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Clinical Scientist
Patel Consultants Corporation 4.2
Clinical research associate job in Danbury, CT
Please only W-2 candidates.
Our client is looking for a Clinical Scientist who will be responsible for the following:
● Initiates and completes routine in vitro studies in an independent, efficient, and timely manner, with minimal supervision. Interprets the outcome of those experiments and proposes appropriate follow-up; troubleshoots effectively.
● Assists in the design and execution of non-routine cell-based in vitro and biochemical assays; conducts exploratory experiments with minimal supervision.
● Performs literature searches and extracts relevant information from literature and published protocols.
● Independently operates and is responsible for lab equipment; troubleshoots effectively.
● Communicates their own work effectively orally and in writing; contributes to writing protocols, procedures, and technical reports; provides input for scientific reports.
● Reports and treats data with a high level of integrity and ethics. Maintains accurate and up-to-date electronic lab notebooks.
● Complies with applicable regulations, performing all work in a safe and compliant manner; maintains proper records in accordance with Standard Operating Procedures and policies.
Skills: Skills ● Experience in aseptic animal tissue culture techniques and basic molecular biology techniques including nucleic acid extraction, RT-PCR, Western Blot, ELISA, transfection is required. Experimental design, execution, and interpretation in these areas will be required. ● Proven problem-solving ability and eagerness to learn. Ability to evaluate new technologies and assist in incorporating them into our research. ● Written and verbal communication skills: concise and accurate reporting of technical data and information ● Proficiency with computers and data analysis software such as Microsoft Excel and GraphPad Prism. ● Ability and willingness to work effectively in a highly collaborative environment.
Keywords:
Education: Master's Degree or Bachelor's Degree with 3+ years experience in related scientific discipline; pharmaceutical, biotechnology or CRO experience is highly desirable; non-PhD applicant required.
Required Skills ● ASEPTIC ANIMAL TISSUE CULTURE TECHNIQUES ● BASIC MOLECULAR BIOLOGY TECHNIQUES
$121k-154k yearly est. 1d ago
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Clinical Research Associate
Artech Information System 4.8
Clinical research associate job in Woodcliff Lake, NJ
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description
Medical Affairs - Global Oncology
Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments. Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.). Participate in development of protocol, case report form, CRF guidelines and other study documents. Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, Client SOPs and data issues. Reviews and approves monitoring reports and ensures tracking of ongoing site issues.
Minimum of college degree in a relevant discipline.
Bachelor's degree in relevant scientific discipline preferred.
CANDIDATES MUST HAVE MIN 3-5 years in-house in pharma company. Not just 3-5 years in CRO or onsite monitoring. We want to see associate in-house large pharma. Also, want to see experience in phase 3 global study trials in multifunctional areas. MUST HAVE experience in reviewing patient data and patient profiles.
**Oncology Experience Highly Preferred
Qualifications
BS
Additional Information
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
$46k-68k yearly est. 6h ago
Clinical Research Associate
Touro University 4.4
Clinical research associate job in Hawthorne, NY
Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinicalresearch nurses and team.
Responsibilities
Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols.
Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team.
Ensure compliance with the Good Clinical Practice guidelines in clinicalresearch.
Monitor study patients for adverse events in collaboration with clinical team and report as required.
Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements.
Qualifications
Education requirement: BS
Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments.
Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.
$48k-60k yearly Auto-Apply 60d+ ago
Clinical Research Associate
Millenniumsoft 3.8
Clinical research associate job in Franklin Lakes, NJ
ClinicalResearchAssociate Duration : 12 +months contract Start Time : 08:00 AM End Time : 05.00 PM Total Hours/week : 40.00 Qualifications:
The ClinicalResearchAssociate (CRA) is responsible for planning, negotiating, conducting, monitoring, and reporting on clinical trials.
The CRA is responsible for protocol development, site selection and qualification, preparing Informed Consent materials, contracting, training, site monitoring, and study document management.
The CRA collaborates with data management and statistics groups to ensure accuracy and integrity of study data.
The CRA is responsible for preparing reports of study results for investigators and internal development teams, assisting in preparation of regulatory submissions, and supporting publication activities.
The CRA will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities.
Responsibilities:
Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development. Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products.
