Clinical research coordinator jobs in Greenwich, CT - 148 jobs
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Senior Research Coordinator
Senior Clinical Research Coordinator
Northwell Health 4.5
Clinical research coordinator job in New Hyde Park, NY
Exhibits technical and functional expertise in the area of research through the development of protocols, hypotheses and educational curricula. Coordinates daily activities of a designated study or group of studies and maintains industry relationships. Guides training of faculty physicians, residents, medical students and research staff on good clinical practice, external regulatory agency requirements.
Job Responsibility
+ Develops scientific protocols and generates hypotheses for research inquiries independently and in collaboration with faculty and trainees; provides technical and functional expertise in the area of research studies.
+ Creates and implements research education core curriculum for residents and faculty in conjunction with physician leadership; coordinates visiting professors for research topics; prepares lectures and presentations on research topics.
+ Drafts research policies with departmental leadership - participates on departmental research board to vet proposed projects for feasibility, ethics and academic rigor; prepares manuscripts for publication in peer-reviewed journals and scientific meetings.
+ Uses statistical software to analyze study data and interface with biostatisticians for analysis; engages physician leaders from various specialties to develop collaborative multidisciplinary research.
+ Oversees the administration of assessments as assigned and as related to study protocol.
+ Collects data, confers with PI and forwards results to sponsor (internal or external).
+ Interfaces with external agencies; organizes all phases of grant process for submission to funding agencies as necessary.
+ Oversees clinicalresearch staff performing clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educates family and contributes to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria.
+ Liaises with agencies, pharmaceutical companies, laboratories, and equipment and supply companies as needed; oversees availability of supplies and/or equipment for studies.
+ Identifies and pursues extramural funding opportunities through pursuit of grants and clinical trials; collaborates with physicians, investigators and other healthcare providers regarding subject care as necessary.
+ Operates under limited guidance and work assignments involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
+ Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.
Job Qualification
+ Bachelor's Degree required, or equivalent combination of education and related experience.
+ 3-5 years of relevant experience, required.
+ Clinical trial experience, preferred
+ Experience with grants, preferred
*Additional Salary Detail
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).
The salary range for this position is $62250-$100130/year
It is Northwell Health's policy to provide equal employment opportunity and treat all applicants and employees equally regardless of their age, race, creed/religion, color, national origin, immigration status or citizenship status, sexual orientation, military or veteran status, sex/gender, gender identity, gender expression, disability, pregnancy, genetic information or genetic predisposition or carrier status, marital or familial status, partnership status, victim of domestic violence, sexual or other reproductive health decisions, or other characteristics protected by applicable law.
$62.3k-100.1k yearly 6d ago
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Clinical Research Associate
Artech Information System 4.8
Clinical research coordinator 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. 1d ago
Clinical Research Scientist
Integrated Resources 4.5
Clinical research coordinator 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 Study Coordinator/Specialist
Henkel 4.7
Clinical research coordinator 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 coordinateclinical 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), ClinicalCoordinator 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 ClinicalCoordinator 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 Associate
Touro University 4.4
Clinical research coordinator 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
Manager, Clinical Research
NS Pharma Inc.
Clinical research coordinator 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 7d ago
Cancer Clinical Trials Data Coordinator
Stony Brook University 4.1
Clinical research coordinator job in Stony Brook, NY
Required Qualifications (as evidenced by an attached resume): Associate's degree (foreign equivalent or higher). In lieu of an Associate's degree, a high school diploma (foreign equivalent or higher) and two (2) years of full-time experience in a clinical setting may be considered. One (1) year of full-time experience in a clinical setting with basic fundamental knowledge of medical and scientific terminology. Proficiency in Microsoft Word and Excel. Experience working with an EMR.
Preferred Qualifications:
Experience with Data collection and management. Experience with clinical trials and the IRB regulatory process. Previous work history relating to Oncology. IRB training. Advanced proficiency in Microsoft Excel. Experience maintaining databases.
Brief Description of Duties:
At Stony Brook Medicine, a Data Coordinator is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior communication and organization skills while adhering to our high standard of excellence. Extreme attention to detail. Excellent organizational and communication skills (both verbal and written). Duties of a Data Coordinator in our Cancer Clinical Trials department may include but are not limited to the following:
* Performs the timely and accurate data entry and monitoring of databases for collection of Clinical Trial Data.
* Chart Review/Data Collection of patient medical records and creation of clinical record charts. Completion of data case report forms both paper and electronic.
