Clinical Scientist Data Reviewer
Clinical research coordinator job in Jersey City, NJ
6 month contract w/ renewal
3 days onsite in Jersey City, NJ
We are seeking a Clinical Scientist Data Reviewer that will support the scientific planning efforts and collaborate with Clinical Research, Pharmacovigilance and Clinical Operations in the execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate technical skills and scientific acumen as part of a cross-functional clinical development team. You will be a key contributor and supporter in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians, including protocol development, study implementation, data analysis and reporting of results. This role will be focused on the detailed and critical safety data review efforts from study start-up through final CSR. The Clinical Scientist Data Reviewer is a crucial role in analyzing and interpreting clinical trial data to ensure accuracy, integrity, and compliance with regulatory requirements. There is additional room for growth and leadership opportunities in this role.
Responsible for supporting specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
Serving as a supportive clinical scientist data reviewer focused on safety, efficacy and critical data deliveries as part of the clinical trial team
Supporting the clinical study team as part of the clinical sciences functional line which is closely aligned with the medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with Clinical Research and Pharmacovigilance (as well as other functional areas in this matrix environment)
Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); partnering with Clinical Operations on critical and key study deliverables
Ensure CRF design supports data collection in alignment with the Protocol in collaboration with Clinical Data Management/Programming
Collaborating cross-functionally to review clinical data to ensure quality, completeness, and integrity of trial conduct
Potential to provide tactical/scientific mentorship to other clinical scientists and move into Clinical Scientist lead role as well as focus on scientific growth and development
Responsible for assisting with the generation, analysis, and presentation of clinical data, including manuscripts, abstracts, and oral presentations (including authoring documents and slide preparation as appropriate)
Apply proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; identifies risks and designs mitigation strategies
Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs
Qualifications
6+ years of experience with a Post Graduate Degree or 8+ years of experience with a Bachelor's degree in a relevant scientific discipline.
Experience in clinical drug development experience, or a PhD, Pharm D, or RN degree is preferred.
Experience within oncology preferred
Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
Ability to manage multiple competing priorities with good planning, time management and prioritization skills
Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports
Interact with key stakeholders across Clinical Development functional areas
Role requires proactive approach, strategic thinking and leadership in driving toward clinical study goals
Influence opinions and decisions of internal and external customers / vendors, across functional areas
Problem solving, prioritization, conflict resolution and critical thinking skills
Strong communication, technical writing, and presentation skills experience
Clinical Research Associate
Clinical research coordinator job in New York, NY
**This role will be hybrid in NYC**
Required Experience:
· Bachelor's degree, preferably in science, public health, health education, or a related field
· Prior experience in healthcare or research settings
· Prior patient education experience
· Knowledge of research methodologies, protocols, and regulatory requirements
· Attention to detail and a commitment to maintaining accurate and confidential patient records
· Proficiency in using electronic health records (EHR) systems and other relevant software applications (eg, REDCap, Qualtrics), including qualitative research tools (eg, Dedoose, Atlas.ti)
· Compassionate and patient-centered approach to care, with a commitment to ensuring patient safety and well-being
Job Responsibilities:
· Assist coordinators with daily participant-related tasks.
· Recruit and screen potential patients/subjects for study eligibility.
· Schedule and confirm participant visits.
· Maintain regular contact with patients; send visit reminders and encourage compliance with research protocols.
· Interact with patients, subjects, and their families in a courteous, professional, and cooperative manner.
· Ensure all communication with participants is effective and respectful.
· Collaborate with various personnel involved in different aspects of the study.
· Ensure all protocol compliance, including adherence to eligibility criteria, follow-up procedures, and documentation standards.
· Assist with regulatory procedures required by the NYU Institutional Review Board (IRB) and external IRBs to maintain approvals for human subjects research.
· Utilize established quantitative and qualitative methodologies to collect research data from patients, partners, staff, and/or trainees.
· Gather, compile, and input clinical and nonclinical data into databases or case report forms.
· Maintain a thorough understanding of research studies and associated procedures.
· Ensure compliance with study protocols and address any issues that arise.
Clinical Research Manager
Clinical research coordinator job in Belleville, NJ
Regional Cancer Care Associates (RCCA) is looking for an exceptional Clinical Research Manager to join the team. This position manages clinical research program and operations in accordance with USON SOP and ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives.
ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures(SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include Code of Ethics and Business Standards.
