Clinical Scientist
Clinical research coordinator job in Clark, NJ
Job Title: Scientist I - pharmacovigilance
Job Duration: 12 Months Contract - W2
Note:
Backfill
Onsite role
Job Description:
As a Scientist in our Post Market Safety & Cosmetovigilance team, your main responsibilities are:
• Prioritization of workload for US OTC/Medical Devices (MD) & Hospital visit cases, data entry, MedDRA coding and completion of case narratives of incoming potential Health Related Complaints (HRCs) into the Post-marketing Safety (PMS) database while ensuring completeness and legibility.
• Reconciliation of daily cases received from Consumer Care Center (CCC), identify missing cases, correct errors in the Salesforce database & notify CCC manager of discrepancies.
• Provide feedback using discretion regarding database issues or with case details that are documented by CCC and communicate database discrepancies.
• Support PMS team members with projects regarding completion of cases with missing data or formula numbers as needed and serve as a backup for preparing statistical reports.
• Perform data extractions for global PMS analyses and validate data.
• Provide ongoing training/feedback of operating tools coordinating with colleagues in France to ensure accuracy.
• Provide prompt queries of vendor's database to review all AEs received, notify appropriate partner contacts, review for potential quality-related complaints, notification of manufacturing sites, while maintaining appropriate recording and archiving of information.
• Conduct database and data entry training of PMS newcomers within the Americas zone.
• Ensure documentation management of departmental work files, including organization of department training documents, Quality Investigations, and maintenance of FDA correspondence.
• Review/update standard operating procedures (SOP) and work processes (WP) as needed.
• Participate in department presentations to CCC or other métiers.
• Ensures compliance with company policies, procedures, and standards.
• Ensuring prioritization of data entry workload (OTC/Hospital/MD cases), data exploitation/validation working with colleagues in Global Data Management, ensure department document retention, while working with other Sr. Scientists, Vigilance Coordinators & Head of Post-Marketing Safety.
To Succeed in this Position, You Have:
• A completed BS or MS in biology or a related field preferred with case processing experience & relevant data exploitation experience in pharmacovigilance.
• Minimum of 3-5 years of relevant experience.
• Experience in MedDRA coding preferred.
• Basic understanding of US Regulations pertaining to Post Marketing Safety preferred.
• Knowledge of medical terminology preferred.
• Excellent communication (verbal, written) and interpersonal skills required.
• Well organized while handling multiple projects simultaneously.
• Demonstrated skills in analyzing, reporting, and documenting information with strong attention to detail.
• Ability to work independently with minimum supervision in a matrix environment.
Clinical Trial Associate - Consultant
Clinical research coordinator job in Somerset, NJ
Clinical Trial Associate - Consultant (No third parties or C2C)
*This role is with a global pharmaceutical company located in NJ. Mandatory 3 days per week onsite*
Key Responsibilities:
Coordinate meetings, including scheduling, agenda preparation, and minute-taking.
Gather data for feasibility assessments and site selection, and maintain site usability records.
Review study documents (e.g., informed consent forms, case report forms) in compliance with SOPs.
Assemble and update study manuals and maintain version control of study materials.
Monitor site activation, enrollment, and study progress, and escalate any issues or deviations.
Maintain investigator and site status updates, and support clinical trial registry postings.
Perform regular reconciliations of the Trial Master File (TMF).
Ensure timely receipt of required reports (e.g., 1572 changes, financial disclosures).
Manage team SharePoint or shared drive sites and maintain site contact information.
Assist in managing third-party vendors and tracking study close-out activities.
Participate in SOP revisions and propose process improvements.
Qualifications:
Strong attention to detail and ability to manage study activities effectively.
Good communication and interpersonal skills.
Problem-solving abilities and proactive approach to tasks.
Familiarity with trial management systems and MS Office applications.
Basic understanding of clinical drug development and ICH/GCP guidelines.