* Participates in the initiation of studies with pharmaceutical companies and cooperative groups.
* Assists with reporting all adverse drug reactions to the Federal Drug Administration (FDA), National Cancer Institute (NCI), Oncology Cooperative Groups, IRB and sponsoring drug companies.
* Ensures appropriate patient follow-up as required by protocol.
* Assist with the submission of protocols, amendments, notices and terminations to the Institutional Review Board (IRB), regulatory agencies and sponsors for review and approval.
* Other duties as assigned.
Special Notes:
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Non-Exempt position, eligible for the overtime provisions of the FLSA.
For this position, we are unable to sponsor candidates for work visas.
Resume/CV and cover letter should be included with the online application.
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ************** or visit OEA.
In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.
Visit our WHY WORK HERE page to learn about the total rewards we offer.
SUNY Research Foundation: A Great Place to Work.
The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.
'728618
$52k-68k yearly est. 6d ago
Clinical Research Scientist
Lancesoft 4.5
Clinical research coordinator 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 Associate
Nymc
Clinical research coordinator 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 Trials Manager
Global Channel Management
Clinical research coordinator job in Fort Lee, NJ
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
Clinical Trial Manager needs Bachelor's degree and minimum 3 years
experience in the healthcare or clinical trial industry, or the
equivalent combination of education and experience.
Clinical Trial Manager requires:
Extensive
knowledge of clinical development principles, theories and concepts and
high degree of comprehension of pharmaceutical industry practices,
standards and GCP's.
Thorough working knowledge of the clinical
trial lifecycle from protocol development and feasibility through study
closeout and reporting.
Ability to manage complex, multiple studies simultaneously. Some may be of a global nature
Clinical Trial Manager duties:
Manages/oversees
the conduct and execution of assigned clinical trails and associated
activities in accordance with Good Clinical Practices (GCP) and relevant
standards.
Assists with the review and determination of
appropriate site and vendor selection and ensures all vendors meet
predetermined program milestones.
Additional Information
$54/hr
12 months
$54 hourly 1d ago
Research Coordinator
White Plains Hospital Center 4.6
Clinical research coordinator job in White Plains, NY
Reporting dually to the Sr. Administrative Director of Neurosciences and the Director of Research, the ClinicalResearchCoordinator duties will include activities such as data collection and management of patient clinical information, timely collection of protocol related samples including shipment to outside entities as required, assist in obtaining informed consent, collect, maintain and organize study information, and assist with other day-to-day operations as required. Research projects may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies. The individual who holds this position acts in accordance with all local, state, federal and IRB policies and procedures.
Essential Functions and Responsibilities Includes the Following:
* Coordinates activities of ongoing clinical trials
* Assists in the activities related to clinicalresearch studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires, coordinating participants' study visits and procedures.
* Assists in obtaining informed consent under supervision of the study investigator(s); educate participants regarding study requirements.
* Screen patients for eligibility and register subjects with sponsoring agency.
* Coordinateresearch team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
* Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol.
* Act as liaison between investigator(s) and sponsoring agency.
* Coordinate activities pertinent to the safeguarding of patients' rights in research.
* Manage study data of ongoing clinical trials under supervision of the PI(s):
* Ensure accurate and complete compilation of subject data through chart reviews.
* Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines.
* Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol.
* Maintain source documents and subject files in accordance with White Plains Hospital's (WPH) Standard Operating Procedures (SOPs).
* Assist with analyzing data as needed.
* Performs other job-related duties as required, may include but not limited to:
* Reports adverse events and serious adverse events in accordance with WPH Institutional Review Board (IRB)/CIRB/BRANY SOPs, sponsor guidelines, and federal regulations.
* Assist the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
* Participate in Investigators' Meeting and assist with coordinating Study Initiation Visits.
* Attend divisional/departmental/institutional educational and training seminars.
* Contact local physicians to obtain source documentation and subject survival status.
* Educate new staff regarding overview of clinicalresearch, office policy and procedures, data submission, patient registration and specimen handling.
* Understands and adheres to the WPH Performance Standards, Policies and Behaviors.
* Performs all other related duties as assigned.
Education & Experience Requirements
Experience:
* Minimum of one (1) year of experience in the field of data entry or clinicalresearch required.
* Experience submitting IRB applications (new and amendments) preferred.
* Knowledge of clinical trial federal, state and local regulations preferred.
* Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked Changes
* functionality required.
* Excellent interpersonal and communication skills required.
