Clinical research associate jobs in Ramapo, NY

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 • 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 • Minimum of college degree in a relevant discipline. • Bachelor's degree in relevant scientific discipline preferred. Additional Information For more information, please contact Akriti Gupta ************** Ext.3409 Morristown, NJ 07960

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Clinical Research Associate 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

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 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team. Responsibilities Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols. Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team. Ensure compliance with the Good Clinical Practice guidelines in clinical research. Monitor study patients for adverse events in collaboration with clinical team and report as required. Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements. Qualifications Education requirement: BS Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments. Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.

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.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and comply with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities * Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. * Demonstrate compliance with procedures and be accountable for compliance of team members. * Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. * Supervise and participate in medical monitoring activities, including data review, safety assessments, and protocol deviation management. * Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. * Collaborate with Global Patient Safety on risk management planning. * Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. * Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. * Participate in data analysis, scientific dissemination, and preparation of final study reports. * Analyze and contextualize clinical data to support decision-making and portfolio strategy. * Contribute to strategic planning and innovation through cross-functional working groups. * Support planning and execution of symposia, advisory boards, and other external engagements. * Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. * Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development * Stay current with medical literature and scientific developments in breast oncology. * Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. * Provide scientific consultation to medical affairs, health outcomes, and commercial teams. * Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development * Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. * Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: * PhD with 3+ years of industry experience) OR (BS Degree or equivalent experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Direct Line Leadership experience Additional Information/Preferences: * Breast cancer disease state knowledge/experience * An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) * Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. * Proven strong communication, interpersonal, teamwork, organizational, and negotiation skills * Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. * Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. * Fluent in English, verbal and written communication Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

As a Clinical Trial Specialist, you will coordinate the initiation and activation of new clinical trial protocols. This role involves verifying necessary approvals from various boards and committees, preparing study tools, and ensuring that all patient documentation is accurate and complete. You will work closely with Research Nurse Clinicians and physicians to confirm protocol eligibility and maintain comprehensive research records. Responsibilities + Coordinate the initiation and activation of all new clinical trial protocols, ensuring all necessary approvals are obtained before study activation. + Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets. + Develop study tools using software like Excel and Word , and review patients' charts to confirm protocol eligibility. + Ensure informed consent forms are obtained, signed, and properly filed in the medical records. + Register consented research patients with the study sponsor and input data into the clinical trials database. + Maintain research records, including patient consent, eligibility, Case Report Forms (CRFs), registration confirmation, and corresponding source documents. + Assist with grading adverse events using National Cancer Institute criteria or protocol-specific grading scales. + Complete Serious/Unexpected Adverse Event (SAE) forms as required by study sponsors, federal requirements, and institutional guidelines. + Provide regular reports to tumor study group members and the Principal Investigator on assigned studies. + Serve as a study liaison with study sponsors, scheduling monitoring visits and conference calls, and responding to sponsors' queries. Essential Skills + Clinical Research Coordination + Experience in Oncology + Informed Consent Processes + Patient Recruitment and Enrollment + Experience with Source Documents + 2-3 years of clinical research coordinator experience Additional Skills & Qualifications + Bachelor's Degree + Solid knowledge of computer software programs such as Excel , Word , and Access + Detail-oriented with excellent organizational, communication, and interpersonal skills + Ability to maximize resources and seek personal and professional responsibility Job Type & Location This is a Contract to Hire position based out of Newark, NJ. Pay and Benefits The pay range for this position is $35.00 - $38.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Newark,NJ. Application Deadline This position is anticipated to close on Dec 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Patient Coordination Prescreen study candidates Obtain informed consent per Care Access Research SOP. Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines. Assist regulatory personnel with completion and filing of regulatory documents. Assist in the creation and review of source documents. Patient Recruitment Assist with planning and creation of appropriate recruitment materials. Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Other Responsibilities Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct. Communicate clearly verbally and in writing. Attend Investigator meetings as required. Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management Maintain effective relationships with study participants and other care Access Research personnel. The Expertise Required Ability to understand and follow institutional SOPs. Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 1-year prior Clinical Research Coordinator experience required Recent phlebotomy experience required How We Work Together Location: Position requires onsite work 5 days per week at the Yonkers, NY or Hoboken, NJ clinic. Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives. Physical demands associated with this position Include: Walking-20% Standing-20% Sitting-20% Lifting-20% Up to 25lbs Overhead Driving-20% The expected salary range for this role is $55,000-$85,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Benefits & Perks Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Job Details New Jersey City - Jersey City, NJ $64000.00 - $80000.00 Salary/year Clinical Research Coordinator I The Clinical Research Coordinator I will work at site to help ensure that quality research is conducted at the 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. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure 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 Certification on a timely basis. 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. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. 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 a plus Foreign Medical Graduates preferred Experience: 1+ years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. 2+ years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. 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.