This individual must also possess strong multi-tasking abilities and bring positivity and passion to their work. If you want to join a team that is on the cutting edge of cancer care, while always putting the patient first, we want to hear from you!
Employment Type: Full Time
Location: Belleville, NJ
As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being and professional growth of our employees.
Key Responsibilities:
Manages clinical research program and operations in accordance with USOR SOP and ICH GCP guidelines. Responsible for
ensuring at the administrative level that all research activities are coordinated with affected departments within the practice.
Coaches and develops staff. Responsible for recruitment, interviewing, recommending hires, assessing performance,
recommending salary changes, and progressive discipline. Enforces adherence to company policies.
Develops research accountability standards, metrics, and reports and identifies areas for improvement. Implement action
plans designed to improve practice research operations and quality assurance functions.
Collaborates with practice management staff in the development and implementation of research budget that includes accrual
targets and financial objectives. Develops accountability standard to ensure that targets and budgets are achieved.
Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program.
Responsible to promote or market research program to the practice, community and referring physicians.
Responsible for coordinating research activities with other (non-USOR) bases or sponsors.
Requirements
Minimum Job Qualifications (Knowledge, Skills, & Abilities):
Education/Training:
Bachelors degree in a clinical or scientific related discipline desired, Bachelors degree in nursing preferred.
Business Experience:
Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology
Minimum of 2 years of supervisory experience preferred, experience in clinical research preferred
If required for state of practice, current licensure as a registered nurse (RN)
SoCRA or ARCP certification preferred
Specialized Knowledge/Skills:
Excellent communication skills, strong ability to multitask
Strong interpersonal skills
Must be able to work in a fast paced constantly changing environment
Knowledge and proficiency in all basic computer programs, windows, excel etc.
Special knowledge of GCP and ICH guidelines
Specific knowledge of all aspects of clinical research - ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions
Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails
Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle
Working Conditions:
Traditional office environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.) -
Large percent of time performing computer based work is required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination.
Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
(This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)
Director, Clinical Research Scientist
Clinical research coordinator job in New York, NY
Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs.
The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists.
Job Responsibilities
Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy
Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA)
The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience
May co-lead study team meetings in partnership with Clinical Operations study lead
Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting.
Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs)
Provides strategic clinical science support for assigned studies and programs
Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
May author and/or review clinical narratives in conjunction with pharmacovigilance
in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians
In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts)
As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists
Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff.
As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
Core Competencies
Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally
Outstanding written communication skills
Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points
Comfortable working in fast paced entrepreneurial environment
Ability to travel up to 20%
Education and Experience
Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred)
Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials
experience in CAR T-cell therapy is preferred
Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols
Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research
Physical Requirements
In office 4 days per week, required
Sedentary, desk position
Salary Range
$175,000-225,000 (final salary is dependent on candidate's experience and credentials)
Auto-ApplyClinical Research Scientist (EZIJP00002334)
Clinical research coordinator 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 clinical research in the pharmaceutical industry
• A thorough understanding of clinical research 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 clinical research 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
Clinical Research Associate
Clinical research coordinator job in South Plainfield, NJ
A Few Words About Us - 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), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
The Clinical Research Associate for Clinical Operation will provide site monitoring and management oversight across multiple clinical research trials in support of development of Pharmaceutical's drug pipeline. This position will report to Associate Director of Clinical Operations and be responsible for operational support for clinical studies and related activities in accordance with company standard operating procedures, good clinical practice, and applicable regulatory requirements.
JOB RESPONSIBILITIES:
Support project management oversight of Clinical Development activities for multiple domestic and international trials, including:
Track study timelines;
Review and track study budgets;
Provide periodic updates on Clinical Development
Gradually develop responsibilities for management of contract research organization (CROs) activities for clinical and data management
Provide monitoring support, in some cases functioning as the primary site monitor.
Assist in writing and review of protocols, amendments, and informed consent forms. Manage development of study-specific guidelines (Case Report Forms, Monitoring Plans, and Pharmacy Manuals, etc.)
Collaborate with Quality Assurance Department in development of Clinical Development standard operating procedures (SOP).
Perform investigative site training
Review CRO, vendor, and internal SOPs to ensure consistency and proper delegation of responsibilities among study teams.
Assist in development of vendor relationships with CROs, drug depots, country-specific laboratories, and other vendors, as needed.
Provide internal support for site recruitment activities.
Oversee Trial Master File maintenance and reconciliation.
