Clinical research associate jobs in Greenburgh, NY - 110 jobs
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Clinical Research Associate
Clinical Research Scientist
Clinical Research Coordinator
Clinical Research Monitor
Study Coordinator
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
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Clinical Research Associate
Allen Spolden
Clinical research associate job in West New York, NJ
Responsible for providing ClinicalResearch support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinicalresearch functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
3+ years of clinicalresearch experience
Strong attention to detail
Ability to multi -task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self -motivated, assertive, and driven
$53k-83k yearly est. 60d+ 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 Research Scientist (EZIJP00002334)
Artech Information System 4.8
Clinical research associate job in Woodcliff Lake, NJ
Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.
Job 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, Client, 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
BS/MS
Additional Information
For more information, Please contact
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
$79k-116k yearly est. 1d ago
Clinical Research Scientist
Integrated Resources 4.5
Clinical research associate job in Woodcliff Lake, NJ
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
Title: ClinicalResearch
Scientist
Duration: 12 Months (Possibility of Extension)
Location Woodcliff lake NJ
Job Responsibilities:
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
Qualifications
Qualifications
Minimum of
2-5 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) or MD degree preferred
.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus
Thank you for your time and consideration. I look forward to hearing from you!
Kind Regards
Ruchi Kumari
Clinical Recruiter
Integrated Resources
, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE
|
GSA - Schedule 66
I
GSA - Schedule 621I
(DIRECT BOARD) #
732-844-8716
(F) 732-549-5549
LinkedIn:
https://www.linkedin.com/in/ruchi-kumari
Gold Seal JCAHO Certified ™
for Health Care Staffing
“INC
5
0
0
0
's
FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$77k-115k yearly est. 1d 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. 1d ago
Clinical Research Scientist
Mitsubishi Tanabe Pharma America 4.1
Clinical research associate job in Jersey City, NJ
Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Reporting to the Senior Director, Clinical Development, the ClinicalResearch Scientist will
provide
leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinicalresearch and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion.
The ClinicalResearch Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors.
He/she will provide clinicalresearch in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible.
Job Description
Prepare clinical-related documents with minimal supervision and routine documents independently as directed.
Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
submissions such as INDs.
Author abstracts and manuscripts for publication in peer-reviewed journals.
Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
Ability to prepare, present and defend complex aspects of protocol design and/or study data at
investigator and internal meetings.
Oversee and coordinate the collection of and/or collect pre-study documents
Participate in data review and discrepancy resolution, team meetings/presentations with increasing
levels of independence and support the Program Clinical Leader or Sr. Management as needed.
Assist in managing regulatory safety reporting with the following: SAE queries and follow-up,
annual reports, investigator brochures, ability to learn various databases.
Critically review and synthesize complex information from reviews of the scientific and clinical
literature.
Qualifications
Minimum 2-5 years of pharmaceutical industry clinical trial experience.
Experience in immunology or endocrinology therapeutic areas is a plus.
Primary experience with development of clinical trial protocols.
Medical or scientific writing experience a must and familiarity with clinically applied science or
pharmaceutical development.
Good understanding of FDA regulatory, ICH, and GCP requirements.
Excellent communication skills, written and verbal.
Superior interpersonal communication and the ability to work across company disciplines and functional units.
Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and a commitment to high quality and on-time deliverables are key success factors.
Willingness to travel up to 30% domestically and internationally.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.
At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
$75k-125k yearly est. 1d ago
Oncology CRA/Clinical Site Monitor (field-based) - NY/NJ
Astellas Pharma 4.9
Clinical research associate job in Jersey City, NJ
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This field-based position is based in either New York or New Jersey.
Purpose and Scope:
A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
Site Selection
Pre-trial assessment
Site level Study Participant recruitment/retention plans
Site Activation/Initiation
On-site and remote monitoring
Overall site relationship management in collaboration with other sponsor roles that interact with the site
Close-out activities
Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Responsibilities & Accountabilities:
Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
Develops meaningful site relationships through consistent collaborative communication and engagement.
May participate in site feasibility and/or pre-trial site assessment visits.
Attends/participates in investigator meetings as needed.
May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
Ensures site non-IMP study supplies are adequate for trial conduct.
Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
Oversees the appropriate destruction of clinical supplies.
Ensures site staff complete data entry and resolve queries within expected timelines.
Ensures validity and completeness of data collected at trial sites.
Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
Prepares trial sites for close out, conduct final close out visit.
Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
$67k-110k yearly est. 13h ago
Part-time Clinical On- Site Monitor
Berkeley College 4.7
Clinical research associate job in Woodland Park, NJ
Berkeley College, a career-focused institution of higher education, seeks a part-time Clinical On-Site monitor to observe and document the clinical procedures Surgical Technology and Surgical Processing Technician students perform in the clinical environment. This individual will also serve as the liaison between the clinical sites and the College.
