Clinical research associate jobs in Jackson, NJ

Base Salary: $150K USD + Bonus | Full-Time | Remote Globally recognized, publicly traded full-service CRO that's redefining clinical research across continents. With a footprint in over 30 countries and a workforce of 10,000+, this organization partners with thousands of biopharma and medtech innovators to bring cutting-edge therapies to market. From oncology to rare diseases, their pipeline is as diverse as their team. Leveraging AI-powered platforms and real-world data, they're not just conducting trials-they're shaping the future of medicine. If you're a Clinical Project Manager looking to lead global studies in a collaborative, tech-forward environment, this is your chance to thrive. Key Responsibilities Lead and manage global Phase I-IV clinical trials across cardiovascular and oncology indications Oversee cross-functional teams including biometrics, regulatory affairs, medical writing, and pharmacovigilance to ensure seamless trial execution. Develop and maintain project timelines, budgets, and risk mitigation strategies. Serve as the primary point of contact for sponsors, vendors, and internal stakeholders. Ensure compliance with ICH-GCP, FDA, EMA, and local regulatory requirements. Utilize AI-enabled tools and platforms to optimize trial design and operational efficiency. Contribute to business operations including budgeting, forecasting, and resource planning. Mentor junior team members and foster a culture of excellence and innovation. Qualifications Minimum 10 years of experience in clinical research, with at least 6 years as a Clinical Project Manager. Must have direct experience managing both cardiovascular and oncology studies. Experience across multiple phases, preferably Phase II-III. Global trial management experience is essential. CRO experience strongly preferred. Strong understanding of drug development processes and clinical trial regulations. Valid and current GCP certification required. Solid knowledge of local regulatory requirements in the U.S. and/or EU. Proven experience in budgeting and business operations related to clinical project management. Excellent communication, leadership, and problem-solving skills. If you or someone you know fits this experience and shows interest, we'd love to speak with you!

Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management. We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you! Employment Type: Full Time Location: Freehold, NJ Compensation: $27.09 - $36.54 per hour Compensation packages based on your unique skills, experience, and qualifications 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. ESSENTIAL DUTIES AND RESPONSIBILITIES: Demonstrate understanding of the protocol elements and requirements. Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality. Screening, recruit, enroll prospective patients using EMR, EDC, CTMS Create and maintain enrollment logs for each trial from beginning to end Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial. Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial. Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance. Enter all the data to EDC, and EMR within 24 hours of data collection. Communicate and resolve all the data queries within 5-days Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator. Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times. Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements. Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues. Supports internal and external audits Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements. Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions. Conduct clinical trial weekly and monthly meetings within the division. Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings. Track and submit clinical trial patient reimbursement. Other duties as assigned. Requirements Minimum Job Qualifications: Minimum 1 year of experience with oncology interventional clinical trials. ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience. High School diploma with four years of oncology clinical trial experience. Computer literate with good interpersonal, writing, and verbal communication skills. Previous regulatory affairs experience is a plus. Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network. Prior experience working with centrifuge and handling biofluid specimens is preferred. Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure. 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 will be offered 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 will be offered to enable individuals with disabilities to perform the essential functions. 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. Salary Description $27.09 - $36.54