Provide support to Regulatory Department in regulatory activities including submissions, and review of regulatory documents.
Ensure compliance with FDA regulations and ICH Good Clinical Practice guidelines, as well as country-specific guidelines.
Ensure compliance with study-specific procedures. Ensure compliance with study-specific procedures.
KEY CONSIDERATIONS:
Collaborate in a cross-functional environment in a small biotechnology company to assist in the initiation and coordination of global clinical initiatives and strategies.
A strong background as a clinical research associate (CRA), specifically site monitoring or, alternatively; a nursing background would be noteworthy, particularly if the candidate has worked as a nurse at a research site.
A therapeutic background to complement our pipeline, i.e. Cardiovascular, Hematology, Oncology, Pulmonology.
Well-versed in Good Clinical Practices, medical terminology, and standard study procedures.
Experience with electronic data capture systems.
Good quality background and experience with healthcare or pharmaceutical development is required.
Must be driven to deliver quality results on time and in a highly ethical and professional manner;
Candidate must be willing to travel internationally (up to 25-50%, potential more depending on enrollment).
Great organizational and communication skills.
Proficient in use of Microsoft Office applications.
Qualifications
Thorough knowledge of Good Clinical Practice, clinical trial design, regulatory processes, and global clinical development process.
3-5 years of investigative site monitoring or study coordinator/study nurse experience.
Hands-on experience in data cleaning and analysis required.
Proven ability to work independently, to lead a multidisciplinary trial team.
Proven experience in developing effective relationships with key investigators.
Ability to maintain effective working relationships with coworkers, managers, as well as investigative site personnel.
EDUCATION: Undergraduate Degree
Additional Information
Kind Regards
Kavita Kumari
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
Direct Line : 732-549-5302 Ext 208
www.irionline.com
Clinical Research Associate II
Clinical research coordinator job in Newark, NJ
Responsible for providing Clinical Research 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 clinical research 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
1 -2 years of clinical research experience or equivalent experience or training
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
BenefitsDental, Medical, Vision and 401K
Clinical Research Specialist
Clinical research coordinator job in New York, NY
Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia), and Europe (Ireland, Netherlands, Poland, United Kingdom).
We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers.
Not only are we committed to meeting and exceeding our customer's needs, but also are committed to our employees' satisfaction as well.
We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera.
As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for five consecutive years since 2012. Collabera has over 50 offices across the globe with a presence in ten countries and provides staff augmentation, managed services and direct placement services to global 2000 corporations.
For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning.
Visit ***************** to learn more about our latest job openings.
Awards and Recognitions
--Staffing Industry Analysts: Best Staffing Firm to Work For (2016, 2015, 2014, 2013, 2012)
--Staffing Industry Analysts: Largest U.S. Staffing Firms (2016, 2015, 2014, 2013)
--Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US.
Job Details:
Job Title: Clinical Research Specialist
Location: Manhattan, NYC
Duration: 6 months (could go beyond)
Job Description:
·
Job function includes, study coordination and implementation of a new clinical study.
·
The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies.
·
The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of clinical studies. It is a full time position, Monday-Friday.
Positive candidate must possess the following:
·
Experience as a study coordinator 1-2 years in a hospital or outpatient setting, preferably with imaging trials, and EDC systems.
·
High organizational ability with strong attention to detail
·
Flexibility with a team player attitude
·
Professionalism
·
Proficient with MS Office, Outlook and Internet Explorer
·
Critical thinker and problem solver
·
Please include a cover letter with your resume.
Qualifications
Education Requirements : 4 yr Bachelor's Degree. Clinical research experience required.
Additional Information
To know more about this opportunity, please contact:
Ujjwal Mane
************
****************************
Easy ApplyClinical Research Associate II
Clinical research coordinator job in Bridgewater, NJ
Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.
Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Clinical Research Associates II for coverage on the East Coast (Eastern time zone), Central Region (Central time zone), or West Region (Pacific or Mountain time zone). The incumbents may be required to travel to other locations across the USA to support monitoring activities as necessary.
Key Accountabilities:
Interact with personnel from study Sponsors, investigational sites, vendors, and Everest functional groups to enable quality and on-time execution of clinical trials in compliance with ICH-GCP and relevant local regulations.
Identify potential sites for participation in clinical trials.
Perform protocol/site feasibility and Pre-Study Visits to recommend qualified sites.
Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related questions as needed.
Provide feedback to study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as needed.