Primary Duties and Responsibilities
Observe and document clinical procedures as performed in the clinical setting.
Monitor case specialties of Surgical Technology students.
Review clinical performance with each student.
Review weekly student self-evaluations and skill assessments and advise as appropriate.
Maintain clinical attendance logs.
Serve as a liaison between the College and clinical affiliate staff.
Meet with the Clinical Coordinator to discuss student performance.
Occasional administrative work to be performed at the Woodland Park, NJ, campus upon request of the School Dean and/or Clinical Coordinator.
Salary Range: $40-$45/hour
Job Location
The part-time staff position includes off-site visits to clinical sites as well as on-campus meetings and administrative work as requested by the School Dean and/or Allied Health Surgical Clinical Coordinator.
Educational Requirements
Be a graduate of an educational program in surgical technology accredited by a nationally recognized programmatic accreditation agency.
Possess a credential in the field of surgical technology through a national certification program that is accredited by the National Commission on Certifying Agencies (NCCA).
Training and/or Experience
Have a minimum of three years of documented experience in the operating room scrub role or as an instructor in surgical technology, or a combination of both, within the past five years.
Possession of a current unrestricted driver's license.
Possess a current CST certification.
Knowledge, Skills & Abilities
Knowledgeable in the competencies required for competent Surgical Technologists and Surgical Processing Technicians.
Knowledgeable about the program's evaluation of student learning and performance.
Skilled in Microsoft Office applications such as Word and Excel.
Knowledge of learning management systems is preferred.
Miscellaneous
Mileage, tolls, and parking will be paid to the part-time Clinical Site Monitor and will be based on the College's reimbursement policy. The maximum number of hours worked each week shall not exceed 20, unless prior approval is received.
Berkeley College is an Equal Opportunity Employer and considers applicants for all positions regardless of race, color, religion, creed, gender, age, national origin, marital and veteran status, disability, sexual orientation, gender identity or expression, or any other legally protected status. We believe in fostering tolerance, acceptance, and understanding in our community, by employing individuals who bring unique perspectives to the College.
$40-45 hourly 60d+ ago
Clinical Study Coordinator/Specialist
Henkel 4.7
Clinical research associate job in Stamford, CT
Consumer BrandsResearch & DevelopmentUnited States, Stamford, CT, CTFull TimeRegular **_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.
$70k-80k yearly Easy Apply 40d ago
Clinical Research Coordinator I (Yonkers, NY)
Care Access 4.3
Clinical research associate job in Yonkers, NY
Job Description
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The ClinicalResearch Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP.
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines.
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Patient Recruitment
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Other Responsibilities
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Attend Investigator meetings as required.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
Maintain effective relationships with study participants and other care Access Research personnel.
The Expertise Required
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
Bachelor's Degree preferred, or equivalent combination of education, training and experience.
A minimum of 1-year prior ClinicalResearch Coordinator experience required
Recent phlebotomy experience required
How We Work Together
Location: Position requires onsite work 5 days per week at the Yonkers, NY or Hoboken, NJ clinic.
Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives.
Physical demands associated with this position Include:
Walking-20%
Standing-20%
Sitting-20%
Lifting-20%
Up to 25lbs Overhead
Driving-20%
The expected salary range for this role is $55,000 - $85,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$55k-85k yearly 10d ago
Unblinded Clinical Research Coordinator II
DM Clinical Research
Clinical research associate job in Jersey City, NJ
Unblinded ClinicalResearch Coordinator DM ClinicalResearch, the largest privately-owned clinicalresearch organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded ClinicalResearch Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinicalresearch trials.
Duties & Responsibilities:
Compound and dispense prescribed IP.
Supervise and maintain records of all medications
Ensure compliance with study-specific blinding plans.
Provide consultative support regarding the preparation and dosing of drugs.
Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction.
Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials.
Understand and apply all applicable site procedures.
Ensure receipt and proper storage of IP and bioretention samples.
Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy.
Review protocols and provide input on clinical and pharmacy supply needs.
Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information.
Temperature reporting.
Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Foreign Medical Graduate is a plus
Pharmacy Technician Certification a plus
Experience:
Clinical Experience
Credentials:
LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant)
Knowledge and Skills:
Computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Excellent communication and customer service skills.
Outgoing personality Well-organized with attention to detail.
Must be able to multitask.
Bilingual (Spanish) preferred but not required
DM ClinicalResearch, the largest privately-owned clinicalresearch organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded ClinicalResearch Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinicalresearch trials.