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

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. The Clinical Science Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. * Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team * Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials * Ensures consistency across studies and provide oversight of all clinical studies within assigned area * May serve as a Clinical Trial Lead or Co-Lead as needed * May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities * Serves as a key cross functional collaborator; initial point of escalation cross functions Key Responsibilities * Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical development and lifecycle planning * Lead implementation of assigned clinical development and/or lifecycle plans * Maintain an advanced understanding of all protocols within assigned Program * Provide scientific and clinical leadership to support all activities to advance the assigned plans; Provide program/study/therapeutic area/skills training to team members * Represent Clinical Science Team on the Program Team as appropriate/requested * Support resourcing and budget planning activities for team * Review and present data and information to external investigators and internal stakeholders as needed * Identify and liaise with internal and external collaborators independently and oversee collaboration between clinical scientist and external partners for scientific advice * Lead proactive risk identification and mitigation at indication level; provide progress reports and risk assessment updates to Sr. Management * Author/Review abstracts/publications * Oversee, contribute to, and ensure quality execution of deliverables for all phases of assigned trials (start up/conduct/closure), through activities such as: * Evaluation of innovative trial designs * Protocol and ICF development * Site-facing activities * CRA training materials * Data quality activities; ensure consistent, quality data review across trial teams * Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities * Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses) Qualifications & Experience * Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) Experience Requirements: * 5+ years of experience in clinical science, clinical research, or equivalent * Experience in driving, managing and collaborating in a team/matrix work environment * Recognized internally and externally as a Therapeutic Area and Functional expert * Preferred experience in Neuroscience and/or Psychiatric Key Competency Requirements: * Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations * Ability to plan and manage * Advanced ability to analyze, interpret, and present data * Advanced knowledge and skills to support program specific data review, trend identification, data interpretation * Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements * Advanced medical writing and presentation skills * Ability to self-supervise, and act independently to identify/resolve program level issues * Proficient critical thinking, problem solving, decision making skills * Effective planning and time management * Advanced verbal, written and interpersonal skills (communication skills) * Adaptable and analytical * Strong presentation skills / leadership presence * Commitment to Quality * Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism * Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals) * Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools * Travel Required * Domestic and International travel may be required. Travel Required * Domestic and International travel may be required. The starting compensation for this job is a range from $182,000-$257,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. #li-hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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

Job Description About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit's license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting . Overview of Role: We are seeking an experienced and highly motivated Manager to join our team. This role is crucial in managing site agreements to support our programs. The ideal candidate will have extensive experience in site contract and budget negotiation, as well as managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations. Role and Responsibilities: Under minimal guidance, develop pricing strategies for site budgets to enable contract execution and site activation Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards Negotiate and finalize site agreements, including budgets, contracts, and other necessary documentation. Knowledge of CTA legal risks and possible fallback language required Rigorous analysis of budgets with the goal of securing the best price Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledge of all details Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts Provide regular updates to study management on progress and key performance indicators related to trial agreements Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes Build and maintain strong relationships with CROs, FSP providers, and clinical sites Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations Ensure timely and cost-effective solutions that meet project timelines and budgets Address and resolve any issues or disputes related to site agreements Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development Develop and implement innovative ideas and solutions to increase the efficiency of the department All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree in Life Sciences, Business Administration or related field required A minimum of 4+ years' experience with clinical trial site agreements in biotech or pharmaceutical setting Experience in oncology is highly desirable Strong global negotiation and contract management skills Experience in clinical operations and/or study start up Strong financial acumen and ability to understand and create budgets Experience working with site budgets on a global scale, and potential internal escalation pathway Strong knowledge of using grant plan or similar benchmarking tool Expertise in large, multi-site, clinical trials with multiple vendor types is preferred Direct negotiating with sites and vendors is a must Good understanding of the clinical process is important Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable Strong computer and database skills Attention to detail, accuracy, and confidentiality Clear and concise oral and written communication skills Excellent communication, interpersonal and organizational skills Critical thinking, problem solving, ability to work independently Must be able to effectively multi-task and manage time-sensitive and highly confidential documents Prioritize conflicting demands Work in a fast-paced, demanding, and collaborative environment Knowledge of GCP guidelines and relevant regulatory requirements The pay range for this role is $118,500 - $139,000 per year. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities The Analytical Scientist II is responsible for extracting and analyzing samples according to established procedures and SOPs. JOB RESPONSIBILITIES Perform all activities related to processing and analyzing biological samples. Participate in developing and validating bioanalytical methods. Documents the activities related to sample analysis and assist in verifying various documents. Assist in reviewing bioanalytical and method SOPs. Initiate analysis runs using the appropriate instruments and software. Follows-up on result analysis and assists in finding solutions to bioanalytical issues. Assist with the integration and revision of data using specialized computer applications. Assist in eliminating the chemical and biological waste generated by laboratory employees and helps clean laboratory equipment and instruments. Perform support tasks to meet the needs of laboratory users. Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management. QUALIFICATION Bachelors or College Degree in Science. Good understanding of bioanalytical processes used in the laboratory. Must demonstrate good computer skills especially in the utilization of Microsoft Word, Excel and analytical software. Knowledge of chromatography software. Experience in regulatory context. English level (Quebec specific); required bilingualism includes understanding simple messages and following basic instructions. Relative alternate certification may be considered acceptable. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Clinical Research 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.