Perform Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.
Submit quality and on-time Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).
Complete monitoring visit reports and follow-up letters, including summaries of the significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.
Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.
Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
Establish regular lines of communication and administer ongoing protocol/study-related training to assigned sites.
Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification). Assess the clinical research site's patient recruitment/retention success and offer suggestions for improvement.
Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.
Prepare sites for inspections/audits conducted either by regulatory authorities, Sponsors, or Contract Research Organizations.
Submit accurate and on-time expense reports.
Assist with preparation of materials for Requests for Proposals and bid defenses.
Assist the Clinical Operations team with additional related tasks as needed.
Plan and carry out professional development.
Complete timesheets as requested and on-time.
Qualifications and Experience:
Bachelor's degree in a Life Science or related field of study.
Minimum of 4 years' of relevant and/or monitoring experience.
Thorough knowledge of ICH-GCP guidelines and applicable regulations.
Thorough comprehension of medical terminology.
Excellent organization and communication skills (both verbal and written).
Ability to travel a maximum of 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits.
Must maintain a valid driver's license and be able to drive to monitor sites.
To find out more about Everest Clinical Research and to review other opportunities, please visit our website at ****************
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.
#LI-Remote
#LI-MG1
Clinical Research Scientist
Clinical research coordinator job in Madison, 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
MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization
• MS: 3 to 5 years of clinical development/clinical trial management
• BS: 5 to 8 years with industrial or CRO clinical experience
Experience in writing clinical portions of regulatory dossiers highly preferred
• Knowledge of drug development (all clinical research process including protocol and case report form design, etc)
• Knowledge of GCP/ICH guidelines and FDA regulations
Additional Information
$60/hr
12 MONTHS
UX Research Coordinator
Clinical research coordinator job in New York, NY
About the Job: The Research Coordinator's role is to help the research practice operate more efficiently. They do this by handling the logistics to make research run smoothly so that researchers can focus on what they do best - conduct research. Research Coordinator duties may include project and client management, creating and managing materials for research, participant recruitment and session scheduling, incentive management, tool and data management, etc.
What You'll Do:
* Coordinate research participant recruitment
* o Identify and recruit research participants per researcher specifications
* o Coordinate schedules of research participants, researchers, and stakeholders
* o Manage incentives
* o Manage lists of past and future research participants
* Manage software systems used for data collection and analysis
* Coordinate with Design Program Managers, Design Leads, and other stakeholders
* Work as part of the larger Design Operations team and may be called upon to do operational work for the broader design organization.
* If capacity allows, manage projects across the research organization. Including
* o Prepare study materials and data collection tools for research sessions
* o Schedule planning, research, and report-out sessions for researchers
* o Prepare data for analysis
* o Create and manage data repositories and handle records retention
Skills You Have:
* Bachelor's degree, or equivalent
* Experience providing operational support to fast-paced research teams.
* Experience with research participant recruitment
* Demonstrated skills in increasing team efficiency.
* Strong communication and organizational skills with attention to the right details to ensure operations run smoothly
* An ability to anticipate and proactively solve logistical issues so your team knows they'll never miss a beat when you're coordinating their work
Additional Qualifications We'd Love:
* 2 years' experience collaborating with live research teams.
* Experience working in a highly regulated environment like healthcare or financial services.
* Professional association with the Research Ops community.
#LI-Hybrid
Compensation Range:
Pay Range - Start:
$60,340.00
Pay Range - End:
$112,060.00
Geographic Specific Pay Structure:
Structure 110:
$66,360.00 USD - $123,240.00 USD
Structure 115:
$69,370.00 USD - $128,830.00 USD
We believe in fairness and transparency. It's why we share the salary range for most of our roles. However, final salaries are based on a number of factors, including the skills and experience of the candidate; the current market; location of the candidate; and other factors uncovered in the hiring process. The standard pay structure is listed but if you're living in California, New York City or other eligible location, geographic specific pay structures, compensation and benefits could be applicable, click here to learn more.
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Auto-ApplySenior Clinical Research Coordinator
Clinical research coordinator job in New Brunswick, NJ
Job Description
WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.
We are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients' mission to impact and save lives.
Reasons to work for Vitalief:
You can actively contribute to our clients' mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
We give everyone a seat at the table - we encourage innovation.
Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.
Salary Range: Market competitive - based on experience level.
Work Location: New Brunswick, NJ. Four (4) days on-site and one (1) day remote on a weekly basis.
Responsibilities:
Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Phase 1 Oncology trials.
Serves as a liaison (Communicating effectively) between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors - to ensure that services are coordinated and delivered to patients in a timely manner.
Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials.
Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms.
Schedules and conducts trial visits by informing patients and coordinating procedures per protocol.
Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol.
Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies.
Required Skills:
Bachelor's Degree required.
Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol.
Oncology clinical research experience is a huge plus.
Phase 1 clinical research experience is a plus.
Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines.
Compassionate personality and ability to interact with patients in a clear and confident manner.
Ability to work on several trials concurrently - can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills.
Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner.
Needs to be communicative and responsive and know when to escalate and communicate issues to management.
Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently.
Must have strong Microsoft Office skills.
Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
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Clinical Research Associate
Clinical research coordinator job in Franklin Lakes, NJ
Clinical Research Associate Duration : 12 +months contract Start Time : 08:00 AM End Time : 05.00 PM Total Hours/week : 40.00 Qualifications:
The Clinical Research Associate (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
Clinical Research Scientist
Clinical research coordinator job in Summit, NJ
Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity.
To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com
Job Description
CORE JOB RESPONSIBILITIES:
Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
Assist with clinical study report preparation to include narrative writing
Participate in adhoc meetings
Qualifications
KNOWLEDGE/SKILLS/ABILITIES (KSA's):
Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent
Oncology experience REQUIRED. Hematology experience is a plus. Protocol authoring is a plus. Data review and medical monitoring of data REQUIRED.
Minimum 5 yrs experience in oncology clinical development
Excellent written and verbal communication skills and interpersonal skills.
Knowledge of clinical trial design, basic statistics, and data review tools
Proficient at data interpretation
Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
Full understanding GCP and ICH Guidelines
Detail-oriented, well-organized
Ability to assimilate technical and scientific information quickly
Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave)
Demonstrated ability to work as part of a team
Additional Information
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP!
I look forward to hearing from you!
Clinical Research Scientist
Clinical research coordinator 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 Clinical Research 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 clinical research 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 Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research 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
Clinical Research Scientist
Clinical research coordinator job in Iselin, NJ
Clinical Research Scientist Early Development We are seeking a motivated Clinical Research Scientist to join our Clinical Development team and support the execution of innovative clinical studies. This individual will work closely with senior scientists, physicians, and cross-functional partners to contribute scientific expertise, data insights, and clinical input across multiple programs.
Key Responsibilities
Assist in the design and development of study protocols and protocol amendments.
Contribute to the preparation of clinical and regulatory documents, including sections of INDs, study reports, investigator brochures, and updates for health authorities.
Provide scientific input into study tools such as case report forms, statistical analysis plans, and data output specifications.
Participate in the review and interpretation of clinical safety and efficacy data;support data monitoring activities throughout study conduct.
Collaborate with internal study teams and external partners (CROs, vendors, investigators) to ensure high-quality study execution.
Present study progress and scientific updates to project leadership and cross-functional committees.
Support preparation of data for abstracts, posters, presentations, and manuscripts.
Stay informed on evolving therapeutic landscapes, competitive intelligence, and standards of care relevant to assigned programs.
Qualifications
Advanced degree in a life science discipline preferred (Pharm.D., Ph.D., or equivalent).
1 3 years of experience in clinical research, with at least 1 year in drug development or industry setting.
Background in oncology or hematology is a plus.
Strong analytical skills and attention to detail, with ability to interpret and communicate complex data.
Excellent organizational, written, and verbal communication skills.
Ability to work effectively in a fast-paced, collaborative environment and manage multiple priorities.
Willingness to travel occasionally (up to ~20%).
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
Clinical Research Scientist
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 clinical research in the pharmaceutical industry
• A thorough understanding of clinical research 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 clinical research 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 clinical research in the pharmaceutical industry
Additional Information
All your information will be kept confidential according to EEO guidelines.
Clinical Research Coordinator I (Yonkers, NY)
Clinical research coordinator 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 into 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 clinical research 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 Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research 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 Clinical Research 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. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off.
Benefits & Perks
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: ********************************
Research Coordinator
Clinical research coordinator job in New York, NY
* Job Type: Support Staff - Non-Union * Regular/Temporary: Regular * End Date if Temporary: * Hours Per Week: 25 * Salary Range: $52,000- $65,000 The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Hunt Molecular Biophysics Laboratory at Columbia University lab uses structural, thermodynamic, enzymological, and computational methods to understand the molecular mechanisms of complex biochemical processes.