* Understands and adheres to the WPH Performance Standards, Policies and Behaviors
Education:
* Bachelor's degree required, in relevant field preferred.
* Research certification (e.g. RAPS, ACRP, SoCRA or equivalent) preferred.
Core Competencies
* Coordinatesclinical trial activities accordance to the protocol such as screening, subject registration, schedule of
* study visits, etc.
* Prepares, processes, handles, and ships biospecimen samples to the appropriate lab as outlined by the
* sponsors, lab manual, or protocol.
* Maintains and enters data for ongoing clinical trials
* Assists regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
Clinical Trial Management
* Track and manage assigned protocols and subject enrollments
* Coordinate study visits with internal staff, vendors, and the sponsor.
* Create and maintain tracking for all safety reporting, all required deviations/violations, etc.
Stakeholder Engagement
* Establish and maintain regular communication with study team including the PI's, study sponsor, and applicable
* regulatory agencies to ensure all required information is communicated.
* Serve as liaison for study team, clinical team and sponsor with regard to study status information, safety issues,
* upcoming protocol amendments and consent changes and applicable protocol training.
Leadership and Professionalism
* Maintain working knowledge of current regulations, regulatory guidance and or local policies.
* Assists ClinicalResearch Director with regulatory based training and implementation of new or revised regulation,
* guidance and or local policy.
* Present study and subject status updates at applicable research meetings.
* Protocol oversight; monitoring and reporting of study events; data collection; adherence to study protocols; inservice
* education of physicians, nurses, and support staff to protocol requirements; coordinateresearch activities.
Physical/Mental Demands/Requirements & Work Environment
* May be exposed to chemicals necessary to perform required tasks. Any hazardous chemicals the employee may be exposed to are listed in the hospital's SDS (Safety Data Sheet) data base and may be accessed through the hospital's Intranet site (Employee Tools/SDS Access). A copy of the SDS data base can also be found at the hospital switchboard, saved on a disc.
Primary Population Served
Check appropriate box(s) below:
â˜Neonatal (birth - 28 days)
â˜Patients with exceptional communication needs
â˜Infant (29 days - less than 1 year)
â˜Patients with developmental delays
â˜Pediatric (1 - 12 years)
â˜Patients at end of life
â˜Adolescent (13 - 17 years)
â˜Patients under isolation precautions
â˜Adult (18 - 64 years)
â˜Patients with cultural needs
â˜Geriatric (> 65 years)
â˜'All populations
â˜Bariatric Patients with weight related comorbidities
☠Non-patient care population
The responsibilities and tasks outlined in this job description are not exhaustive and may change as determined by the needs of White Plains Hospital.
[LZ1]List core competencies required to carry out the primary responsibilities of the job to be successful
Examples:
Teamwork Adaptability
Communication skills Problem-solving skills
Planning and organizing Attention to detail
Problem-solving skills Judgment and decision-making
Stress tolerance Project management
$49k-67k yearly est. 14d ago
Clinical Research Coordinator I (Yonkers, NY)
Care Access 4.3
Clinical research coordinator 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 ClinicalResearchCoordinator'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 ClinicalResearchCoordinator 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
Clinical Trials Coordinator - Unlicensed
The Stamford Hospital 4.8
Clinical research coordinator 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.
Coordinateresearch 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.
$42k-58k yearly est. Auto-Apply 57d ago
Clinical Trials Coordinator - Unlicensed
Stamford Health 4.8
Clinical research coordinator 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.
Coordinateresearch 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 57d ago
Senior Clinical Research Associate (Midwest - Illinois/Michigan)
Icon Clinical Research
Clinical research coordinator job in Ridgefield, NJ
Sr. ClinicalResearch Associate NY/NJ ICON plc is a world-leading healthcare intelligence and clinicalresearch organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Senior ClinicalResearch Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine.
+ Extensive experience as a ClinicalResearch Associate, with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
+ Must be located in the Midwest (areas like Chicago or Detroit/Ann Arbor, MI are ideal)
+ Oncology monitoring experience required
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site (************************************* to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (******************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here (****************************************************** to apply
$73k-116k yearly est. 60d+ ago
Clinical Study Manager
Daiichi Sankyo 4.8
Clinical research coordinator job in Ridgefield, NJ
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Job Summary
The Clinical Study Manager is responsible for the delivery and execution of global clinical studies under the direction of a Study Delivery Lead. This role is primarily focused on tactical study delivery and reports to a Director or higher-level position. The position requires excellent written and verbal communication, project management skills, and attention to detail. The Clinical Study Manager will have routine interaction with key internal and external stakeholders to communicate project status, resolve issues, and troubleshoot routine inquiries. This position may require the Clinical Study Manager to take on a dual role of both operational strategy and study execution.