Job Description WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. We are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients' mission to impact and save lives. Reasons to work for Vitalief: You can actively contribute to our clients' mission of advancing scientific discoveries that have the potential to change patients' lives for the better. Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. We give everyone a seat at the table - we encourage innovation. Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range: Market competitive - based on experience level. Work Location: New Brunswick, NJ. Four (4) days on-site and one (1) day remote on a weekly basis. Responsibilities: Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Phase 1 Oncology trials. Serves as a liaison (Communicating effectively) between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors - to ensure that services are coordinated and delivered to patients in a timely manner. Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials. Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms. Schedules and conducts trial visits by informing patients and coordinating procedures per protocol. Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol. Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies. Required Skills: Bachelor's Degree required. Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol. Oncology clinical research experience is a huge plus. Phase 1 clinical research experience is a plus. Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines. Compassionate personality and ability to interact with patients in a clear and confident manner. Ability to work on several trials concurrently - can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills. Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner. Needs to be communicative and responsive and know when to escalate and communicate issues to management. Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently. Must have strong Microsoft Office skills. Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR 7Th8KZOkPJ

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $35-$41/h depending on education, experience, and skillset. Essential Responsibilities and Duties: Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Oversees study protocol scheduling and collection of data. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities. Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness. Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator II position. Bachelor's degree, preferred. CCRC certification preferred. 5 years of experience in the medical field or Masters Degree, preferred. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires. Job Description The primary responsibility of the Research Assistant is to assist the Research Unit in conducting clinical trials. The Research Assistant is responsible for collecting and processing clinical data and providing administrative support to the Research Team. Essential Functions * Assists the Research Coordinator with the conduction of clinical trials and patient flow. * Accurately collects clinical data on research patients. Maintains and updates information in data base. * Assists Coordinator with monitor preparation and follows up on any action items and query resolution. * Assists in trial recruitment (chart reviews, communicating with Physicians, database reports). * Aides in regulatory submissions and assists Regulatory Specialist as needed. * Assists Fellows and Physicians on research projects and data collection. * Maintains temperature logs for drug closet, freezer and refrigerator. Reports any deviations. Checks and replaces batteries as needed. * Performs administrative duties for the Research Department including answering phones, scheduling appointments, and ordering supplies. * Telephone screening of patients. * Screens research subjects with Coordinator assistance. * Regular and predictable on-site attendance required. * Works overtime as needed. * Travels to other MAR locations as needed. * Performs other duties as assigned. Supervisory Responsibility This position has no direct supervisory responsibilities. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical and Cognitive Demands The physical and cognitive demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. * This position is very active and requires standing and walking all day in order to get patients and bring them to rooms, assist physicians and rotate assignments with other staff. * While performing the duties of this job, the employee is regularly required to talk, communicate verbally in front of groups, one to one and over the telephone and in email. * Occasional bending, kneeling, stooping, and crouching. * Lift or move objects weighing over 15 pounds as needed. * Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Working environment in exam rooms is often in moderate light. * Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina. * Ability to raise dominant arm above shoulder height to administer drops. * Use senses to observe and examine patients, paying attention to detail. * Works with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying and recording, storing and retrieving information. * Using words to communicate ideas, reading with comprehension, writing reports or other documentation, teaching or training patients. * Sustain physical contact with another person in order to guide them due to their diminished vision. * Ability to follow through on plans or instructions. Travel Willingness to travel is required. Required Education and Experience * 1 year clinical research experience or ophthalmic experience.