Experience:
Bachelor's degree with 5+ of relevant experience
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 Project Manager
Clinical research coordinator job in Trenton, NJ
Base Salary: $150K USD + Bonus | Full-Time | Remote
Globally recognized, publicly traded full-service CRO that's redefining clinical research across continents. With a footprint in over 30 countries and a workforce of 10,000+, this organization partners with thousands of biopharma and medtech innovators to bring cutting-edge therapies to market. From oncology to rare diseases, their pipeline is as diverse as their team. Leveraging AI-powered platforms and real-world data, they're not just conducting trials-they're shaping the future of medicine. If you're a Clinical Project Manager looking to lead global studies in a collaborative, tech-forward environment, this is your chance to thrive.
Key Responsibilities
Lead and manage global Phase I-IV clinical trials across cardiovascular and oncology indications
Oversee cross-functional teams including biometrics, regulatory affairs, medical writing, and pharmacovigilance to ensure seamless trial execution.
Develop and maintain project timelines, budgets, and risk mitigation strategies.
Serve as the primary point of contact for sponsors, vendors, and internal stakeholders.
Ensure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements.
Utilize AI-enabled tools and platforms to optimize trial design and operational efficiency.
Contribute to business operations including budgeting, forecasting, and resource planning.
Mentor junior team members and foster a culture of excellence and innovation.
Qualifications
Minimum 10 years of experience in clinical research, with at least 6 years as a Clinical Project Manager.
Must have direct experience managing both cardiovascular and oncology studies.
Experience across multiple phases, preferably Phase II-III.
Global trial management experience is essential.
CRO experience strongly preferred.
Strong understanding of drug development processes and clinical trial regulations.
Valid and current GCP certification required.
Solid knowledge of local regulatory requirements in the U.S. and/or EU.
Proven experience in budgeting and business operations related to clinical project management.
Excellent communication, leadership, and problem-solving skills.
If you or someone you know fits this experience and shows interest, we'd love to speak with you!
Administrative Researcher
Clinical research coordinator job in New York, NY
Atlantic Group is seeking a detail-oriented and proactive Administrative Researcher to support our Accounting & Finance recruiting team. This role is ideal for someone who enjoys research, organization, and playing a behind-the-scenes role in driving team productivity and accuracy. You'll work closely with recruiters and leadership to manage data integrity, conduct market and candidate research, and assist in daily administrative tasks that help streamline the recruiting process.
Responsibilities:
Conduct research on potential candidates across LinkedIn, internal databases, and industry-specific platforms.
Maintain and update candidate and client records in Bullhorn (our CRM system) to ensure data accuracy.
Support recruiters by building and maintaining targeted candidate lists for ongoing searches.
Assist with tracking candidate pipelines, interview schedules, and submission logs.
Prepare weekly activity reports and dashboards for the team.
Provide ad hoc administrative support, including calendar coordination, database updates, and report generation.
Conduct basic market mapping and research to identify new business prospects and hiring trends.
Collaborate with the recruiting team to identify process improvements and increase workflow efficiency.
Qualifications:
Bachelor's degree required.
Strong attention to detail and organizational skills.
Excellent written and verbal communication.
Proficient with Microsoft Excel, Google Workspace, and LinkedIn.
Interest in recruiting, finance, or business operations.
Positive attitude, curiosity to learn, and a team-oriented mindset.
Clinic Coordinator - (Mon-Fri 11:30am-8pm)
Clinical research coordinator job in Belmont, NY
Clinic Coordinator
Location:450 Brookline Ave, Boston, MA 02215 Category:Administration Support/Customer Service Employment Type:full time
Clinic Coordinators demonstrate the values and mission of Dana-Farber everyday by providing expert compassionate care to our patients with cancer.
Responsibilities:
Create an exceptional patient experience by delivering outstanding customer service throughout the check in and check out process.
Manage complex scheduling to meet patient needs.
Act as a liaison for patients, families and providers.
Respond to emergent and compliance matters with creative problem solving and critical thinking.
Qualifications
Bachelor's degree preferred.
0 - 1 year experience in a customer service setting.
Proficiency in technology and complex computer systems required.
Ability to work in a fast paced and complex clinical environment.
Professional Growth:
The Clinic Coordinator position may lead to career opportunities in administrative, team lead, and management roles. Dana-Farber is committed to offering a variety of personal, professional, and leadership development opportunities to all members of its workforce to meet the everchanging needs of our workforce and our industry.
Well-Being and Benefits
Health, Dental and Vision Insurance
Time Off
Family & Child Care Benefits and Resources
Retirement Programs
Life Insurance
Short Term Disability
Health Savings Account
Flexible Spending Account
Transportation
LGBTQ+
Our Benefits Partners Include:
Harvard Pilgram Health Care
Delta Dental
Eye Med
Fidelity Investments
Sentinel Benefits Group
Prudential
Voya Financial
TIAA
Care.com
Edukate
Headspace
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Join Our Talent Network
Stay connected with Dana-Farber and receive alerts with new job opportunities and news relative to your interests.
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 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 Scientist
Clinical research coordinator job in Woodcliff Lake, NJ
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
Title: Clinical Research
Scientist
Duration: 12 Months (Possibility of Extension)
Location Woodcliff lake NJ
Job Responsibilities:
The incumbent is responsible for, but not limited to the following:
Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
Performs literature search and data analysis to address research questions
In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
Assisting in database cleaning, review of study results, and interpretation of results
Adhering to key performance indicators for clinical study development, conduct, and reporting
Individual contributor with specialized knowledge
Presents concepts, facts, and reports and advises on key trends and issues
Troubleshooting routine site inquiries
Work is completed under limited supervision
Supports the planning, execution and reporting of clinical programs/trials
May handle multiple protocols simultaneously
Contributes to risk resolution by escalating and monitoring project risks
Qualifications
Qualifications
Minimum of
2-5 years of experience in 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) or MD degree preferred
.
Additional Information
Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus
Thank you for your time and consideration. I look forward to hearing from you!
Kind Regards
Ruchi Kumari
Clinical Recruiter
Integrated Resources
, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE
|
GSA - Schedule 66
I
GSA - Schedule 621I
(DIRECT BOARD) #
732-844-8716
(F) 732-549-5549
LinkedIn:
https://www.linkedin.com/in/ruchi-kumari
Gold Seal JCAHO Certified ™
for Health Care Staffing
“INC
5
0
0
0
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FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
Clinical Research - Analytical Scientist II
Clinical research coordinator job in Princeton, NJ
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
* We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
* We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
The Analytical Scientist II is responsible for extracting and analyzing samples according to established procedures and SOPs.
JOB RESPONSIBILITIES
Perform all activities related to processing and analyzing biological samples.
Participate in developing and validating bioanalytical methods.
Documents the activities related to sample analysis and assist in verifying various documents.
Assist in reviewing bioanalytical and method SOPs.
Initiate analysis runs using the appropriate instruments and software.
Follows-up on result analysis and assists in finding solutions to bioanalytical issues.
Assist with the integration and revision of data using specialized computer applications.
Assist in eliminating the chemical and biological waste generated by laboratory employees and helps clean laboratory equipment and instruments.
Perform support tasks to meet the needs of laboratory users.
Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
QUALIFICATION
Bachelors or College Degree in Science.
Good understanding of bioanalytical processes used in the laboratory.
Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel and analytical software.
Knowledge of chromatography software.
Experience in regulatory context.
English level (Quebec specific); required bilingualism includes understanding simple messages and following basic instructions.
Relative alternate certification may be considered acceptable.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
***************************
Additional Information
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Clinical Research - Analytical Scientist II
Clinical research coordinator job in Princeton, NJ
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job Responsibilities
The Analytical Scientist II is responsible for extracting and analyzing samples according to established procedures and SOPs.
JOB RESPONSIBILITIES
Perform all activities related to processing and analyzing biological samples.
Participate in developing and validating bioanalytical methods.
Documents the activities related to sample analysis and assist in verifying various documents.
Assist in reviewing bioanalytical and method SOPs.
Initiate analysis runs using the appropriate instruments and software.
Follows-up on result analysis and assists in finding solutions to bioanalytical issues.
Assist with the integration and revision of data using specialized computer applications.
Assist in eliminating the chemical and biological waste generated by laboratory employees and helps clean laboratory equipment and instruments.
Perform support tasks to meet the needs of laboratory users.
Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.
QUALIFICATION
Bachelors or College Degree in Science.