Duties & Responsibilities:
Compound and dispense prescribed IP.
Supervise and maintain records of all medications
Ensure compliance with study-specific blinding plans.
Provide consultative support regarding the preparation and dosing of drugs.
Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction.
Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials.
Understand and apply all applicable site procedures.
Ensure receipt and proper storage of IP and bioretention samples.
Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy.
Review protocols and provide input on clinical and pharmacy supply needs.
Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information.
Temperature reporting.
Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Foreign Medical Graduate is a plus
Pharmacy Technician Certification a plus
Experience:
Clinical Experience
Credentials:
LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant)
Knowledge and Skills:
Computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Excellent communication and customer service skills.
Outgoing personality Well-organized with attention to detail.
Must be able to multitask.
Bilingual (Spanish) preferred but not required
$52k-76k yearly est. 60d+ ago
Clinical Research Scientist (EZIJP00002334)
Artech Information System 4.8
Clinical research associate job in Woodcliff Lake, NJ
Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.
Job 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, Client, 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
BS/MS
Additional Information
For more information, Please contact
Best Regards,
Akriti Gupta
**************
Morristown, NJ 07960
$79k-116k yearly est. 60d+ ago
Clinical Research Scientist
Integrated Resources 4.5
Clinical research associate job in Woodcliff Lake, NJ
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
Title: ClinicalResearch Scientist
Duration: 12 Months (Possibility of Extension)
Location Woodcliff lake NJ
Job Responsibilities:
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
Qualifications
Qualifications
Minimum of 2-5 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) or MD degree preferred.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus
Thank you for your time and consideration. I look forward to hearing from you!
Kind Regards
Ruchi Kumari
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(DIRECT BOARD) # 732-844-8716 (F) 732-549-5549
LinkedIn: https://www.linkedin.com/in/ruchi-kumari
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$77k-115k yearly est. 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
Clinical Research Scientist
Mitsubishi Tanabe Pharma America 4.1
Clinical research associate job in Jersey City, NJ
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Reporting to the Senior Director, Clinical Development, the ClinicalResearch Scientist will provide
leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinicalresearch and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion.
The ClinicalResearch Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinicalresearch in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible.
Job Description
Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
submissions such as INDs.
Author abstracts and manuscripts for publication in peer-reviewed journals.
Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
Ability to prepare, present and defend complex aspects of protocol design and/or study data at
investigator and internal meetings.
Oversee and coordinate the collection of and/or collect pre-study documents
Participate in data review and discrepancy resolution, team meetings/presentations with increasing
levels of independence and support the Program Clinical Leader or Sr. Management as needed.
Assist in managing regulatory safety reporting with the following: SAE queries and follow-up,
annual reports, investigator brochures, ability to learn various databases.
Critically review and synthesize complex information from reviews of the scientific and clinical
literature.
Qualifications
Minimum 2-5 years of pharmaceutical industry clinical trial experience.
Experience in immunology or endocrinology therapeutic areas is a plus.
Primary experience with development of clinical trial protocols.
Medical or scientific writing experience a must and familiarity with clinically applied science or
pharmaceutical development.
Good understanding of FDA regulatory, ICH, and GCP requirements.
Excellent communication skills, written and verbal.
Superior interpersonal communication and the ability to work across company disciplines and functional units.
Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and a commitment to high quality and on-time deliverables are key success factors.
Willingness to travel up to 30% domestically and internationally.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
$75k-125k yearly est. 60d+ ago
Oncology CRA/Clinical Site Monitor (field-based) - NY/NJ
Astellas Pharma, Inc. 4.9
Clinical research associate job in Jersey City, NJ
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This field-based position is based in either New York or New Jersey.
Purpose and Scope:
A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
Responsibilities may include assisting with or primary responsibility for:
* Site Selection
* Pre-trial assessment
* Site level Study Participant recruitment/retention plans
* Site Activation/Initiation
* On-site and remote monitoring
* Overall site relationship management in collaboration with other sponsor roles that interact with the site
* Close-out activities
Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
Responsibilities & Accountabilities:
* Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
* Develops meaningful site relationships through consistent collaborative communication and engagement.
* May participate in site feasibility and/or pre-trial site assessment visits.
* Attends/participates in investigator meetings as needed.
* May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
* Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
* Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
* Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
* Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
* Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
* Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
* Ensures site non-IMP study supplies are adequate for trial conduct.
* Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
* Oversees the appropriate destruction of clinical supplies.
* Ensures site staff complete data entry and resolve queries within expected timelines.
* Ensures validity and completeness of data collected at trial sites.
* Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
* Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
* Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
* Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
* Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
* Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
* Prepares trial sites for close out, conduct final close out visit.
* Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
* May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
* May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.