Idea Evolver is seeking a forward-thinking AI-Search Coordinator to join our growing team. This is not your typical SEO role-we're looking for someone who understands people and integrates AI into their everyday workflow. As part of our team, you'll explore how audiences discover information across both traditional and emerging AI-driven platforms, translating those insights into strategies that drive content performance and client growth. You'll collaborate closely with leaders in healthcare and other regulated industries to help them adapt to the future of AI-driven digital discovery.What You'll Do Conduct advanced search behavior research using our AI-powered platform, SEMrush, Google Search Console, and other leading tools. Leverage AI to streamline research, surface patterns, and deliver actionable insights faster. Transform search and performance data into clear, compelling stories and recommendations for clients. Support technical SEO best practices to ensure websites meet modern performance, accessibility, and indexability standards. Monitor and interpret performance metrics (via Google Analytics and other platforms), delivering optimization strategies that move the needle. Stay at the forefront of AI-driven search and conversational experiences, helping clients position their content for visibility in these new discovery environments. Deliver client-ready materials-reports, roadmaps, presentations-that drive meaningful business outcomes. What We're Looking For A human who loves what they do and is energized by solving complex problems. A human who wants to contribute to building AI solutions for search and content discovery. 4+ years of experience in SEO, search analytics, or related digital marketing roles. Outstanding communication skills-able to turn complex insights into engaging, client-friendly narratives. Proven ability to collaborate across disciplines in fast-moving, data-driven environments. Experience in healthcare, life sciences, or other regulated industries is a plus. Why Join Idea Evolver Collaborate with a forward-thinking agency at the forefront of AI and search innovation. Partner with high-profile clients in healthcare and consumer industries. Be part of a collaborative, growth-oriented culture where your ideas directly influence outcomes. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional development. Ready to help shape the future of AI-powered search? Apply today to join Idea Evolver's AI-Search & Analytics team and lead the charge into the next era of digital discovery.

We are seeking a skilled Clinical Research Coordinator with strong experience in clinical research to support a research site involved in an oncology trial. The candidate is expected to be onsite 2-3 days a week. Responsibilities + Collect and enter data into the Electronic Data Capture (EDC) system. + Resolve queries related to clinical trial data. Essential Skills + Experience as a Clinical Research Coordinator. + Minimum of 2 years of experience in EDC data entry. + Training in HIPAA & GCP. + Experience in oncology. Work Environment The position operates during normal business hours in a fast-paced environment where attention to detail is crucial. Job Type & Location This is a Contract position based out of New Brunswick, NJ. Pay and Benefits The pay range for this position is $25.00 - $30.00/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 fully onsite position in New Brunswick,NJ. Application Deadline This position is anticipated to close on Dec 23, 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.

About the Role The Clinical Research Assistant (CRA) is responsible for helping to conduct and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. What You'll Be Doing Administratively and clinically help coordinate with a team to work on a minimum of six clinical trials (level 1-3 clinical research protocol) . Help schedule, plan and participate in study monitoring visits and address any potential queries or deviations in accordance to the study protocol. Acts as a liaison between sponsor and the research department. In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria. Acts as a study resource for patients and family. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation. Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction. Dispenses study medications in accordance to protocol requirements within his/her scope of practice. Performs Investigational Product accountability for accurate compliance. Collects, processes and ships blood/urine specimens at scheduled times. Contacts outside health care providers and communicates with subjects to obtain follow up information. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Ensures filing and maintenance of all regulatory documents. Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. Maintains required continuing education hours required for certifications. Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). Maintains a high level of patient confidentiality. Performs all other duties as assigned. What We Expect from You Associates or Bachelor's Degree from an accredited college or university. Good Clinical Practice (GCP) Certificate International Air Transport Association (IATA) Certificate CCRC certification through an accredited organization (ACRP/SoCRA) is required 2-3 years related Research experience Preferred. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems. Physical Demands 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. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Travel Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected. Salary Range $15 - 20 per hour The compensation range listed reflects the anticipated base pay for this position. Actual compensation will be determined based on factors such as relevant experience, education, skills, and work location. What We are Offer You At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters” Compassion Make Someone's Day Collaboration Achieve Possibilities Together Respect Treat people with dignity Accountability Do the right thing Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more. About US Urology Partners U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy. U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description The Clinical Research Associate for Clinical Operation will provide site monitoring and management oversight across multiple clinical research trials in support of development of Pharmaceutical's drug pipeline. This position will report to Associate Director of Clinical Operations and be responsible for operational support for clinical studies and related activities in accordance with company standard operating procedures, good clinical practice, and applicable regulatory requirements. JOB RESPONSIBILITIES: Support project management oversight of Clinical Development activities for multiple domestic and international trials, including: Track study timelines; Review and track study budgets; Provide periodic updates on Clinical Development Gradually develop responsibilities for management of contract research organization (CROs) activities for clinical and data management Provide monitoring support, in some cases functioning as the primary site monitor. Assist in writing and review of protocols, amendments, and informed consent forms. Manage development of study-specific guidelines (Case Report Forms, Monitoring Plans, and Pharmacy Manuals, etc.) Collaborate with Quality Assurance Department in development of Clinical Development standard operating procedures (SOP). Perform investigative site training Review CRO, vendor, and internal SOPs to ensure consistency and proper delegation of responsibilities among study teams. Assist in development of vendor relationships with CROs, drug depots, country-specific laboratories, and other vendors, as needed. Provide internal support for site recruitment activities. Oversee Trial Master File maintenance and reconciliation. Provide support to Regulatory Department in regulatory activities including submissions, and review of regulatory documents. Ensure compliance with FDA regulations and ICH Good Clinical Practice guidelines, as well as country-specific guidelines. Ensure compliance with study-specific procedures. Ensure compliance with study-specific procedures. KEY CONSIDERATIONS: Collaborate in a cross-functional environment in a small biotechnology company to assist in the initiation and coordination of global clinical initiatives and strategies. A strong background as a clinical research associate (CRA), specifically site monitoring or, alternatively; a nursing background would be noteworthy, particularly if the candidate has worked as a nurse at a research site. A therapeutic background to complement our pipeline, i.e. Cardiovascular, Hematology, Oncology, Pulmonology. Well-versed in Good Clinical Practices, medical terminology, and standard study procedures. Experience with electronic data capture systems. Good quality background and experience with healthcare or pharmaceutical development is required. Must be driven to deliver quality results on time and in a highly ethical and professional manner; Candidate must be willing to travel internationally (up to 25-50%, potential more depending on enrollment). Great organizational and communication skills. Proficient in use of Microsoft Office applications. Qualifications Thorough knowledge of Good Clinical Practice, clinical trial design, regulatory processes, and global clinical development process. 3-5 years of investigative site monitoring or study coordinator/study nurse experience. Hands-on experience in data cleaning and analysis required. Proven ability to work independently, to lead a multidisciplinary trial team. Proven experience in developing effective relationships with key investigators. Ability to maintain effective working relationships with coworkers, managers, as well as investigative site personnel. EDUCATION: Undergraduate Degree Additional Information Kind Regards Kavita Kumari Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I Direct Line : 732-549-5302 Ext 208 www.irionline.com