Provide product development teams and other functions with technical and clinical expertise and support.
Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures.
Specific Responsibilities:
Develop the study design and protocol(s)
Screen, select, and qualify principal investigators and investigational sites
Conduct negotiations of clinical site agreements and contracts
Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials
Develop time schedules and budgets necessary to manage the clinical evaluations
Coordinate and plan availability of supplies and shipment of materials
Train clinical evaluation participants in study products and procedures.
Monitor sites to assure that the Protocol is understood and followed
Collect, review, analyze, and report data generated during clinical evaluations in a timely manner, through interactions with Clinical Database/Statistics
Communicate results of data analysis to each clinical center, project teams and applicable functions within BD, and actively support the publication and presentation of results by investigators
Support the reporting of performance data to regulatory authorities
Assumes responsibility for occasional special departmental projects
Anticipate 10% to 25% travel (primarily domestic; international travel a possibility
$50k-82k yearly est. 60d+ ago
Weights and Research Coordinator
R+L Carriers 4.3
Clinical research associate job in Maybrook, NY
Full-Time Monday-Friday, Various shifts
Salary range $60,000-$65,000 per yr
Come and experience the difference with R+L Carriers
Earn 1 week of vacation after 90 days of employment
Click here to learn more about our employee resorts
Company Culture
Requirements:
Any type of LTL experience preferred but not required
Ability to self-motivate and self-manage
Willingness to learn
Analytical skills
Computer proficiency
Able to work in a fast-paced environment
Excellent Benefits
R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC.
Click here ****************************
$60k-65k yearly Auto-Apply 1h ago
Clinical Research Associate
Nymc
Clinical research associate job in Hawthorne, NY
Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinicalresearch nurses and team.
Responsibilities
Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols.
Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team.
Ensure compliance with the Good Clinical Practice guidelines in clinicalresearch.
Monitor study patients for adverse events in collaboration with clinical team and report as required.
Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements.
Qualifications
Education requirement: BS
Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments.
Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.
$48k-60k yearly Auto-Apply 60d+ ago
Clinical Bench Scientist
Integrated Resources 4.5
Clinical research associate job in Pearl River, NY
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), ClinicalResearch, Rehabilitation Therapy and Nursing.
Job Description
The position requires
analyst participation in development and qualification of diagnostic ligand-binding assays
for candidate and post-market vaccines in support of various programs.
Responsibilities:
·
Generation and characterization of reagents, performance of experiments for development and qualification of assays, assay throughput for the pre-clinical studies and writing related procedures and reports.
·
As an integral member of the dynamic team, the incumbent must have a strong work ethic and be highly collaborative with the other group members.
·
All of the above includes
practicing laboratory safety at all times and efforts toward GLP compliance.
·
Perform all aspects of to support assay development and clinical testing.
·
Provide critical data review of clinical and non-clinical data. Collect, collate and analyze data on a per project basis to support troubleshooting, qualification and other lab projects.
·
Perform assays to support critical assay reagent testing, assay development/ troubleshooting.
·
Assist in ordering supplies from internal inventory and order/prepare reagents/supplies necessary for assay work.
·
Assist in updating and writing documents associated with assays, including information/data archiving, SOPs and status reports.
·
Satisfactorily completes all GLP and safety training in conformance with Departmental requirements.
·
Attend Power2Learn, corporate, and departmental training, as available.
·
Must meet Vaccine Research Medical Surveillance requirements
Qualifications
Education & Experience:
Bachelor's degree and 2 years relevant experience, or a Master's degree.
Technical Skills Requirements:
Laboratory experience in a biology, immunology and/or microbiology.
Knowledge of Luminex technology is a plus.
The incumbent will be trained on required Policies, Practices, and Procedures needed to support work responsibilities.
Proficiency in the
use of Word, Excel, PowerPoint and relevant scientific software is desirable
Additional Information
Kind Regards,
Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
$98k-121k yearly est. 6h ago
Clinical Research Scientist - Breast Cancer Franchise
Eli Lilly and Company 4.6
Clinical research associate job in Stamford, CT
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Overview:
The Development ClinicalResearch Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.
This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.
This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation.
Primary Responsibilities
* Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality.
* Demonstrate compliance with procedures and be accountable for compliance of team members.
* Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
* Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
* Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
* Collaborate with Global Patient Safety on risk management planning.
* Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
* Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
* Partake in data analysis, scientific dissemination, and preparation of final study reports.
* Analyze and contextualize clinical data to support decision-making and portfolio strategy.
* Contribute to strategy and innovation through cross-functional working groups.
* Support planning and execution of symposia, advisory boards, and other external engagements.
* Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
* Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
Scientific & Technical Expertise and Development
* Stay current with medical literature and scientific developments in breast oncology.
* Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
* Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
* Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.
Leadership & Professional Development
* Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists.
* Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual.
Basic qualifications:
* PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience
* 3+ years of clinicalresearch scientist experience/clinical trial experience
* Leadership experience
Additional Information/Preferences:
* Direct Line Leadership experience Breast cancer disease state knowledge/experience
* An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
* Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
* Strong communication, interpersonal, teamwork, organizational, and negotiation skills
* Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment.
* Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
* Fluent in English, verbal and written communication
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$83k-111k yearly est. Auto-Apply 60d ago
Clinical Research Scientist
Lancesoft 4.5
Clinical research associate job in Woodcliff Lake, NJ
Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits.
I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization.
Job Description
Description
The incumbent is responsible for, but not limited to the following:
• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
• Performs literature search and data analysis to address research questions
• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
• Assisting in database cleaning, review of study results, and interpretation of results
• Adhering to key performance indicators for clinical study development, conduct, and reporting
• Individual contributor with specialized knowledge
• Presents concepts, facts, and reports and advises on key trends and issues
• Troubleshooting routine site inquiries
• Work is completed under limited supervision
• Supports the planning, execution and reporting of clinical programs/trials
• May handle multiple protocols simultaneously
• Contributes to risk resolution by escalating and monitoring project risks
• Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
• A thorough understanding of clinicalresearch methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinicalresearch techniques in the oncology therapeutic area;
• Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Qualifications
Bachelor's Required. Doctoral (PharmD or PhD) degree preferred
Minimum of 5-7 years of experience in clinicalresearch in the pharmaceutical industry
Additional Information
All your information will be kept confidential according to EEO guidelines.
$78k-121k yearly est. 60d+ ago
Manager, Clinical Research
NS Pharma Inc.
Clinical research associate job in Paramus, NJ
Job Description
NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan.
Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements.
Essential Duties and Responsibilities:
Assist to plan, implement, manage and report for regional or global clinical studies.
Manage selection process of CROs for regional or global clinical studies.
Manage the performance of study vendors (e.g. CROs and central labs)
Manage activities for clinical site selection, investigator meetings and study initiation.
Oversight of patient recruitment and development of recruitment strategies and plans
Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.)
Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans.
Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols.
Coordinate negotiation of clinical trial contracts between investigational sites and CROs.
Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan.
Support coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites.
Implement project specific training program and training materials
Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes.
Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.).
As needed and required perform other tasks and functions.
Qualifications:
Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise.
Demonstrated ability to support the development and management of various aspects of the end to end study operational plan.
Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors.
Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies.
Ability to handle multiple tasks and prioritize.
Strong organizational, communication and presentation skills.
Team player, flexible, ability to adapt to change.
Must be able to travel within the US and outside of US 15-25% monthly and interact with Investigators in-person regarding the protocol and study drug.
Education and Experience:
Bachelor's Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience.
Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials.
Program and project management experience preferred.
Compensation And Benefits:
NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.
The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.
Other benefits include:
Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
Discretionary Bonus Programs and Long-term Incentive Plan
Retirement Savings 401k with company match
Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown.
Career Development, Progression and Training
Flexible Work Arrangement Programs
Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.
NS Pharma is an EEO employer.
$110k-135k yearly 27d ago
Clinical Research Scientist - Breast Cancer Franchise
Lilly 4.3
Clinical research associate job in Stamford, CT
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
**Position Overview:**
The **Development ClinicalResearch Scientist** (CRS) in the **Breast Cancer Franchise** will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies.
This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities.
This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation.
**Primary Responsibilities**
+ Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality.
+ Demonstrate compliance with procedures and be accountable for compliance of team members.
+ Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports.
+ Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management.
+ Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence.
+ Collaborate with Global Patient Safety on risk management planning.
+ Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions.
+ Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training.
+ Partake in data analysis, scientific dissemination, and preparation of final study reports.
+ Analyze and contextualize clinical data to support decision-making and portfolio strategy.
+ Contribute to strategy and innovation through cross-functional working groups.
+ Support planning and execution of symposia, advisory boards, and other external engagements.
+ Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts.
+ Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions.
**Scientific & Technical Expertise and Development**
+ Stay current with medical literature and scientific developments in breast oncology.
+ Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data.
+ Provide scientific consultation to medical affairs, health outcomes, and commercial teams.
+ Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia.
**Leadership & Professional Development**
+ Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists.
+ Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual.
**Basic qualifications:**
+ PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience
+ 3+ years of clinicalresearch scientist experience/clinical trial experience
+ Leadership experience
**Additional Information/Preferences:**
+ Direct Line Leadership experience Breast cancer disease state knowledge/experience
+ An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner)
+ Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission.
+ Strong communication, interpersonal, teamwork, organizational, and negotiation skills
+ Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment.
+ Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
+ Fluent in English, verbal and written communication
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ******************************************************* ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $308,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
\#WeAreLilly
$65k-107k yearly est. 60d ago
Clinical Study Coordinator/Specialist
Henkel 4.7
Clinical research associate job in Stamford, CT
**_About_** **_this_** **_position_** At Henkel, you'll be part of an organization that's shaping the future through innovation, sustainability and collaboration. With our trusted brands like Persil , 'all , Loctite , Snuggle , and Schwarzkopf and our cutting-edge technologies, you'll have countless opportunities to explore new paths and grow.
This position is with our Consumer Brands business unit - where we empower our employees to bring the best Laundry & Home Care and Hair products to people around the world.
_Henkel's R&D labs are planned to relocate to Trumbull, CT in the latter half of 2027. This position will move with the team. Candidates pursuing this opportunity will be working on-site at our Trumbull R&D center once the relocation is complete._
**Dare to learn new skills, advance in your career and make an impact at Henkel. **
**What you´ll do**
Business Context
+ Henkel CTI team (Consumer Technology & Insights) is looking for its new Clinical Study Coordinator to execute clinical studies for claims support and development of new products. If you are interested in supporting R&D needs with strong clinical data and outstanding innovations, then join our CTI community and be a key contributor at Henkel HCB!
Main Purpose of the Job
+ Steer and coordinate clinical studies to strengthen claims support for the HCB NA R&D Team.
Duties and Tasks
+ With the support of the Clinicals manager:
+ Executes well designed clinical studies per written protocols.
+ Interprets study results and recommends next steps, as necessary.
+ Provides topline results and final reports to study sponsors.
+ Ensures accurate data is generated during the conduct of the study.
+ Ensures test instruments are properly maintained and calibrated per standard operating procedures.
+ Highly customer oriented, interact daily with clinical study subjects. Conduct 1 on 1 interviews, collect medical history information, take vitals and apply beauty care products.
**What makes you a good fit**
Skills
+ Knowledge of Good Clinical Practices (GCP), Clinical Coordinator certification preferred
+ Consistently produces dependable and highly reliable results independently, thorough understanding of clinical test methods and interpretation of results
+ Ability to work in fluid environment, positive interactions with study subjects, that demands creativity with new product test methods
+ Good communication skills with product development, clinical subjects, etc, and desire to work in a team environment
+ Assists in clinical study subject recruitment and maintenance of recruiting database
Minimum Qualifications:
+ Education - Minimum of a B.S. degree and experience in study design and the conduct of clinical trials is preferred.
+ Experience - 1-3 years of relevant laboratory and industry experience
+ Skills - Consumer product R&D experience preferred, problem solving skills, communication and analytical skills, quick learner, strong interpersonal skills
+ Certifications and licenses -Certified Clinical Coordinator would be a plus but not required
+ Physical Requirements: The physical requirements of this job are consistent with an office job: significant amount of time at a computer station. On rare occasions there is a need to lift up to 20 pounds.
**Some benefits of joining Henkel**
+ **Health Insurance:** affordable plans for medical, dental, vision and wellbeing starting on day 1
+ **Work-Life Balance:** Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program
+ **Financial:** 401k matching, employee share plan with voluntary investment and Henkel matching shares, annual performance bonus, service awards and student loan reimbursement
+ **Family Support:** 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
+ **Career Growth:** diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement
The salary for this role is $70,000.00 - $80,000.00. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range and this range. This salary range may also be modified in the future.
Henkel does not accept unsolicited resumes from search firms or employment agencies. Unsolicited referrals and resumes are considered Henkel property and therefore, Henkel will not pay a fee for any placement resulting from the receipt of an unsolicited referral.
Henkel is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information, and other legally protected categories.
**JOB ID:** 25089848
**Job Locations:** United States, CT, Stamford, CT
**Contact information for application-related questions:** *****************************
Please do not use this email address for sending your application or CV. To apply, please click on the "Apply for this role" button below. Applications sent via e-mail will not be accepted.
**Application Deadline:** As long as the vacancy is listed on our Career Site, we are happy to receive your application
**Job-Center:** If you have an application already, you can create or log in to your accounthere (******************************************************************************************************************************************************** to check the status of your application. In case of new account creation, please use your email address that you applied with.
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How is work at Henkel
$70k-80k yearly Easy Apply 29d ago
Clinical: CF - North Haledon- PDN
Modivcare
Clinical research associate job in North Haledon, NJ
Apply today and become a valuable member of our Modivcare PDN Family!
Care Finders Total Care, a Modivcare Personal Care Service, is looking for an RN or LPN responsible for providing high-quality services to our home care private duty clients.
Position Spotlight...
Pay: LPN hourly rate $35 , RN hourly rate $40
Schedule: 2 days per week Mon & Tues 7:30a-5p
Area of Coverage: North, Central, South New Jersey
Full Time Benefits Package if eligible: See below more details.
You will...
Conduct initial home visits to assess patient needs.
Provide skilled nursing care following Patients Physicians Orders, Medication profile/sheet.
Document daily clinical notes and progress updates on the patient's clinical record
Communicate with a patient's physician and other healthcare professionals to ensure delivery of appropriate patient care.
We are excited to speak to someone with the following…
RN or LPN with at least 1 year of experience preferred.
Experience in Home Healthcare preferred.
Strong clinical judgment and critical thinking skills to make effective decisions with ability to adhere to Company/State/Regulatory requirements·
We value our team members and realize the importance of benefits for you and your family. Modivcare offers Full Time or variable hour employees working an averaged 30 hours per week a comprehensive benefits package including the following:
Medical, Dental & Vision Insurance
401(k) with a 6% match
Paid Time Off
Employee Assistance Program
Employee Discounts (retail, hotel, food, restaurants, car rental, and much more!)
Voluntary Term Life and AD&D Insurance
Legal Services Insurance
Short-Term and Long-Term Disability
Accident, Critical Illness & Hospital Indemnity Insurance
We live and lead by our Values…
• We treat everyone with dignity and RESPECT
• We earn the TRUST of our members, and each other
• We provide RELIABLE services that open doors
• We serve with courtesy and COMPASSION
• We prioritize SAFETY
• We communicate with purpose and TRANSPARENCY
Modivcare.
Because we care...always.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
$35-40 hourly 60d+ ago
Clinical Trials Coordinator - Unlicensed
The Stamford Hospital 4.8
Clinical research associate job in Stamford, CT
Participate and coordinate in clinicalresearch studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct of research trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed record keeping and regulatory compliance, report writing, and correspondence with investigators, sponsors/CROs, IRBs, and regulatory authorities. Responsible for the new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, and ancillary staff on available research studies, study treatment/ required activities, and use/ side effects of investigational study drug. Responsible for initial and continuing education for Good Clinical Practice compliance.
* Review institutional review board approved protocol and protocol documents prior to study activation and patient enrollment.
* Coordinate Study feasibility and initiation.
* Review patient charts, database records, and other sources to screen and identify potential subjects for inclusion in a study.
* Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
* Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol.
* Communicates study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance.
* Communicates with the Sponsor or its representatives, schedules and facilitates study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's representatives.
* Educate physicians, nurses, and ancillary staff regarding investigational product, trial activities, and requirements.
* Meet with potential subjects and their families to explain trial and treatment plan, and provide emotional and educational support.
* Collect pertinent information and data from study subject interviews, charts, study electronic devices and other sources.
* Meet with study sponsor and regulatory representatives to review and discuss conduct of the trial.
* Interacts with patients and families to ensure compliance with the protocol.
* Obtain written informed consent for subject to participate in trial prior to performing any study-related procedures.
* Coordinate research activities, including schedule appointments, laboratory tests, radiology and cardiology testing.
* Assists with maintaining accurate records of the receipt, inventory, and dispensation of study drug and materials.
* Assists the Director and Manager with protocol evaluation and feasibility.
* Responsible for speedy and adequate patient enrollment in all assigned studies and reflective of meeting department goals as proportionate to studies assigned.
* Compile and submit reports, documents, and correspondence to trial sponsor, institutional review board, and regulatory agencies.
* Oversees or submits new protocols to IRB and verifies that the proper document was received. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures.
* Trains less experienced team members.
* Complete protocol required case report forms accurately, completely, and in a timely manner in Electronic Data Capture system or paper format.
* Prepare or oversee the preparation of biologic specimens for shipment to study reference laboratory.
* Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows Stamford Hospital's Standard Operating Procedures, AAHRPP, HIPPA, and FDA guidelines for clinicalresearch, keeps updated with those procedures and/or guidelines, and complies with finance compliance policies and procedures.
* Responsible for the interdepartmental technical logistics for Device and Facility Use studies.
* Bachelor's Degree in scientific field preferred or a BA and 3 years research experience
* Clinicalresearch certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within 18-24 months of hire date.
* Human Research Subject Protection and Good Clinical Practice Certification
* OSHA training for handling hazardous biologic and chemical materials
$42k-58k yearly est. Auto-Apply 60d+ ago
Director, Clinical Scientist, Hematology
Regeneron Pharmaceuticals 4.9
Clinical research associate job in Tarrytown, NY
The Director Clinical Sciences, Hematology, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. The director will be responsible for managing a team of clinical scientists.
As a Director in Hematology, a typical day may include the following:
* May function as lead Clinical Scientist (CS) for program, and/or as delegate of Therapeutic area (TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam
* Line Manager for CS team and serves as key functional advisor or representative for the CS group; ensures alignment of process and procedures for CS across assigned assets/programs in alignment with TA expectation; Guides assigned Program teams/direct reports
* Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
* Applies advanced scientific expertise to propose, design, and execute clinicalresearch and development studies for early and late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature
* Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently; Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, IDMCs, Regulatory Authorities)
* Performs and mentors direct reports in clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
* Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies; Identifies areas of potential inconsistent data review
* Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of clinical data review plan and medical monitoring plans; ensures execution where appropriate for assigned studies/programs
This role may be for you if:
* Exhibits high level of skill in building team and mentoring direct reports
* Ability to lead activities within a matrix environment; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to influence within team and department and may influence across functionally
* Demonstrates exceptional initiative, creativity and innovation skills. Directly contributes to the development of innovations. Identifies opportunities to initiate operational changes
* Strong direct-line and cross-functional management, interpersonal and problem-solving skills
To be considered for this position, you must have a bachelor's degree required; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc). Additionally, ≥ 10 years of pharmaceutical clinical drug development experience. We are specifically seeking experience with lymphoma/hematology oncology, and a minimum of 4 years of direct and/or indirect management experience. Proven understanding of therapeutic disease areas and drug candidates including underlying disease biology, clinical manifestations and therapeutic standard practice, compounds including mechanism of action and drug landscape. Other levels considered depending on experience. #Hematology
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$202,000.00 - $336,600.00
$99k-121k yearly est. Auto-Apply 7d ago
Clinical Scientist
Global Channel Management
Clinical research associate job in Pearl River, NY
Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.
Qualifications
The Clinical Scientist will work collaboratively with the clinical
lead and team to execute the clinical program(s). Their primary
deliverable is to assist in the assist in planning, executing and
reporting of global clinical trials
The clinical
scientist support multiple tasks within the categories of 1) protocol
and study design, strategy and training, 2) data review and
interpretation, 3) study scientific integrity and oversight, 4) safety
review and communication, 5) regulatory document, study report and
publication preparation and review
Data review
Protocol Writing
BA/BS Degree in science or health-related field
3-5 years
Additional Information
$29/hr
12 months
$29 hourly 6h ago
Clinical Trials Coordinator
St. Joseph's Healthcare System 4.8
Clinical research associate job in Paterson, NJ
Under general supervision, coordinates clinicalresearch protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinicalresearch protocols and gathers data while maintaining patient confidentiality.t.
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinicalresearch or clinical trials coordination program management preferred.
$50k-67k yearly est. Auto-Apply 1d ago
Clinical Trials Coordinator - Unlicensed
Stamford Health 4.8
Clinical research associate job in Stamford, CT
Participate and coordinate in clinicalresearch studies conducted by supervising physician. Perform a variety of administrative duties to assist in the conduct of research trials. Supervises data manager and interns. Responsible for study initiation, subject recruitment, follow-up, data management, detailed record keeping and regulatory compliance, report writing, and correspondence with investigators, sponsors/CROs, IRBs, and regulatory authorities. Responsible for the new submission of protocols with subsequent amendments. Some participation in protocol writing. Educate research subjects, physicians, nurses, and ancillary staff on available research studies, study treatment/ required activities, and use/ side effects of investigational study drug. Responsible for initial and continuing education for Good Clinical Practice compliance.
Bachelor's Degree in scientific field preferred or a BA and 3 years research experience
Clinicalresearch certification (such as CCRC, CCRP or other certification approved by Director) preferred. If not yet certified, expected certification within 18-24 months of hire date.
Human Research Subject Protection and Good Clinical Practice Certification
OSHA training for handling hazardous biologic and chemical materials
Review institutional review board approved protocol and protocol documents prior to study activation and patient enrollment.
Coordinate Study feasibility and initiation.
Review patient charts, database records, and other sources to screen and identify potential subjects for inclusion in a study.
Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records and coordinating the collection and shipments of specimens as required by protocol.
Communicates study objectives and procedures to all relevant hospital units involved with the study, including the establishment of good rapport with the Principal Investigator and providing him/her with the required assistance.
Communicates with the Sponsor or its representatives, schedules and facilitates study Monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor's representatives.
Educate physicians, nurses, and ancillary staff regarding investigational product, trial activities, and requirements.
Meet with potential subjects and their families to explain trial and treatment plan, and provide emotional and educational support.
Collect pertinent information and data from study subject interviews, charts, study electronic devices and other sources.
Meet with study sponsor and regulatory representatives to review and discuss conduct of the trial.
Interacts with patients and families to ensure compliance with the protocol.
Obtain written informed consent for subject to participate in trial prior to performing any study-related procedures.
Coordinate research activities, including schedule appointments, laboratory tests, radiology and cardiology testing.
Assists with maintaining accurate records of the receipt, inventory, and dispensation of study drug and materials.
Assists the Director and Manager with protocol evaluation and feasibility.
Responsible for speedy and adequate patient enrollment in all assigned studies and reflective of meeting department goals as proportionate to studies assigned.
Compile and submit reports, documents, and correspondence to trial sponsor, institutional review board, and regulatory agencies.
Oversees or submits new protocols to IRB and verifies that the proper document was received. In addition, submits amendments of protocols to IRB and verifies that the required corrections were inserted following the established procedures.
Trains less experienced team members.
Complete protocol required case report forms accurately, completely, and in a timely manner in Electronic Data Capture system or paper format.
Prepare or oversee the preparation of biologic specimens for shipment to study reference laboratory.
Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. Follows Stamford Hospital's Standard Operating Procedures, AAHRPP, HIPPA, and FDA guidelines for clinicalresearch, keeps updated with those procedures and/or guidelines, and complies with finance compliance policies and procedures.
Responsible for the interdepartmental technical logistics for Device and Facility Use studies.
$41k-59k yearly est. Auto-Apply 46d ago
Clinical Trials Coordinator
St. Joseph's Health 4.8
Clinical research associate job in Paterson, NJ
Under general supervision, coordinates clinicalresearch protocols; interacts with sponsors, investigators, data coordinating centers, and core laboratory personnel as needed; ensures that the regulatory binders are complete and up-to-date; executes and adheres to the clinical trial research protocols; performs follow-up procedures and completes case report forms; prepares documents for IRB submission in compliance with all local, state, and federal regulations. Screens potential research patients for clinicalresearch protocols and gathers data while maintaining patient confidentiality.t.
Work requires the knowledge of theories, principles, and concepts normally acquired through completion of a Associates degree in Business, Public Health, or Health Education, and one to three years of previous work related experience. SOCRA and Patient Care Associate Adult Phlebotomy certification preferred. Previous experience in clinicalresearch or clinical trials coordination program management preferred.
$47k-64k yearly est. Auto-Apply 1d ago
Research Program Coordinator II, Research - Clinical Trials, Full Time, Day
The Valley Hospital 4.2
Clinical research associate job in Paramus, NJ
The Research Program Coordinator II (RPC II) provides administrative, operational, and programmatic support services to manage the research portfolio for The RPC II will join a highly collaborative team of investigators to examine specific diseases processes using electronic health record (EHR) data. Candidate must be able to independently conduct research including statistical analyses and prepare manuscripts and abstracts for dissemination.
Education
Bachelor's degree required, preferably in a healthcare, science, or data-focused field. Proficiency in Microsoft Word, Excel, PowerPoint, Teams and Outlook is required. Experience with statistical analysis and software such as SPSS, REDCap is preferred. Familiarity with electrophysiology clinical workflows, research practices, or electronic health records is desirable.
Experience
Bachelor's degree or equivalent plus 5 years of related experience, OR Master's candidate with 2 years of related experience and at least 1 year experience of data collection and analysis. Completion and maintenance of Human Subjects Research training/certifications via the CITI program.
Special Skills/Qualifications
Excellent verbal and written communication skills. This includes strong writing skills.
Computer proficiency with excellent data management and data analysis skills are also required. Experience with Redcap/SPSS and/or other statistical software programs is helpful.
Ability to communicate, interpret, share and present information to leadership, staff and lay audiences.
Strong organizational skills and appreciation for detail and quality is an essential skill for the position.
Achieves subject matter proficiency by reading and synthesizing pertinent literature.
Familiarity with topics pertaining to health care delivery, health policy, public health, and/or acute care.
Proficiency with the Microsoft Office Product Suite (including Word, Excel, PowerPoint, Outlook)
Job Location
Paramus 140 E Ridgewood Ave
Shift
Day (United States of America)
Benefits
Medical/Prescription, Dental & Vision Discount Program (Full Time/Part Time Employees)
Group Term Life Insurance and AD&D(Full Time Employees)
Flexible Spending Accounts and Commuter Benefit Plans
Supplemental Voluntary Benefits ( e.g. Short-term and Long-term Disability, Whole Life Insurance, Legal Support, etc.)
6 Paid Holidays, Paid Time Off (varies), Wellness Time Off, Extended Illness
Retirement Plan
Tuition Assistance
Employee Assistance Program (EAP)
Valley Health LifeStyles Fitness Center Membership Discount
Day Care Discounts for Various Daycare Facilities
SalaryJoining Valley Health System means becoming part of a dedicated team that values the highest quality of care in a supportive environment. In our commitment to high performance and reliability, we encourage and recognize exceptional individual performance through our industry leading compensation practices including a starting salary and benefits in accordance with your role, experience, education, and licensure. Actual individual salaries vary depending on these factors. The salary listed does not include other forms of compensation or benefits.Pay Range: $32.36 - $40.45 (per hour)
EEO Statement
Valley Health System does not discriminate on the basis of ancestry, age, atypical hereditary cellular or blood trait, civil union status, color, creed, disability, domestic partnership, gender, gender identity or expression, familial status, genetic information, liability for service in the Armed Forces of the United States, marital status, medical condition or illness, mental or physical handicap, national origin, nationality, perceived disability, pregnancy, race, refusal to submit to genetic testing or make available results of such tests, religion, sex, sexual orientation, veteran's status or any other protected basis, in accordance with all applicable Federal, State and Local laws. This applies to all areas of employment, including recruitment, hiring, training and development, promotion, transfer, termination, layoff, compensation, benefits, social and recreational programs, and all other conditions and privileges of employment.
How much does a clinical research associate earn in Cornwall, NY?
The average clinical research associate in Cornwall, NY earns between $44,000 and $101,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Cornwall, NY