The Clinical Research Coordinator III will 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. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure 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 Certification on a timely basis. 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. Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Ability to train and mentor site staff, as needed Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Maintaining a working knowledge of Study Participants' Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team. Maintaining a 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) Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Striving to meet Sponsor subject enrollment goals for their assigned protocols at 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 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. Bilingual in Spanish is a plus

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

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 3+ years of clinical research experience 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

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.

As a Clinical Trial Specialist, you will coordinate the initiation and activation of new clinical trial protocols. This role involves verifying necessary approvals from various boards and committees, preparing study tools, and ensuring that all patient documentation is accurate and complete. You will work closely with Research Nurse Clinicians and physicians to confirm protocol eligibility and maintain comprehensive research records. Responsibilities * Coordinate the initiation and activation of all new clinical trial protocols, ensuring all necessary approvals are obtained before study activation. * Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets. * Develop study tools using software like Excel and Word, and review patients' charts to confirm protocol eligibility. * Ensure informed consent forms are obtained, signed, and properly filed in the medical records. * Register consented research patients with the study sponsor and input data into the clinical trials database. * Maintain research records, including patient consent, eligibility, Case Report Forms (CRFs), registration confirmation, and corresponding source documents. * Assist with grading adverse events using National Cancer Institute criteria or protocol-specific grading scales. * Complete Serious/Unexpected Adverse Event (SAE) forms as required by study sponsors, federal requirements, and institutional guidelines. * Provide regular reports to tumor study group members and the Principal Investigator on assigned studies. * Serve as a study liaison with study sponsors, scheduling monitoring visits and conference calls, and responding to sponsors' queries. Essential Skills * Clinical Research Coordination * Experience in Oncology * Informed Consent Processes * Patient Recruitment and Enrollment * Experience with Source Documents * 2-3 years of clinical research coordinator experience Additional Skills & Qualifications * Bachelor's Degree * Solid knowledge of computer software programs such as Excel, Word, and Access * Detail-oriented with excellent organizational, communication, and interpersonal skills * Ability to maximize resources and seek personal and professional responsibility Job Type & Location This is a Contract to Hire position based out of Newark, NJ. Pay and Benefits The pay range for this position is $35.00 - $38.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Newark,NJ. Application Deadline This position is anticipated to close on Dec 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prescreen study candidates * Obtain informed consent per Care Access Research SOP. * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines. * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Other Responsibilities * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct. * Communicate clearly verbally and in writing. * Attend Investigator meetings as required. * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management * Maintain effective relationships with study participants and other care Access Research personnel. The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 1-year prior Clinical Research Coordinator experience required * Recent phlebotomy experience required How We Work Together * Location: Position requires onsite work 5 days per week at the Yonkers, NY or Hoboken, NJ clinic. * Travel: This role requires up to 10% travel within 100 miles of site. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Physical demands associated with this position Include: * Walking-20% * Standing-20% * Sitting-20% * Lifting-20% * Up to 25lbs Overhead * Driving-20% The expected salary range for this role is $55,000-$85,000 USD per year. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Benefits & Perks * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

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 Trial Assistant We are seeking a motivated and detail-oriented Clinical Trial Assistant. This role involves supporting clinical trials and working within Veeva Vault. Oncology background preferred Essential Skills + 1-2 years of clinical research coordinator experience. + Strong knowledge of clinical research, oncology, and informed consent processes. + Proficiency in software programs such as Excel , Word , and Access . + Excellent organizational, communication, and interpersonal skills. Additional Skills & Qualifications + Bachelor's Degree required. + Experience in screening patients and coordinating study activities. + Comfortable communicating with patients and staff + Detail-oriented and resourceful with a commitment to professional excellence. Job Type & Location This is a Contract to Hire position based out of Newark, NJ. Pay and Benefits The pay range for this position is $30.00 - $33.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Newark,NJ. Application Deadline This position is anticipated to close on Dec 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.