Director of Research & Clinical Trials
Clinical research associate job in Jersey City, NJ
Step into a high-impact leadership role at a nationally affiliated cancer center driving innovation in oncology research. MD Anderson Cancer Center at Cooper seeks a Medical Oncologist to serve as Director of Research & Clinical Trials, expanding an established program and launching a new Phase 1 site. Collaborate with MD Anderson-Houston and cross-disciplinary partners. Connect with us today to learn more.
Opportunity Highlights
Step into a leadership role expanding a respected program affiliated with MD Anderson, the nation's No. 1 cancer center (US News)
Establish and oversee a dedicated Phase 1 clinical trials program with full-site infrastructure
Drive strategic growth of the clinical trials program as Director of Research & Clinical Trials
Strengthen collaboration with MD Anderson Cancer Center in Houston on joint research initiatives
Build strong partnerships with pharmaceutical sponsors and internal multidisciplinary teams
Advance groundbreaking cancer research through leadership in early-phase and translational trials
Collaborate with surgical oncology to align research goals with clinical care delivery
Engage with the Camden Cancer Research Collaborative to support shared translational initiatives
Enhance cross-disciplinary research by fostering collaboration in both clinical and academic settings
Community Information
Camden, New Jersey, sits on the Delaware River directly across from Philadelphia, offering quick urban access while benefiting from a cost of living below the national average. The city is undergoing a major revitalization, particularly along the waterfront district, where new housing, restaurants, and nightlife are transforming the area into a vibrant urban hub. For those seeking suburban options, nearby Cherry Hill and Voorhees Township are among the most desirable communities in southern New Jersey.
Camden's median home price is 72% less expensive than the national average (Best Places)
Nearby Cherry Hill, NJ, has an A grade from Niche
Camden is just 5 miles from Philadelphia, with public transportation offering commutes as short as 6 minutes by bus and about 10 minutes by subway
The Camden Waterfront features major attractions, including the Adventure Aquarium and Battleship New Jersey
Revitalization efforts continue to expand housing, restaurants, and entertainment options in Camden's waterfront district
Southern New Jersey and Philadelphia are home to leading public and private schools, universities, and academic centers
Residents enjoy regional scenic beauty and easy access to local wineries, breweries, and the shores of NJ and Delaware
Job Benefits
About the Company
At AMN Healthcare, we strive to be recognized as the most trusted, innovative, and influential force in helping healthcare organizations provide quality patient care that continually evolves to make healthcare more human, more effective, and more achievable.
Internal Medicine, Hematologist Oncologist, Ho, Hematology Oncologist, Oncology, Oncologist, Blood, Blood Illness, Blood Cells, Physician, Md
AMN Healthcare is a digitally enabled workforce solutions partner focused on solving the biggest challenges affecting healthcare organizations today. We offer a single-partner approach to optimize labor sources, increase operating margins, and provide technologies to expand the reach of care.
Clinical Scientist
Clinical research associate 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 Scientist Data Reviewer
Clinical research associate 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 Trial Associate - Consultant
Clinical research associate 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
Administrative Researcher
Clinical research associate 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.
Clinical Research Manager
Clinical research associate 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.)
Clinical Research Associate
Clinical research associate 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
Director, Clinical Research Scientist
Clinical research associate 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 associate 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
Clinical Research Associate
Clinical research associate 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 Associate II
Clinical research associate job in Newark, NJ
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Specialist
Clinical research associate 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 Scientist
Clinical research associate 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 associate job in Jersey City, NJ
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Reporting to the Senior Director, Clinical Development, the 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
Auto-ApplyClinical Research Scientist
Clinical research associate 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.
Regulatory Clinical Scientist
Clinical research associate 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 Scientist
Clinical research associate 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
Responsibilities will include, but are not limited to, the following:
1. Assist the Clinical Research Physician to interface with project team members including: Clinical
Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
4. Clinical study report preparation
5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
6. Participate in Development Planning for assigned compounds.
7. Oversee and challenges the adequacy of planning for study implementation
8. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals
9. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects
10. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety)
11. Collaborates and supports operational activities as need be.
12. Assist in establishing project budgets
13. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
14. Participate and present at investigator meetings
15. Participate in adhoc meetings (e.g. marketing)
16. Assist in document template design and SOP writing
17. Participate on various corporate committees
18. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required
19. Lead team meetings as required
Qualifications
Qualifications
Prerequisite
:
Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field),
Skills/Knowledge Required:
• Minimum 2 yrs. experience in medical or technical writing
• Clinical monitoring experience preferred
• Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization.
• Extensive medical/scientific and clinical research knowledge
• Knowledge of Medical Terminology
• Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics
• Proficient at data interpretation
• Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
• Experience in all aspects of the drug development process
• Knowledge of GCP and ICH Guidelines
• Experience in presenting at Investigator Meetings
• Detail-oriented, well-organized
• Limited travel required
• Ability to assimilate technical and scientific information quickly
• Clinical project management skills
• Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus
• Demonstrated ability to work as part of a team
• High level of interpersonal and communication skills (written and verbal)
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!
Manager, Clinical Research
Clinical research associate job in Paramus, NJ
Job Description
NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan.
Manage and support the execution of assigned global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements.
Essential Duties and Responsibilities:
Assist to plan, implement, manage and report for regional or global clinical studies.
Manage selection process of CROs for regional or global clinical studies.
Manage the performance of study vendors (e.g. CROs and central labs)
Manage activities for clinical site selection, investigator meetings and study initiation.
Oversight of patient recruitment and development of recruitment strategies and plans
Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.)
Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans.
Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols.
Coordinate negotiation of clinical trial contracts between investigational sites and CROs.
Manage assigned vendors to ensure timely analysis output delivery in accordance with vendor-specific plan.
Support coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites.
Implement project specific training program and training materials
Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes.
Perform tasks administrative in nature (e.g. coordination, schedules, submission, filing, etc.).
As needed and required perform other tasks and functions.
Qualifications:
Must be able to manage and coordinate with the Clinical Lead and Study Manager to achieve project objectives and able to manage/solve project management performance issues if they arise.
Demonstrated ability to support the development and management of various aspects of the end to end study operational plan.
Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, Head Office in Japan, external partners and vendors.
Thorough understanding of clinical operations involved as related to the planning, conducting, and closing clinical studies.
Ability to handle multiple tasks and prioritize.
Strong organizational, communication and presentation skills.
Team player, flexible, ability to adapt to change.
Must be able to travel within the US and outside of US 15-25% monthly and interact with Investigators in-person regarding the protocol and study drug.
Education and Experience:
Bachelor's Degree in sciences or related field with a minimum of 3 to 5 years of pharmaceuticals/biotech experience.
Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials.
Program and project management experience preferred.
Compensation And Benefits:
NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.
The annualized target salary range for this role is $110,000 to $135,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.
Other benefits include:
Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
Discretionary Bonus Programs and Long-term Incentive Plan
Retirement Savings 401k with company match
Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown.
Career Development, Progression and Training
Flexible Work Arrangement Programs
Applications will be accepted until January 19, 2025, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma.
NS Pharma is an EEO employer.
Clinical Research Study Manager
Clinical research associate job in Jersey City, NJ
Clinical Research Study Manager A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.
DUTIES & RESPONSIBILITIES
Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.
Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
Adherence and compliance to the assigned protocols at their respective site(s).
Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to
Sponsor-provided and IRB-approved Protocol Training
All relevant Protocol Amendments Training
Any study-specific Manuals Training as applicable
Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.
Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.
Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.
Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.
Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.
Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
Being prepared for and available at all required company meetings.
Submitting required administrative paperwork per company timelines.
Occasionally attending out-of-town Investigator Meetings.
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
Facilitate effective communication between patients, healthcare providers, and research staff
Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
Facilitate effective communication between patients, healthcare providers, and research staff
Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE Education:
High School Diploma or equivalent required
Bachelor's degree preferred
Foreign Medical Graduates preferred
Experience:
Minimum of 5 years experience in Clinical Research
Supervisory experience preferred
Wide therapeutic range of clinical trials experience preferred
Regulatory research experience is a plus
Credentials:
ACRP or equivalent certification is preferred
Knowledge and Skills:
Goals-driven while continuously maintaining quality.
Must be detailed-oriented, proactive, and able to take initiative.
Must have strong written and communication skills.
Must have excellent customer service skills.
Proficient communication and comprehension skills both verbal and written in the English language are required.
Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.
Clinical Research Scientist
Clinical research associate job in Woodcliff Lake, NJ
Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits.
I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization.
Job Description
Description
The incumbent is responsible for, but not limited to the following:
• Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
• Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
• Performs literature search and data analysis to address research questions
• In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
• Assisting in database cleaning, review of study results, and interpretation of results
• Adhering to key performance indicators for clinical study development, conduct, and reporting
• Individual contributor with specialized knowledge
• Presents concepts, facts, and reports and advises on key trends and issues
• Troubleshooting routine site inquiries
• Work is completed under limited supervision
• Supports the planning, execution and reporting of clinical programs/trials
• May handle multiple protocols simultaneously
• Contributes to risk resolution by escalating and monitoring project risks
• Minimum of 5-7 years of experience in 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.