Job Description
Responsibilities
Clinical Operations Study Management(Global) has primary accountability for operational execution and delivery of assigned clinical trials, including study level time, cost and quality deliverables. In a CRO outsourcing model, responsibilities also include:
* Study Oversight: Lead the clinical study operational aspects of planning, execution, and management of one or more Phase 1-3 clinical trials. May provide support as back-up to the Study Delivery Lead as needed.
* Cross-Functional Leadership: Participate and provide expertise as a cross-functional study team member, including vendors, and liaise with other departments. Provide mentorship of more junior Operations team members.
* Vendor Management: Lead vendor selection, contracting, and management to maintain study quality and compliance and adherence to scope of work within timelines and budget. Oversee complex vendors (i.e., eCOA).
* CRO Oversight: Responsible for the oversight, performance, and management of CRO(s) and 3rd party vendors (sub-contracted by CRO) to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Coordinate and develop materials for CRO KOMs and Investigator meetings.
* Compliance and Regulatory: Ensure compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).
* Timeline and Budget Management: Create and coordinateclinical study timelines and budgets with Global Project Management and R&D Finance to meet critical milestones and manage budgets. Responsible for continual review of study timelines and study budget.
* Risk Management: Identify, mitigate, and escalate risks per process throughout the study lifecycle. Ensure risks are appropriately logged in the risk management system.
* Study Material Development: Co-develop and manage study materials, including training materials, protocols, CRFs, and study operational plans. Ensure all necessary operational materials are in place.
* Data Cleaning: Oversee site and monitor data cleaning metrics including EDC data entry, query resolution timeliness, and protocol deviation review.
* Site Management: Oversee site selection, start-up, monitoring, and closeout for the trial.
* Study Communication: Triage, resolve or escalate study issues /risk mitigations to the Study Delivery Lead.
* Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).).
oSupports risk Management initiatives
oSupports audit/inspection activities as needed
oEnsures trial master file is complete and accurate for assigned stud(ies)
* Communication and Reporting: Provide regular updates on study progress to key stakeholders.
* Training: Identify training needs for key stakeholders as needed, e.g., study team members, vendors and ensure training is carried out. Develop training materials as necessary.
Responsibilities Continued
Qualifications
Education Qualifications
Bachelor's Degree preferred in Life Sciences required
Experience Qualifications
3 or more years required and
Relevant experience is required with a BSc required and
Experience in oversight of global clinical trials (all phases) in all stages of delivery with requisite industry training and experience required and
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
CRA experience preferred
Time spent directly in a medical environment (e.g. as a Study Site Coordinator) preferred
Familiarity to a Japan-based organization preferred
Travel Requirements
Ability to travel up to 10% of the time. In-house office position that may require occasional travel (domestic or global).
Additional Information
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$133,600.00 - USD$200,400.00
Download Our Benefits Summary PDF
$57k-95k yearly est. 5d ago
Cancer Clinical Trials Data Coordinator
Sbhu
Clinical research coordinator job in Stony Brook, NY
Cancer Clinical Trials Data Coordinator Required Qualifications (as evidenced by an attached resume): Associate's degree (foreign equivalent or higher). In lieu of an Associate's degree, a high school diploma (foreign equivalent or higher) and two (2) years of full-time experience in a clinical setting may be considered.
One (1) year of full-time experience in a clinical setting with basic fundamental knowledge of medical and scientific terminology.
Proficiency in Microsoft Word and Excel.
Experience working with an EMR.
Preferred Qualifications: Experience with Data collection and management.
Experience with clinical trials and the IRB regulatory process.
Previous work history relating to Oncology.
IRB training.
Advanced proficiency in Microsoft Excel.
Experience maintaining databases.
Brief Description of Duties: At Stony Brook Medicine, a Data Coordinator is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital.
Qualified candidates will demonstrate superior communication and organization skills while adhering to our high standard of excellence.
Extreme attention to detail.
Excellent organizational and communication skills (both verbal and written).
Duties of a Data Coordinator in our Cancer Clinical Trials department may include but are not limited to the following:Performs the timely and accurate data entry and monitoring of databases for collection of Clinical Trial Data.
Chart Review/Data Collection of patient medical records and creation of clinical record charts.
Completion of data case report forms both paper and electronic.