Hunt Lab is seeking a part-time scientific Research Coordinator position for a project focused on engineering the amino acid and nucleotide sequences of a human protein for use in genetic therapies. The major job responsibilities are coordinating communication and data interchange between four participating laboratory groups at different institutions, managing a publicly accessible project database, and assisting with related grant-reporting and manuscript-writing activities.
This is a part-time role, subject to grant funding.
Responsibilities
Project Communication & Coordination
* Serve as the primary liaison between project participants.
* Coordinate biweekly Zoom meetings and follow up on action items.
* Maintain consistent communication flow to ensure alignment across all sites.
* Oversee and coordinate inter-site sample shipments.
* Track sample inventory and ensure proper handling and documentation during transit.
* Assist with the preparation and submission of progress reports to the funding agency.
Data and Website Management
* Coordinate the timely posting of data on the project website.
* Ensure proper versioning and data labeling for easy accessibility.
* Assist project staff in preparing data for upload to publicly accessible databases.
* Make basic content and format updates to the project website.
* Organize project resources and data presentations as guided by the team.
* Ensure that the website is updated with the latest findings, protocols, and relevant documentation.
Final Data Deposition
* Oversee the deposition of final results into publicly available databases.
* Assist staff with formatting and submission requirements.
* Ensure compliance with funder and institutional data-sharing policies.
Minimum Qualifications
* A bachelor's degree is required in a scientific discipline.
* A minimum of three years of experience is needed in a research environment.
Preferred Qualifications
* Master's or PhD degree strongly desirable.
* Rudimentary computer programming skills.
* Comfort using a standard computer database system.
* Two years of continuous laboratory research experience in a related scientific field.
Other Requirements
* Basic familiarity with research-level molecular and cellular biology and protein structure studies.
* Excellent written, verbal, and interpersonal communication skills.
* Ability to maintain high confidentiality and professionalism with a client focus.
* Strong multi-tasking, prioritization, and organization skills.
* Attention to detail, research, critical thinking, analytical, and problem-solving skills.
* Self-starter, a fast learner who can work independently under limited supervision.
* Work well in an interactive team environment.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
AI-Search Coordinator - Research, Strategy & Analytics (NJ)
Clinical research coordinator job in Jersey City, NJ
Idea Evolver is seeking a forward-thinking AI-Search Coordinator to join our growing team. This is not your typical SEO role-we're looking for someone who understands people and integrates AI into their everyday workflow. As part of our team, you'll explore how audiences discover information across both traditional and emerging AI-driven platforms, translating those insights into strategies that drive content performance and client growth. You'll collaborate closely with leaders in healthcare and other regulated industries to help them adapt to the future of AI-driven digital discovery.What You'll Do
Conduct advanced search behavior research using our AI-powered platform, SEMrush, Google Search Console, and other leading tools.
Leverage AI to streamline research, surface patterns, and deliver actionable insights faster.
Transform search and performance data into clear, compelling stories and recommendations for clients.
Support technical SEO best practices to ensure websites meet modern performance, accessibility, and indexability standards.
Monitor and interpret performance metrics (via Google Analytics and other platforms), delivering optimization strategies that move the needle.
Stay at the forefront of AI-driven search and conversational experiences, helping clients position their content for visibility in these new discovery environments.
Deliver client-ready materials-reports, roadmaps, presentations-that drive meaningful business outcomes.
What We're Looking For
A human who loves what they do and is energized by solving complex problems.
A human who wants to contribute to building AI solutions for search and content discovery.
4+ years of experience in SEO, search analytics, or related digital marketing roles.
Outstanding communication skills-able to turn complex insights into engaging, client-friendly narratives.
Proven ability to collaborate across disciplines in fast-moving, data-driven environments.
Experience in healthcare, life sciences, or other regulated industries is a plus.
Why Join Idea Evolver
Collaborate with a forward-thinking agency at the forefront of AI and search innovation.
Partner with high-profile clients in healthcare and consumer industries.
Be part of a collaborative, growth-oriented culture where your ideas directly influence outcomes.
Enjoy competitive compensation, comprehensive benefits, and opportunities for professional development.
Ready to help shape the future of AI-powered search?
Apply today to join Idea Evolver's AI-Search & Analytics team and lead the charge into the next era of digital discovery.
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