Good understanding of bioanalytical processes used in the laboratory.
Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel and analytical software.
Knowledge of chromatography software.
Experience in regulatory context.
English level (Quebec specific); required bilingualism includes understanding simple messages and following basic instructions.
Relative alternate certification may be considered acceptable.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
***************************
Additional Information
Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Auto-ApplyClinical 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 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 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 - Complaint Investigator
Clinical research coordinator job in Valhalla, NY
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people.
At Ascensia, our values serve as the bedrock of our organization. They guide our decisions, actions, and interactions, shaping the culture we collectively foster.
Our Values include:
Resilient Growth Mindset
Executional Excellence
Courageous Leadership
Inclusive Collaboration
We believe that when we live our values authentically, both individually and as a team, we unlock our true potential and drive sustainable success.
POSITION PURPOSE:
Under the supervision of the Internal Clinical Trials (ICT) manager, this position will plan and perform laboratory experiments and internal clinical studies to develop new products and support existing products in the Ascensia Diabetes Care portfolio. Expertise will be provided not only for new product development, but also for external publication, regulatory submissions, and sustaining products in the commercial phase. This position will also provide support to Global Event Management (GEM) laboratory testing needs, including management of customer complaint databases.
What you will be doing:
Conduct internal clinical studies across all phases of new product development and sustainment, including frequent subject sampling via fingerstick and venipuncture.
Support project teams with exploratory and feasibility testing.
Perform experiments using both contrived and native human blood samples, ensuring all procedures and results are accurately documented.
Analyze, interpret, and report testing results clearly and concisely, providing logical recommendations for next steps.
Serve as the primary analyst for blood glucose investigations requiring fresh donor blood, including receipt, logging, and laboratory evaluation of returned products.
Manage the customer complaint database by creating, reviewing, and authoring test instructions for complaint evaluations.
Operate and maintain laboratory equipment, including clinical reference instrumentation, ensuring ongoing compliance with maintenance and audit requirements.
Adhere to Good Clinical Practice (GCP) principles at all times.
Collaborate professionally with scientific colleagues to stay informed of relevant research and company initiatives.
Protect the confidentiality of participant health information.
Perform administrative duties as needed, including report filing, invoice submission, and coordination of biohazard waste disposal.
What you need for success:
Bachelor's degree (BS or BS in Medical Laboratory Science) with a minimum of 4 years of relevant experience, or a Master's degree (MS) with at least 2 years of relevant experience.
Phlebotomy experience required; certification preferred.
Experience in the medical device or pharmaceutical industry preferred.
Strong oral and written communication skills in English required.
Demonstrated ability to collaborate effectively within multidisciplinary scientific teams.
Proven competency in experimental design, execution, and data interpretation.
TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third-party resumes.
Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.
Auto-ApplyRN - Registered Nurse - Clinical Research Coordinator II - Cancer Research
Clinical research coordinator job in Wilkes-Barre, PA
Shift:
Days (United States of America)
Scheduled Weekly Hours:
40
Worker Type:
Regular
Exemption Status:
Yes We're working to create a national model for improving health. Today, we're focused on bringing our region services that improve every facet of life to drive total health, inside and out. Through professional growth, quality improvement, and interdisciplinary collaboration, we've built an innovative culture that allows nurses to grow their skillsets, develop their practice, and leverage their years of experience to build a rewarding, lasting career with impact.
Job Duties:
Responsible for supporting clinical research as coordinator for multiple research studies and clinical trials within inpatient and outpatient care units. Serves in an expanded role to assess the appropriateness of patients for clinical research protocols. Under the direction of the physician, sees patients in the clinic and hospital to collect data required for the research protocols.
This role is full-time, 40 hours weekly; 8 am to 4:30 pm. Travel may be required to outreach clinics as needed for patient care and upon request.
A minimum of 3 years RN work experience is required. Prior Oncology and/or research experience is strongly preferred.
Job Duties:
Coordinates and implements clinical research studies.
Prepares submissions for Institutional Research Review Board consideration and provides oversight for all reporting obligations.
Responsible for conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements.