This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires. Job Description The primary responsibility of the Research Assistant is to assist the Research Unit in conducting clinical trials. The Research Assistant is responsible for collecting and processing clinical data and providing administrative support to the Research Team. Essential Functions Assists the Research Coordinator with the conduction of clinical trials and patient flow. Accurately collects clinical data on research patients. Maintains and updates information in data base. Assists Coordinator with monitor preparation and follows up on any action items and query resolution. Assists in trial recruitment (chart reviews, communicating with Physicians, database reports). Aides in regulatory submissions and assists Regulatory Specialist as needed. Assists Fellows and Physicians on research projects and data collection. Maintains temperature logs for drug closet, freezer and refrigerator. Reports any deviations. Checks and replaces batteries as needed. Performs administrative duties for the Research Department including answering phones, scheduling appointments, and ordering supplies. Telephone screening of patients. Screens research subjects with Coordinator assistance. Regular and predictable on-site attendance required. Works overtime as needed. Travels to other MAR locations as needed. Performs other duties as assigned. Supervisory Responsibility This position has no direct supervisory responsibilities. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical and Cognitive Demands The physical and cognitive demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. This position is very active and requires standing and walking all day in order to get patients and bring them to rooms, assist physicians and rotate assignments with other staff. While performing the duties of this job, the employee is regularly required to talk, communicate verbally in front of groups, one to one and over the telephone and in email. Occasional bending, kneeling, stooping, and crouching. Lift or move objects weighing over 15 pounds as needed. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Working environment in exam rooms is often in moderate light. Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina. Ability to raise dominant arm above shoulder height to administer drops. Use senses to observe and examine patients, paying attention to detail. Works with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying and recording, storing and retrieving information. Using words to communicate ideas, reading with comprehension, writing reports or other documentation, teaching or training patients. Sustain physical contact with another person in order to guide them due to their diminished vision. Ability to follow through on plans or instructions. Travel Willingness to travel is required. Required Education and Experience 1 year clinical research experience or ophthalmic experience. Job Posted by ApplicantPro

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation of $28-33/h, and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $28-33/h depending on experience, education and skillset Essential Responsibilities and Duties: Assists with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelors Degree, preferred. 0-3 years of experience in the medical field. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Job Description WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. Reasons to Work for Vitalief: Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. We give everyone a seat at the table - we encourage innovation. We're committed to our employees - you are encouraged and mentored by the talented Vitalief team to achieve full potential. “Life/Work” balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range: $60,000 to $70,000 annually Work Location: Work is 5 days per week on-site in New Brunswick, NJ. Job Responsibilities: Under the direct supervision of the Nurse Manager of Clinical Research Center (CRC), you will be responsible for performing a wide variety of tasks to ensure successful Oncology related clinical trials. Manage eligibility check lists, perform patient screening/consenting (informed consent), patient activation and managing patient care (patient retention). Assist with monitoring patient visits. Track deviations and documenting SAEs (serious adverse events). Ship specimens to central labs or research labs. Track data queries and prepare data for an upcoming audit. Work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner. Required Skills: Minimum of 1 to 2 years of experience in Clinical Research as a Clinical Research Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance and data management. Bachelor's Degree required. Any experience in Oncology and/or working on complex clinical trials is a plus. Ability to work on 12 to 15 concurrent trials - must have strong organizational and prioritization skills. The keys to success in this role are your ability to demonstrate your versatility, “can do” attitude, and adaptability. Considerable understanding of Good Clinical Practice (GCP) guidelines. Experience in preparation of documents for submission to the Institutional Review Board (IRB), continuing reviews, and submission of amendments and modifications. Experience ensuring Serious Adverse Events (SAEs) are completed and reported to the QA Manager and sponsor, if necessary, within reporting deadlines outlined in the protocol. Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus. PHYSICAL DEMANDS: Standing, sitting, walking, talking, hearing, and visual perception. Lifting up to 25lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that requires all on-site resources such as prospective Vitalief consultants to provide proof that they are fully vaccinated for Covid-19; inoculated annually for Influenza; and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR GBWfqAmqbc

We are seeking a skilled Clinical Research Coordinator with strong experience in clinical research to support a research site involved in an oncology trial. The candidate is expected to be onsite 2-3 days a week. Responsibilities * Collect and enter data into the Electronic Data Capture (EDC) system. * Resolve queries related to clinical trial data. Essential Skills * Experience as a Clinical Research Coordinator. * Minimum of 2 years of experience in EDC data entry. * Training in HIPAA & GCP. * Experience in oncology. Work Environment The position operates during normal business hours in a fast-paced environment where attention to detail is crucial. Job Type & Location This is a Contract position based out of New Brunswick, NJ. Pay and Benefits The pay range for this position is $25.00 - $30.00/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 fully onsite position in New Brunswick,NJ. Application Deadline This position is anticipated to close on Dec 23, 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.