%
* May conduct medical record reviews according to study protocols and may act as a clinical resource to other study staff for medical record reviews.
* Maintains working relationships with medical and administrative staff to coordinate medical record review activities.
Miscellaneous - 5%
* Other study tasks as needed
* Demonstrates a commitment to diversity, inclusion, and cultural awareness through actions, interactions, and communications with others.
* Adheres to the most current public health recommendations regarding COVID-19, including symptom surveillance, screening questions, and personal protective equipment.
* - Demonstrates professionalism and collegiality through actions, interactions, and communications with others appropriate to an environment that is welcoming to all. -- Performs other duties as assigned
Applicant Documents
Required Documents
* Cover Letter
* Resume
Optional Documents
Supplemental Questions
Required fields are indicated with an asterisk (*).
* * How did you learn about this employment opportunity?
* Current Dartmouth employee (Please specify full name below)
* Word of mouth
* Mentioned on social, digital, or print media (e.g. LinkedIn feed, VOX, Valley News, listserv)
* ****************** email outreach (includes Job Alert notifications, marketing emails from Talent Acquisition)
* Recruiter (Please specify full name or event below)
* ability JOBS
* Chronicle of Higher Education
* Glassdoor
* Handshake
* HigherEdJobs
* HigherEdMilitary
* Indeed
* Inside Higher Ed
* LinkedIn's Job Board
* RecruitMilitary
* Dartmouth's Job Board (searchjobs.dartmouth.edu)
* Other (Please specify below)
* If you would like to add more information to your answer, please specify here:
(Open Ended Question)
$57.1k-71.6k yearly Easy Apply 60d+ ago
Clinic Coordinator - Physical Therapist
Engage Senior Therapy
Clinical research associate job in Concord, NH
Job Description
At Engage Senior Therapy, we specialize in providing on-site physical, occupational, and speech therapy services to senior living communities across Southern New Hampshire and Greater Boston. Taking care of seniors is important work, and we're proud to support their well-being and quality of life through compassionate, expert care that achieves meaningful results.
We are looking for passionate and driven professionals who bring the best of themselves to everything they do. If you are ready to make a meaningful impact in a setting that fosters clinical excellence, career growth, and teamwork, check out our open positions and apply now!
Are you ready to make a meaningful impact in the lives of seniors? Engage Senior Therapy is seeking a dedicated
Physical Therapist to join our team as Clinic Coordinator,
delivering compassionate care at Assisted Living Facilities in the
Concord and Allenstown, NH Region
. This is your chance to empower the geriatric and senior population to regain strength, mobility, and independence while working in a supportive, team-oriented environment.
About the Role
As Clinic Coordinator, you will lead day-to-day operations of up to two clinics, ensuring each clinics' growth, profitability, and high-quality care delivery. You'll mentor a clinical team while managing your own patient caseload.
Responsibilities include:
Patient Care
Provide one-on-one physical therapy sessions
Develop individualized care plans and treat patients through all therapy phases, using evidence-based approaches to restore optimal function.
Complete daily patient care, progress, and discharge notes.
Attend weekly case management meetings with the care team and communicate continuously with referring physicians and referral sources.
Ensure documentation, clinical logs, and checklists follow Engage's policies and procedures.
Handle patient, family member, or DPOA questions, concerns, or complaints, collaborating with internal leadership to resolve any issues.
Staff Management
Lead and supervise clinical staff (PTs, PTAs, OTs, OTAs, SLPs), ensuring high performance and a supportive work environment.
Create and lead annual staff performance reviews, providing ongoing feedback and mentorship.
Participate in hiring, training, and onboarding of clinical team members
Prepare and lead staff meetings, addressing any team issues.
Serve as a mentor or clinical instructor through Engage's New Grad Mentorship and Student Affiliation Programs.
Clinic Management
Manage clinic schedules and ensure appropriate patient appointments in coordination with the Director of Quality Assurance.
Prepare and submit weekly reports on KPIs, including visit rates, cancellations, and other metrics.
Oversee the maintenance and cleanliness of the facility.
Develop ideas for new program initiatives and assist with their implementation.
Address any incidents involving patients, visitors, or staff, and ensure compliance with Medicare, state, and federal regulations.
Why Engage?
At Engage, we foster a humble, supportive, team-based culture focused on work-life balance and professional growth. We offer:
401(k) with a match
4 weeks of accumulated time off
6 paid holidays
Bonus Incentive Plan
Competitive compensation and benefits package
Continuing Education Reimbursement of up to $1000 annually
Medbridge subscription for unlimited online CEUs
Medical, Dental, and Vision Insurance
Short- and Long-Term Disability Insurance
Flexible work schedule
About You:
2+ years as a physical therapist in a senior therapy setting
Previous leadership experience
Excellent patient care and communication skills
Ability to multitask and provide an exceptional patient experience
Passion for patient outcomes and the ability to motivate a team
Knowledge of clinic KPIs, reporting, and analysis
Proficiency in Google Docs, Sheets, and/or Microsoft Word, Excel
Graduate of an accredited physical therapy program
Active or pending NH state license to practice physical therapy
At Engage, we invest in a culture of inclusion and positivity and encourage all to apply to our open roles. You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Engage is a proud member of Fusion Physical Therapy Partners.
$53k-74k yearly est. 17d ago
Sr. Clinical Research Associate - FSP
Parexel 4.5
Clinical research associate job in Concord, NH
**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The ClinicalResearchAssociate (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.
How much does a clinical research associate earn in Claremont, NH?
The average clinical research associate in Claremont, NH earns between $46,000 and $104,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Claremont, NH