Develops and implements subject recruitment plans including interviewing subjects, collaborating with physicians, screening, and enrolling.
Performs nursing physical and psychosocial assessments of research patients in the outpatient and inpatient areas of the hospital.
Monitors research patients in outpatient and inpatient settings for adverse experiences and compliance with study protocols.
Administers and monitors study drug as directed by the investigator and clinician.
Performs triage nursing assessments of subjects as needed.
Reviews medical records of patients, interviews patients and collaborates with investigators and clinicians to assess the appropriateness of patients for clinical trial enrollment.
Develops study-specific training tools and procedures to orient patient care staff about research interventions and protocols.
Monitors lab results and reports all findings to the principal investigator.
Informs principal investigator of all relevant patient care issues and activities within research study.
Collaborates with nursing staff and research personnel to incorporate all details of research protocol.
Insures appropriate billing charge documents are submitted.
Educates staff, as needed, to insure proper billing for study-related procedures in outpatient and inpatient areas.
Reviews monthly study-specific financial statements for accuracy and budget adherence.
Provides education to subjects and family on specific research protocols, potential risks, benefits, and reporting of health events.
Serves as a liaison between the principal investigator and the study sponsor for adapting a multi-center protocol to the specific local environment.
Benefits of Working at Geisinger:
Geisinger cares about not only its patients and members, but also about you and your family. We offer a competitive compensation and benefits package to ensure that you and your loved ones can maintain good health, achieve financial stability, and excel both personally and professionally.
Full benefits (health, dental and vision) starting on day one
Three medical plan choices, including an expanded network for out-of-area employees and dependents
Pre-tax savings plans with healthcare and dependent care flexible spending accounts (FSA) and a health savings account (HSA)
Company-paid life insurance, short-term disability, and long-term disability coverage
401(k) plan that includes automatic Geisinger contributions
Generous paid time off (PTO) plan that allows you to accrue time quickly
Up to $5,000 in tuition reimbursement per calendar year
MyHealth Rewards wellness program to improve your health while earning a financial incentive
Family-friendly support including adoption and fertility assistance, parental leave pay, military leave pay and a free Care.com membership with discounted backup care for your loved ones
Employee Assistance Program (EAP): Referrals for childcare, eldercare, & pet care. Access free legal guidance, mental health visits, work-life support, digital self-help tools and more.
Voluntary benefits including accident, critical illness, hospital indemnity insurance, identity theft protection, universal life and pet and legal insurance
Position Details:
Work is typically performed in an office environment. Accountable for satisfying all job specific obligations and complying with all organization policies and procedures. The specific statements in this profile are not intended to be all-inclusive. They represent typical elements considered necessary to successfully perform the job.
Education:
Graduate from Specialty Training Program-Nursing (Required), Bachelor's Degree-Nursing (Preferred)
Experience:
Minimum of 3 years-Clinical (Required)
Certification(s) and License(s):
Licensed Registered Nurse (Pennsylvania) - RN_State of Pennsylvania
Skills:
Communication, Multitasking, Organizing, Research Regulatory Environment, Teamwork
OUR PURPOSE & VALUES: Everything we do is about caring for our patients, our members, our students, our Geisinger family and our communities.
KINDNESS: We strive to treat everyone as we would hope to be treated ourselves.
EXCELLENCE: We treasure colleagues who humbly strive for excellence.
LEARNING: We share our knowledge with the best and brightest to better prepare the caregivers for tomorrow.
INNOVATION: We constantly seek new and better ways to care for our patients, our members, our community, and the nation.
SAFETY: We provide a safe environment for our patients and members and the Geisinger family.
We offer healthcare benefits for full time and part time positions from day one, including vision, dental and domestic partners. Perhaps just as important, we encourage an atmosphere of collaboration, cooperation and collegiality.
We know that a diverse workforce with unique experiences and backgrounds makes our team stronger. Our patients, members and community come from a wide variety of backgrounds, and it takes a diverse workforce to make better health easier for all. We are proud to be an affirmative action, equal opportunity employer and all qualified applicants will receive consideration for employment regardless to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
Auto-ApplyDirector, Clinical Research Scientist
Clinical research coordinator job in New York
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 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.