Participates in the initiation of studies with pharmaceutical companies and cooperative groups.
Assists with reporting all adverse drug reactions to the Federal Drug Administration (FDA), National Cancer Institute (NCI), Oncology Cooperative Groups, IRB and sponsoring drug companies.
Ensures appropriate patient follow-up as required by protocol.
Assist with the submission of protocols, amendments, notices and terminations to the Institutional Review Board (IRB), regulatory agencies and sponsors for review and approval.
Other duties as assigned.
Special Notes:The Research Foundation of SUNY is a private educational corporation.
Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding.
FLSA Non-Exempt position, eligible for the overtime provisions of the FLSA.
For this position, we are unable to sponsor candidates for work visas.
Resume/CV and cover letter should be included with the online application.
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ************** or visit OEA.
In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.
Visit our WHY WORK HERE page to learn about the total rewards we offer.
SUNY Research Foundation: A Great Place to Work.
The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Job Number: 2600030Official Job Title: ClinicalResearch AssistantJob Field: Administrative & Professional (non-Clinical) Primary Location: US-NY-Stony BrookDepartment/Hiring Area: Cancer CenterSchedule: Full-time Shift :Day Shift Shift Hours: 9:00am-5:00pm Posting Start Date: Jan 20, 2026Posting End Date: Feb 4, 2026, 4:59:00 AMSalary:$50,000-$60,000Appointment Type: RegularSalary Grade:N8 SBU Area:The Research Foundation for The State University of New York at Stony Brook
$50k-60k yearly Auto-Apply 1d ago
Cancer Clinical Trials Data Coordinator
Stonybrooku
Clinical research coordinator job in Stony Brook, NY
Cancer Clinical Trials Data Coordinator Required Qualifications (as evidenced by an attached resume): Associate's degree (foreign equivalent or higher). In lieu of an Associate's degree, a high school diploma (foreign equivalent or higher) and two (2) years of full-time experience in a clinical setting may be considered.
One (1) year of full-time experience in a clinical setting with basic fundamental knowledge of medical and scientific terminology.
Proficiency in Microsoft Word and Excel.
Experience working with an EMR.
Preferred Qualifications: Experience with Data collection and management.
Experience with clinical trials and the IRB regulatory process.
Previous work history relating to Oncology.
IRB training.
Advanced proficiency in Microsoft Excel.
Experience maintaining databases.
Brief Description of Duties: At Stony Brook Medicine, a Data Coordinator is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital.
Qualified candidates will demonstrate superior communication and organization skills while adhering to our high standard of excellence.
Extreme attention to detail.
Excellent organizational and communication skills (both verbal and written).
Duties of a Data Coordinator in our Cancer Clinical Trials department may include but are not limited to the following:Performs the timely and accurate data entry and monitoring of databases for collection of Clinical Trial Data.
Chart Review/Data Collection of patient medical records and creation of clinical record charts.
Completion of data case report forms both paper and electronic.
Participates in the initiation of studies with pharmaceutical companies and cooperative groups.
Assists with reporting all adverse drug reactions to the Federal Drug Administration (FDA), National Cancer Institute (NCI), Oncology Cooperative Groups, IRB and sponsoring drug companies.
Ensures appropriate patient follow-up as required by protocol.
Assist with the submission of protocols, amendments, notices and terminations to the Institutional Review Board (IRB), regulatory agencies and sponsors for review and approval.
Other duties as assigned.
Special Notes:The Research Foundation of SUNY is a private educational corporation.
Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding.
FLSA Non-Exempt position, eligible for the overtime provisions of the FLSA.
For this position, we are unable to sponsor candidates for work visas.
Resume/CV and cover letter should be included with the online application.
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ************** or visit OEA.
In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.
Visit our WHY WORK HERE page to learn about the total rewards we offer.
SUNY Research Foundation: A Great Place to Work.
The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Job Number: 2600030Official Job Title: ClinicalResearch AssistantJob Field: Administrative & Professional (non-Clinical) Primary Location: US-NY-Stony BrookDepartment/Hiring Area: Cancer CenterSchedule: Full-time Shift :Day Shift Shift Hours: 9:00am-5:00pm Posting Start Date: Jan 20, 2026Posting End Date: Feb 4, 2026, 4:59:00 AMSalary:$50,000-$60,000Appointment Type: RegularSalary Grade:N8 SBU Area:The Research Foundation for The State University of New York at Stony Brook
$50k-60k yearly Auto-Apply 2h ago
Senior Fundamental Alpha Researcher (USA)
Trexquant Investment 4.0
Clinical research coordinator job in Stamford, CT
Job Description
Trexquant is a systematic hedge fund where we use thousands of statistical algorithms to trade equity, futures and other markets globally. Starting with many data sets, we develop large sets of features and use various machine learning methods to discover trading signals and effectively combine them into market-neutral portfolios. Our Senior Fundamental Alpha Research team is a small collaborative team working to create new alphas.
You will focus on identifying and developing systematic, market-neutral trading signals based on your understanding of fundamental data, accounting, and financial analysis. You will collaborate with the Data and Strategy team to build a diverse set of predictive models.
Key Responsibilities
Leveraging fundamental data to formulate predictive, market-neutral signals
Designing, implementing, and optimizing various machine learning models to parse data sets for fundamental alpha development
Collaborating with experienced and resourceful quantitative researchers to carry out experiments and test hypothesis using simulations
Optimizing models using domain-specific data to enhance relevance and interpretability in a financial context
Working with large-scale structured and unstructured data sets to develop robust feature pipelines for downstream use in alpha research
Requirements
BS/MS/PhD in any STEM field, finance, accounting, or related discipline
Interest in applying fundamental analysis in a systematic, model-driven context
Knowledge of financial accounting and company fundamentals (CFA or CPA a plus)
Background in quantitative finance is a plus, but not necessary
Benefits
Competitive salary plus bonus based on individual and company performance
Collaborative, Casual, and friendly work environment
PPO Health, dental and vision insurance premiums fully covered for you and your dependents
Pre-tax commuter benefits
Weekly company meals
Trexquant is an Equal Opportunity Employer.
$56k-91k yearly est. 9d ago
Study Coordinator
Albert Einstein College of Medicine 4.5
Clinical research coordinator job in Bronxville, NY
About Us
The Cognitive Neurophysiology Laboratory is comprised of a multidisciplinary team of investigators, post-doctoral fellows, and students using psychophysics, EEG, and MRI to study attention, auditory and visual perception, multisensory processing, and executive function, in typical and clinical populations. It is our goal to make significant advances in understanding these processes with the use of cutting edge methodologies and data analytic techniques. In turn, we seek to apply this understanding to explore the processing deficits underlying clinical and developmental disorders such as autism, schizophrenia, and drug addiction.
POSITION RESPONSIBILITIES
We are seeking a Study Coordinator to assist in the lab's various studies on a daily basis, to ensure that each project is completed in accordance with the appropriate protocol. Responsibilities include overseeing participant scheduling and recruitment; proper collection of EEG, MRI, genetic, and neuropsychological data; archiving data and maintaining the CNL database of more than 1800 participant records; and providing assistance in the preparation of data for presentations, publications, and other purposes. Opportunities to contribute to our research in a meaningful way will be abundant.
Oversees the recruitment, screening, scheduling, enrollment, interaction with, and consenting of subjects.
Monitors projects (including scheduling and interacting with participants) and provides updates.
Prepares and submits materials for the Institutional Review Board (IRB) and other regulatory bodies as
required by the protocol to ensure compliance in a timely fashion.
Assists with regulatory matters (such as data safety and monitoring and board meetings).
Organizes and maintains documentation of participant and study data.
Manages data collection and databases.
May provide clerical and technical guidance to ensure adherence to research protocols and quality of
information received.
Assists faculty by recording during data collection, data review and data entry, as appropriate for study
Interacts with co-workers, visitors, and other staff consistent with the values of Einstein
QUALIFICATIONS
BA or BS in a related field
1-2 years of related experience preferred.
Database management experience desirable
Prior experience with human subject research protocols (especially involving EEG) preferred
Additional Information In compliance with NYC's Pay Transparency Act, the hourly rates for this are listed below. This rate is based on the 1199 bargaining unit contract. Minimum Salary Range USD $58,500.00/Yr. Maximum Salary Range USD $58,500.00/Yr.
$58.5k yearly Auto-Apply 35d ago
Learn more about clinical research coordinator jobs
How much does a clinical research coordinator earn in Greenwich, CT?
The average clinical research coordinator in Greenwich, CT earns between $44,000 and $93,000 annually. This compares to the national average clinical research coordinator range of $37,000 to $72,000.
Average clinical research coordinator salary in Greenwich, CT
$64,000
What are the biggest employers of Clinical Research Coordinators in Greenwich, CT?
The biggest employers of Clinical Research Coordinators in Greenwich, CT are: