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
Senior Clinical Research Coordinator
Clinical research coordinator job in New York, NY
Clinical Research Coordinator
Brooklyn Clinical Research was founded to increase access to clinical trials for underrepresented populations. Clinical-trial enrollment should accurately represent the broader population. In meeting this objective, we help improve therapeutic efficacy and safety for all individuals.
The Senior Clinical Research Coordinator (“SCRC”) monitors all data management, regulatory and financial aspects of clinical-trial operations and ensures that research is conducted in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines. The SCRC will also ensure that the data provided to the sponsor are of the highest quality and that study enrollment meets or exceeds the sponsor's expectations. As such, the SCRC should be a detailed-oriented, experienced coordinator with a track record of successfully adhering to clinical-trial protocols and exceeding sponsor expectations.
Responsibilities
• Completing all relevant training prior to study start and all additional protocol-amendment trainings.
• Adherence to ALCOA-C Standards with all clinical trial documentation.
• Working effectively with EDC, CTMS, eISF, and HubSpot.
• Working effectively with sponsor specified IVRS, EDC, eDiary, ePayment, and additional study related systems.
• Conducting and overseeing study participant visits, and all other relevant protocol-required procedures while documenting relevant data in a timely, accurate manner.
• Completing and overseeing data entry and query resolution in a timely manner as per company guidelines and sponsor expectations.
• Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
• Liaising with the administrative staff, clinical investigators, research participants and Sponsor/CRO representatives for assigned protocols.
• Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
• Training and mentoring junior staff.
• Preparing for monitoring visits for their respective protocol(s).
• Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed Consents, Study Manuals, and all the other relevant study-related documents that are utilized for the assigned protocols.
• Maintaining a working knowledge of study participants' scheduling, visit tracking, stipends, and transportation by liaising with our administrative staff.
• Maintaining a working knowledge of all essential clinical trial documents and maintenance of the Investigator Site Binders for their assigned protocol(s).
• Work with the Principal Investigator(s) on the reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per Sponsor, IRB, and ICH-GCP Guidelines.
• Traveling to industry conferences and meetings when necessary.
Qualifications
Education:
• Bachelor's degree in health or science-related major preferred.
• ICH-GCP Certification and IATA Certification.
Experience:
• 3+ years' experience in clinical research.
• Supervisory experience preferred.
• Wide therapeutic range of clinical-trials experience preferred.
• Regulatory experience is a plus.
Knowledge and Skills:
• Goals-driven while continuously maintaining quality.
• Must be a detail-oriented and proactive self-starter.
• Must have strong written and verbal communication skills.
• Must have excellent customer service skills.
• Bilingual in Spanish is a plus but is not required.
Starting Salary Range: $87,500 - $95,000
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.)
Coordinator, Fabric R&D of Denim & Woven Bottoms
Clinical research coordinator job in New York, NY
Title: Coordinator, Fabric R&D of Denim & Woven Bottoms Reports To: Manager, Fabric R&D
About American Eagle American Eagle is a youth culture brand grounded in denim. Our purpose extends beyond making the best jeans-we embrace self expression, culture, optimism and connection. Through the brand platform Live Your Life, we empower our community to be who they want to be all while wearing the clothes that make them most confident.
Get to Know the Role:
Coordinate raw material sourcing and development for our AE denim and woven bottoms fabric categories. Source and develop category-appropriate fabrics that meet the timeline, quality, fit for purpose, price point, and aesthetic guidelines established by CFT partners for each category.
What You'll Do:
Source and develop trend-right, brand-appropriate materials
Help to acquire seasonal collections from the supply base or set up appointments to review collections when possible. Identify items that meet seasonal needs and present to design team for selection
Oversee the development of materials that are designed in-house by the AE design teams
Acquire testing documents from suppliers to ensure materials meet industry and AEO standards
Research trends in raw material design and innovation.
Maintain daily communication with the supply base.
Adhere to seasonal development calendar with internal and external partners; elevate issues to manager as needed
Work to ensure milestone deadlines are met and that needed information is obtained from CFT partners on time
Pre-position key materials to ensure on-time sample execution; arrange substitute materials as necessary
Ensure that suppliers submit materials for approval on time and comply with all development deadlines
Promote efficiency and effective problem solving with suppliers and internal teams to meet development and production deadlines
Actively participate in key milestone meetings with design, production and merchants
Support financial goals for each category
Partner with PD and production teams to ensure that new development meet the pricing and MOQ/MCQ needs of each category
Provide cost-engineering options for items that do not meet IMU targets
Re-source materials as needed to meet financial targets
Maintain material library and internal records database
Obtain Material Profile Sheets for all items sampled and organize all records on internal shared drive. Ensure information on profile sheets is updated as needed
Update and maintain development chart through handoff to Production Teams
Create PLM codes for sampled materials in Tradestone
Ensure that the material library is up-to-date and organized.
Other projects and responsibilities as assigned
What You Bring:
Bachelors' Degree in Fashion or Textiles; 2-4 years of related experience
Denim experience a plus
High degree of proficiency MS Office Suite, Outlook & Internet applications
Strong analytical, interpersonal, problem-solving, presentation, and project management skills
Strong verbal and written communication skills
Demonstrated collaborative skills and ability to work well within a team
Ability to work with and influence peers in a fast-paced, deadline-oriented environment
Self-motivated with critical attention to detail, deadlines and reporting
Comfortable working in an hybrid environment - working in office a few days a week (based on the needs of the business or big milestone week) with occasional remote work from home
Perks: Why You'll Love it Here
Generous employee discount
Summer Fridays
Casual dress code
Hybrid schedule
FOMO events (Exciting company-wide events)
Gym Discounts
Competitive Company Bonus
Internal Mobility & Growth
Pay/Benefits Information:
Actual starting pay is determined by various factors, including but not limited to relevant experience and location.
Subject to eligibility requirements, associates may receive health care benefits (including medical, vision, and dental); wellness benefits; 401(k) retirement benefits; life and disability insurance; employee stock purchase program; paid time off; paid sick leave; and parental leave and benefits.
Paid Time Off, paid sick leave, and holiday pay vary by job level and type, job location, employment classification (part-time or full-time / exempt or non-exempt), and years of service. For additional information, please click here.
AEO may also provide discretionary bonuses and other incentives at its discretion.
Auto-ApplyClinical 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
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 aretas: 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 Client'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.
Requirements-
• 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.
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 co-workers, managers, as well as investigative site personnel.
• Undergraduate Degree Field of study: Health/Life Sciences, Medical Technology, Biochemistry, or Microbiology.
Additional Information
Warm Regards
Ricky Bansal
732-429-1925
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 Associate
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
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 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 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 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 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 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.
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.
Grow your career with a best-in-class company that puts our clients' interests at the center of all we do. Get started now!
Northwestern Mutual is an equal opportunity employer who welcomes and encourages diversity in the workforce. We are committed to creating and maintaining an environment in which each employee can contribute creative ideas, seek challenges, assume leadership and continue to focus on meeting and exceeding business and personal objectives.
Auto-ApplyRegulatory Clinical Scientist
Clinical research coordinator job in New York, NY
Aidoc helps health systems deliver smarter and faster care when it matters most. Its mission is to transform patient outcomes through 'always on' clinical AI, eliminating preventable care gaps that lead to loss of lives and disabilities. Through our proprietary ai OS platform, Aidoc seamlessly integrates real-time intelligence into provider workflows, helping physicians make faster clinical decisions for over 45 million patients a year. With the most FDA-cleared AI solutions in its category and deployments across 150+ health systems globally, Aidoc elevates the physician and patient experience.
Backed by General Catalyst, Square Peg, NVentures (NVIDIA's venture arm), and four major U.S. health systems, Aidoc has raised $370 million to date, including a recent $150 million round to accelerate development of CARE, its clinical-grade foundation model.
About this role
This position focuses on shaping and advancing pivotal study design strategy for AI-enabled medical devices.You will be responsible for designing and authoring pivotal study protocols, as well as planning, writing, and executing pivotal study reports that demonstrate clinical value and align with regulatory requirements. This role requires both creative and critical thinking, balancing established, well-tested study methodologies with innovative approaches enabled by large-scale real-world data and Aidoc's solution deployments. You will collaborate closely with product, regulatory, clinical, and AI teams to establish new paradigms for clinical evidence generation in a rapidly evolving field.
This position is located in the US (remote) or Israel.
Responsibilities
* Lead the design of pivotal clinical studies, incorporating both traditional and novel approaches to study design.
* Write, edit, and manage pivotal study protocols, statistical analysis plans, and study reports.
* Partner with product, regulatory, and AI teams to align study design with product strategy and regulatory requirements.
* Develop innovative real-world study designs that leverage large-scale Aidoc implementations.
* Perform and interpret statistical analyses to inform study design and study outcomes.
* Contribute to the preparation of regulatory submissions, including pivotal study documentation.
* Stay abreast of evolving clinical research methodologies and regulatory guidance, particularly in AI-enabled medical devices.
Requirements
* Advanced degree (Masters or PhD) in Biostatistics, Epidemiology, Clinical Sciences, or related field.
* 3+ years experience navigating AI study designs and regulatory expectations for AI-driven devices.
* Demonstrated expertise in clinical research design and statistical analysis.
* Proven ability to write and manage clinical study protocols and study reports.
* Strong critical thinking and analytical skills with a track record of creative, outside-the-box study design approaches.
* Excellent written and verbal communication skills, with experience in scientific publications or regulatory submissions.
Strong drive to innovate and create new paradigms for clinical evidence generation in emerging device categories.
Working at Aidoc
We're a dynamic, collaborative and fast growing team of more than 400 global employees, committed to improving the world of healthcare. We're looking for mission-driven people excited to do transformative work.
We have offices in Tel Aviv and New York City, but Aidoc is a remote-first workplace. We're able to hire US-based employees across the continental United States, although certain roles may be region-specific.
What we offer:
* A range of medical, dental and vision benefits
* Stock options for all full-time employees
* 20 days of paid vacation, plus sick days and holidays
* A 401(k) plan, life insurance, plus long and short term disability
* The opportunity to directly improve medical care and impact patient outcomes
Aidoc is deeply committed to creating an inclusive and diverse workplace, and to the principle of equal opportunity for all individuals. We prohibit harassment of any type as well as discrimination based on race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, or any other status protected by law.
Clinical Research Coordinator I (Yonkers, NY)
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 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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