$67k-110k yearly est. 14d ago
Clinical Study Coordinator/Specialist
Henkel 4.7
Clinical research associate job in Stamford, CT
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 account here 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
About Henkel
Building on a strong legacy of almost 150 years, we are leading the way to reimagine and improve life every day. Today and for generations to come. Through our innovative and sustainable brands and technologies, across our teams around the world.
Henkel holds leading positions in both industrial and consumer businesses: Our portfolio includes well-known hair care products, laundry detergents, fabric softeners as well as adhesives, sealants, and functional coatings.
$70k-80k yearly Easy Apply 26d ago
Clinical Research Coordinator I (Yonkers, NY)
Care Access 4.3
Clinical research associate job in Yonkers, NY
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like
Future of Medicine
, which makes advanced health screenings and research opportunities accessible to communities worldwide, and
Difference Makers
, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinicalresearch and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit *******************
How This Role Makes a Difference
The ClinicalResearch Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinicalresearch study subjects while ensuring protocol and regulatory compliance.
How You'll Make An Impact
Patient Coordination
Prescreen study candidates
Obtain informed consent per Care Access Research SOP.
Complete visit procedures in accordance with protocol.
Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.
Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.
Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.
Prioritize activities with specific regard to protocol timelines
Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.
Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.
Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)
Documentation
Record data legibly and enter in real time on paper or e-source documents
Accurately record study medication inventory, medication dispensation, and patient compliance.
Resolve data management queries and correct source data within sponsor provided timelines.
Assist regulatory personnel with completion and filing of regulatory documents.
Assist in the creation and review of source documents.
Patient Recruitment
Assist with planning and creation of appropriate recruitment materials.
Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.
Actively work with recruitment team in calling and recruiting subjects
Other Responsibilities
Review and assess protocol (including amendments) for clarity, logistical feasibility
Ensure that all training and study requirements are met prior to trial conduct.
Communicate clearly verbally and in writing.
Attend Investigator meetings as required.
Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)
Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management
Maintain effective relationships with study participants and other care Access Research personnel.
The Expertise Required
Ability to understand and follow institutional SOPs.
Excellent working knowledge of medical and research terminology
Excellent working knowledge of federal regulations, good clinical practices (GCP)
Ability to communicate and work effectively with a diverse team of professionals.
Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail
Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.
Critical thinker and problem solver
Friendly, outgoing personality; maintain a positive attitude under pressure.
High level of self-motivation and energy
Excellent professional writing and communication skills
Ability to work independently in a fast-paced environment with minimal supervision.
Certifications/Licenses, Education, and Experience:
Bachelor's Degree preferred, or equivalent combination of education, training and experience.
A minimum of 1-year prior ClinicalResearch Coordinator experience required
Recent phlebotomy experience required
How We Work Together
Location: Position requires onsite work 5 days per week at the Yonkers, NY or Hoboken, NJ clinic.
Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives.
Physical demands associated with this position Include:
Walking-20%
Standing-20%
Sitting-20%
Lifting-20%
Up to 25lbs Overhead
Driving-20%
The expected salary range for this role is $55,000 - $85,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
Paid Time Off (PTO) and Company Paid Holidays
100% Employer paid medical, dental, and vision insurance plan options
Health Savings Account and Flexible Spending Accounts
Bi-weekly HSA employer contribution
Company paid Short-Term Disability and Long-Term Disability
401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
$55k-85k yearly Auto-Apply 5d ago
Clinic Research Coordinator II
DM Clinical Research
Clinical research associate job in Jersey City, NJ
ClinicResearch Coordinator II The ClinicalResearch Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis.
Duties & Responsibilities:
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis.
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to:
a. Sponsor-provided and IRB-approved Protocol Training
b. All relevant Protocol Amendments Training
c. Any study-specific Manuals Training, as applicable
d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols.
Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols.
Submitting required administrative paperwork per company timelines.
Participating in subject recruitment and retention efforts.
Engaging with Research Participants and understanding their concerns.
Any other matters, as assigned by management.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Bachelor's degree a plus
Foreign Medical Graduates preferred
Experience:
At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinicalresearch setting
Credentials:
ACRP or equivalent certification is preferred
Registered Medical Assistant certification or equivalent is preferred
Knowledge and Skills:
Be an energetic, go-getter who is detail-oriented and can multi-task.
Be goals-driven while continuously maintaining quality.
Bilingual in Spanish is preferred
How much does a clinical research associate earn in Greenburgh, NY?
The average clinical research associate in Greenburgh, 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 Greenburgh, NY
$67,000
What are the biggest employers of Clinical Research Associates in Greenburgh, NY?
The biggest employers of Clinical Research Associates in Greenburgh, NY are: