Clinical Research Associate Jobs in Hamilton, NJ

Clinical Supply Project Manager Department: Project Management Reports To: Director, Project Management Classification: Full time FLSA Status: Exempt SUMMARY/OBJECTIVE: Under minimal supervision, the incumbent is responsible for the project management of assigned clients including but not limited to the planning of project resources, assembling, or leading the project team, time management, budget, scope, quality and satisfaction, risk management, monitoring progress, documentation, and reporting. ESSENTIAL DUTIES AND RESPONSIBILITIES: Management of project related activities from definition to launch stage to ensure that projects are delivered on-time, within approved budget and achieves project objectives. Organize and lead project core team meetings. Maintains effective communication and working relationships among project core team. Ability to translate clinical trial synopsis / clinical trial protocol into an efficient and cost-effective plan including, but not limited to: Material Management Manufacturing, Packaging & Labeling - Prepare documents such as, but not limited to, material specifications and batch records. Prepare required distribution documentation, enter & monitor shipments. Prepare required Returns, Accountability and Destruction documentation. Manage all project related inventory to avoid stock out scenarios. Work with cross-functional team members to assess feasibility of project scope and objectives and develop detailed project timeline to ensure that there is enough flexibility and contingency in the plan to respond to unanticipated difficulties. Define and assign schedules and track cross-functional tasks/activities to ensure that project progress within expected timings. Management of monthly project invoicing. Identify, monitor, communicate and resolve issues, scope changes, budget variances or other project objective hurdles that may arise during the project execution. Interface with all functional areas of the business to ensure timely, effective, and efficient execution of project tasks. Lead risk analysis & mitigation planning for projects. Prepare and present project progress reports and presentations as required. Carries out duties in compliance with all federal and state regulations and guidelines. Complies with all company and site policies and procedures including but not limited to safety, standard operating procedures, and work instructions. Remains current in profession and industry trends. Makes a positive contribution as demonstrated by: making suggestions for improvement learning new skills, procedures, and processes. Is available for other duties as required. QUALIFICATIONS AND EXPERIENCE: Bachelor's Degree preferred. Three (3) years of project management experience in packaging, labeling and clinical supply chain as Project Manager or Project Coordinator; or six (6) years of project management experience in packaging, labeling and clinical supply chain as a Project Manager or Project Coordinator. Commercial packaging experience a plus. COMPETENCIES/SKILLS: Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications. Legible Handwriting Communicate clearly in writing and orally. Demonstrate practical knowledge of 21 CFR 210, 21 CFR 211, 21 CFR Part 11, Eudralex Volume 4, and Annex 13. Demonstrate effective collaboration and teamwork. Demonstrate experience managing contract pharmaceutical projects on time and on budget. Demonstrate experience working in a cGxP environment. Familiar with project management tools and technologies such as Microsoft Project. Knowledge of various project management methodologies. Successfully completes regulatory and job training requirements. Computer skills: Enter data into computer using software applications for data entry and word processing. Work and be proficient with e-mail systems. Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production. Ability to work with others in a team environment. SUPERVISORY RESPONSIBILITIES: None WORK ENVIRONMENT: Standard office environment PHYSICAL DEMANDS: Office Environment (standing and sitting) requiring minimal physical exertion. TRAVEL: Domestic travel will be required less than 5% of the time. If you're interested in this position, please email *************************** with your resume and any relevant documentation, including proof of certifications if specified in the . Be sure to include the position title in the subject line of your email. We look forward to connecting with you! The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment. EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

We are looking to add a full time Senior Clinical Research Coordinator to a growing team. This role is hybrid with a WFH option of 2 days per week. The ideal candidate is local to Philadelphia and will be interested in moving into a leadership or project manager type position down the road. This position is working directly with patients, managing the study process from start up through close out on a growing team working to help change the future of therapeutics. Overview The Clinical Research Coordinator (CRC) is responsible for overseeing the day-to-day operations of clinical research trials designed to test the safety and effectiveness of new drugs. The CRC plans and directs clinical research studies - working directly with patients to guide them successfully through the clinical trial process. Duties The CRC thoroughly understands all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator. Communicates closely with the sponsor's Clinical Research Associate (CRA) to facilitate the sponsor monitoring and data maintenance process. The Clinical Research Coordinator completes all monitor and sponsor queries in a timely manner. Track enrollment status of patients and ensure timely communication with patients regarding their study participation. Assess eligibility of potential patients and oversee patient enrollment to ensure that informed consent is properly obtained and documented. Coordinates and conducts patient visits (drawing blood, collecting vital signs, performing ECGs, and processing specimens). Keeps all source documentation up-to-date

The successful candidate will join the team of Dr. Grace Chan at Children's Hospital of Philadelphia. The Chan Lab is dedicated to advancing the survival and health of mothers, newborns, and children. Our research focuses on improving health outcomes in low-resource settings, particularly in the prevention and management of preterm and small babies, neonatal infections, and optimizing growth and development. The primary goal of our research program is to design, test, and scale interventions that prevent morbidity and early mortality among mothers and children worldwide. The Clinical Research Program Manager II at the Chan Lab is responsible for overseeing and managing a diverse portfolio of clinical and population health research projects aimed at improving health outcomes for mothers, newborns, and children, particularly in low-resource settings. This role involves managing multi-country clinical trials, epidemiologic studies, and collaborations with global partners; ensuring compliance with regulatory standards; and providing leadership and mentorship to research staff. It is anticipated that the CRPM will make multiple trips to Ethiopia to oversee the conduct of a clinical trial and meet with collaborators. The CRPM will be responsible for grant writing, financial management, and the preparation of reports for various stakeholders and should have experience in these areas. The ideal candidate will also have outstanding communication and relationship skills and experience with international public health research, project and program administration, and staff supervision. Additionally, the ability to be agile, assess the environment, and develop new programs is essential. The CRPM must also support and lead existing programs in reporting outcomes and activities in collaboration with key global health stakeholders. The expected breakdown of responsibilities would be as follows: 40% grant writing 40% program management (including clinical trial) 10% publication support (contributing to writing, submissions, coordinating co-authors) 10% communications - CHOP and external What you will do Direct and indirect supervision, training, support, and management of staff to ensure compliance with study protocol, NIH and FDA policies. Work collaboratively and effectively with the individual study management teams, various core groups at CHOP's Research Institute and other participating institutions. As part of Management Team, develop, review, and update program policies and procedures as needed. Serve as primary liaison between research and other hospital staff to carry out the needs of the research project(s). Assist with analysis of data and preparation of manuscripts and scientific presentations, as needed. Track regulatory compliance of CHOP and other sites. Oversee clinical trial budget preparations and billing plans and resolution of billing/budget issues. Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials. Provide supervision and support for other clinical research coordinators and or/ monitors who are assigned to specific protocols and who will help with the overall clinical research of the program. Provides a leadership role in developing, implementing, and evaluating the conduct of clinical research Responsible for Regulatory compliance for clinical research program. Critically evaluate decisions on staffing, finances, and regulatory needs for the study lifecycle. Additional responsibilities may include: Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports. Primary contact for trial for internal and external participants. Education Qualifications Bachelor's Degree Required Master's Degree in a related field Preferred Experience Qualifications At least eight (8) years of relevant & complex research experience - Required At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management - Required At least three (3) years of leadership, management or supervisory experience - Required At least ten (10) years of relevant & complex research experience - Preferred At least five (5) years of research administration or management experience, including budget administration, financial planning, and grants management - Preferred At least five (5) years of leadership, management or supervisory experience in a clinical research or academic environment - Preferred Skills and Abilities Excellent verbal and written communications skills Excellent interpersonal skills Excellent customer service skills Excellent time management skills Strong critical thinking / problem-solving skills Excellent project management skills Excellent organizational skills Excellent analytical skills Strong leadership skills Ability to maintain confidentiality and professionalism Ability to work independently with minimal supervision Ability to convey complex or technical information in an easy-to-understand manner Ability to collaborate with stakeholders at all levels Ability to be flexible and adaptable to change

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

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

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple trials within Oncology + Quality of life focus wtih Regional Travel + Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes - Mentors/coaches junior flex team + Acts as Lead SM-training other SMs on study + Develops site start up documents for studies including SIV agenda + Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines) + Represents LTMs or SMs on SMTs/meetings + Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial + Supports country budget development and/or contract negotiation in liaison with CCS colleagues + Assists with ASV + Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces - Primary/Other: + Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. + Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) **You Are:** + B.S., R.N., or equivalent degree, preferably in Biological Sciences + Located in Chicago near a major airport + Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials + Have a minimum of 1-3 years' experience monitoring Oncology trials + Knowledge of several therapeutic areas + Analytical/risk-based monitoring experience is an asset + Ability to actively drive patient recruitment strategies at assigned sites + Ability to partner closely with investigator and site staff to meet all of our study timelines + Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). + Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. + Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. + Need to travel up to 50% + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs + Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead + Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Lead Clinical Research Associate needs: BS/BA, MS is desirable 5+ years of site management of which a minimum of 2 years field monitoring experience Knowledge of applicable standards and regulations for clinical trial Experience in Cardiovascular Therapeutic area IVD Stud Experience Medidata RAVE system Lead Clinical Research Associate duties: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: Implementation of enrollment and recruitment strategies Assistance in vendors' selection processes • Additional Information $45/hr 12 months

Who We Are Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. What You'll Do Our team is growing! At Theradex, you aren't just a number. You are part of a highly engaged team of exceptional and supportive people who pride themselves on quality monitoring, continuous learning, challenge themselves and who reap the rewards of providing first in class monitoring to our sponsors. The primary responsibilities of this position include, but are not limited to, the following: Act as the routine liaison between study site and the project team for study related issues. Ensures protection of subjects, subjects' rights, and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance. Conducts pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs and the specific project scope of work to include but not limited to: Source document review and comparison to CRF data CRF review/retrieval and data corrections IMP accountability Maintenance of on-site investigator files IEC/IRB documentation Local laboratory documentation Maintenance of investigational supplies Reviews consent process for each subject (Informed Consent Form and source documentation) Verify patient eligibility Assess protocol compliance and deviations Handling of safety and efficacy issues, including, but not limited to: Serious adverse event reports Adverse event trends Treatment failures/outcomes Conducts and documents onsite visits/contacts, including: Pre-study visits Initiation visits Routine visits Study completion visits/ Close-out visits Telephone contact Site visit report preparation within study specific timeframe Responsible for all aspects of site management as described in the study plans Proactively identify and resolve issues and potential site and study issues. Assist with regulatory and study start-up activities including contract and budget negotiations, as required. Ensure clinical data integrity and meet study timelines. Provide ongoing updates and support to project management. Mentor junior members of the team. Prepare and deliver staff training sessions. Clinical Review of individual patient listings Initial clinical review of comprehensive patient data listings Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars Assist in the day to day running of projects assigned. Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc. Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc. Maintain current knowledge related to cancer therapy, clinical trial design and conduct, and good clinical practice through literature reviews and other educational opportunities. Perform other duties as assigned by management What You Need Level of Education At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience Prior Experience At least 2 years' experience as a Clinical Research Associate with a sound track record in managing clinical trial sites Experience in monitoring oncology phase I-III studies is preferred Skills and Competencies Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements. Demonstrable multitasking and execution skills. Good interpersonal skills, including communication, presentation, persuasion, and influence. Good organizational skills, including efficiency, punctuality, and collaboration in a team environment. Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and effective in developing solutions to those problems Effective knowledge of the drug development process and the Theradex organizational structure Good communication skills: verbal and written Proficient knowledge of Outlook, Word, Excel and PowerPoint; able to utilize remote meeting/teleconferencing platforms (such as Teams, Zoom, WebEx, GoToMeeting) effectively. Additional Requirements This position involves travel as needed to meet study requirements. Ability to travel up to 50% may involve overnight stays. Valid Driver's License required and Passport preferable. Successfully pass background clearance checks which may be run on a periodic basis due to 3 rd party contractual obligation requirements. Fluent in English (written and verbal) What we offer We offer a supportive culture that puts people first. We provide a competitive compensation, and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more. Theradex is not accepting assistance from search firms for this employment opportunity.

Legend Biotech is seeking an Expert Clinical Research Scientist as part of the Clinical Development team based in Somerset, NJ. The Clinical Research Scientist (CS) in Clinical Development is an important role in the company supporting the development and life cycle of drug development projects. The Clinical Research Scientist will work closely with the Clinical Trial Lead/Medical Lead and Clinical Operations Lead to design and implement clinical trial protocols and manage sites, CROs and other associated work. In addition, the CS will support their manager to ensure program consistency & alignment across studies, working closely with cross-functional teams for achieving project goals, within timelines & with high quality. At the expert clinical research scientist level, the scientist will be expected to perform with less oversight and with higher impact across the assigned program and the organization as compared to the senior clinical research scientist. Key Responsibilities Responsible to ensure the data review and cleaning activities meet the quality standards to support database locks in collaboration with data management and medical leads. Uses clinical and disease state knowledge to develop methods and strategy for data cleaning approach Collaborate with other functions to successfully support the planning and execution of clinical studies. Provides independent leadership of all areas requiring clinical input with some oversight from the assigned Clinical Trial Lead/Medical Lead and proactively produces innovative and quality solutions for issues the trial faces Provides expert clinical input and strategic decision-making for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, clinical portion of feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions. Contributes to the strategic planning, preparation and review of clinical documents in collaboration with the medical director (Protocol, ICFs, CSR, investigator brochure). Expected to lead certain documents or sections of documents, including incorporation of input from other cross-functional team members. Provides expert clinical input and strategic decision-making for regulatory documents needed for all stages of assigned trial lifecycle (IND documentation, HA briefing books, BLAs, and Orphan Drug Applications) Responsible for clinical portions of key data management/statistical documents, and proactively seeks to harmonize across programs (eg: Case Report Forms, edit checks, data review plan and reports) May be asked to support creation of the Global Clinical Development Plan (CDP) for compounds in clinical development or new clinical entities, working closely with medical lead and other stakeholders and cross functional teams. Lead the planning and execution of external meetings and internal stakeholder meetings in collaboration with medical director (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations. Expected to have a speaking role on key meetings. Represent CS function in cross functional activities and contribute to harmonization between clinical trials and process improvement initiatives. Requirements At least a Bachelor's degree in life science discipline. Bachelor's degree with 6+ years'; or MS with 5+ years'; or PharmD/PhD with 4+ years of pharma experience in clinical development or a related field. CAR-T cell therapy experience is a plus. Good interpersonal & communication skills, including oral, written and interpersonal. Ability to effectively manage conflicts and negotiations while providing impact and influence. Collaborative with the ability to operate across multiple geographies. Good leadership & organizational skills, analytical skills, and presentation skills. Creative problem-solving skills. Strong organizational and project management skill and the ability to multitask. Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project). Oncology Therapeutic Experience preferred. #Li-JR1 #Li-Hybrid Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug-free workplace.

One of our large MedTech clients is looking for a Clinical Research Scientist to join their team for a 12+ month project. This individual will support multiple class 3 device trials. They will develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal supervision, plan for study budgets and collaborate with Clinical Operations to manage the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures. They will partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables and will be responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and core teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOP). This role will entail developing strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders and drafting study reports with minimal supervision for assigned studies to include any annual reports, study close out reports as well as clinical sections for IDE, PMA, 510(k), and other regulatory submissions. We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (****************************************** Og4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (*********************************************************************************************** . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: *************************************************** . Skills and Requirements -Strong experience independently writing protocols -Experience writing informed consents -5+ years of experience within MedTech or Pharma -Experience working cross-functionally with "core teams" -Clinical Operations background -3+ years experience as a Clinical Scientist/Clinical PM -Experience with either BOA, PMA, NDA submissions (FDA approval) -Experience with PMCF plans -MedTech experience (class 3) -Global Trial experience -Clinical Study Report writing null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to ********************.

Job Title: Clinical Research ScientistJob Description This position provides an opportunity for growth and development as an independent investigator in NIH-funded research, enhancing skills in academia. The role involves conducting specific research projects related to stroke and traumatic brain injury recovery, while offering intellectual and technical support to research programs and initiatives. Responsibilities + Conduct specific research projects related to stroke and traumatic brain injury recovery. + Provide intellectual and technical support to research programs and initiatives. + Contribute original scholarly activity, demonstrated by first-author publications. + Collaborate with different Principal Investigators within the institution. Essential Skills + Ph.D. or M.D. in a scientific field. + 2-4 years of experience as a research scientist. + Experience in immunology and flow cytometry. + Background in Cancer Immunology, Biology, Molecular Biology, Clinical Research, and Clinical Development. Additional Skills & Qualifications + Proven scholarly activity in the form of first-author, original publications. + Ability to contribute ideas to research projects, rather than merely following protocols. Work Environment This is an on-site position with a 40-hour work week, under a contract lasting 1.5-2 years. The protocols may change weekly, requiring flexibility for shifts that could occur during the day or night. Pay and Benefits The pay range for this position is $37.00 - $38.50/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 Camden,NJ. Application Deadline This position is anticipated to close on May 27, 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 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. 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.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Qualifications Primary Duties and Responsibilities: Act as project manager on studies as directed by department manager Provide expert insight into hair/skin/nail evaluations and assessments Assist in the conduct of clinical trials as specified by the study protocol under the supervision of designated Principal Investigator and departmental management Record observations, measurements, and test results, as required Provide a professional experience to test subjects, and answer all inquiries, as appropriate Assist in the preparation of test materials, as needed Perform data entry and data review to ensure study quality Adhere to all Standard Operating Procedures to ensure consistency and quality work across CRL Efficiently time manage multiple projects Succinctly communicate day to day project details to both department manager and Principal Investigator Perform department specific procedures as qualified by training and evaluation of proficiency Additional Information Additional information COMPREHENSIVE BENEFITS PACKAGE & COMPENSATION As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. Authorization to work in the United States without Sponsorship is required. Candidates that live within 30 miles of Piscataway, NJ are encouraged to apply. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Qualifications Primary Duties and Responsibilities: Act as project manager on studies as directed by department manager Provide expert insight into hair/skin/nail evaluations and assessments Assist in the conduct of clinical trials as specified by the study protocol under the supervision of designated Principal Investigator and departmental management Record observations, measurements, and test results, as required Provide a professional experience to test subjects, and answer all inquiries, as appropriate Assist in the preparation of test materials, as needed Perform data entry and data review to ensure study quality Adhere to all Standard Operating Procedures to ensure consistency and quality work across CRL Efficiently time manage multiple projects Succinctly communicate day to day project details to both department manager and Principal Investigator Perform department specific procedures as qualified by training and evaluation of proficiency Additional Information Additional information COMPREHENSIVE BENEFITS PACKAGE & COMPENSATION As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. Authorization to work in the United States without Sponsorship is required. Candidates that live within 30 miles of Piscataway, NJ are encouraged to apply. Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.

Clinical Research Coordinator (Recruitment Only) - (16001534) Description The Clinical Research Coordinator, in collaboration with the Clinical Investigators at the Lewis Katz School of Medicine, will be responsible for the planning, implementation, and execution of Clinical Trials in the assigned department. Primary responsibilities include the coordination of study enrollment; oversight of study protocols; and submission of research activities per IRB regulations. The incumbent will establish and maintain databases of subjects; process informed consent paperwork; and ensure study payment is processed and received in a timely fashion. Additional responsibilities include working independently to drive day-to-day research activities; supporting multiple active protocols simultaneously; and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations. Performs other duties as assigned. Required Education and Experience:Bachelor's degree in life science, health professions or related field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills and Abilities:*Demonstrated computer and data entry skills, and proficiency with MS Office Suite software programs.*Demonstrated knowledge of IRB protocols and processes.*Strong written and verbal communication skills.*Strong interpersonal skills, along with the ability to interact with a diverse population of students, faculty, staff, and program participants.*Ability to work independently or as part of a team.*Demonstrated strong attention to detail and ability to adhere to project deadlines.*Ability to travel to off-site locations that may not be accessible via public transportation.*Ability to work evenings/weekends hours as needed. Preferred:*Prior Surgical Department experience. *Experience with eDC database. Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status protected by law.Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and. employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety and can be found at: ********************************** You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Student Faculty CenterJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

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

Data Management: Collect and manage clinical trial data from different sources, like forms and electronic systems. Make sure the data is accurate, complete, and entered on time. Check for errors or mismatches in the data and work with the research team to fix them. Help get the data ready for analysis. Study Documentation: Keep study files organized and up-to-date, following all rules and regulations. Make sure all required documents, like consent forms and approvals, are current and ready for audits. Track important dates and deadlines for the study. Compliance & Quality Control: Review data to make sure it follows study rules and Good Clinical Practice (GCP) guidelines. Help prepare for visits and audits from regulatory agencies. Ensure the study meets all legal, ethical, and privacy standards. Collaboration & Communication: Work with investigators, coordinators, and other team members to support the study. Communicate with outside groups like sponsors, CROs, and regulators to keep data flowing smoothly. Create regular updates on how the study is going, including any issues with the data.

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: Lead Clinical Research Associate Location: Raritan, NJ 08869 Responsibilities: LEAD CLINICAL RESEARCH ASSOCIATE: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: • Implementation of enrollment and recruitment strategies • Assistance in vendors' selection processes • Development, execution, management and compliance assurance of the Monitoring Plan • Review and approve trip reports, track scheduling, report submission metrics, site deviations and action items • Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. • Development of training materials and study tools for site and CRA use • Assistance in formation of the Adjudication Committee including oversight of documentation collection and filing into the Trial Master File Qualifications Qualifications: LEAD CLINICAL RESEARCH ASSOCIATE: • BS/BA, MS is desirable • 5+ years of site management of which a minimum of 2 years field monitoring experience • Knowledge of applicable standards and regulations for clinical trial • Proven oral and written communication skills • Proven planning skills; ability to create and track detailed project plans • Proven interpersonal, leadership, organizational and effective time management skills • Microsoft Office proficiency • Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion • Experience in Cardiovascular Therapeutic area • IVD Stud Experience • Medidata RAVE system Additional Information Kind Regards, Sabanaaz Shaikh Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

span id="spandesc"p style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'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. br//pp style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'b style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Essential Duties And Responsibilities/bbr//pul style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'li style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Participate and assist in design and preparation of protocols and case report forms. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Participate in the evaluation of potential clinical sites according to established criteria of acceptability. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Assist with the maintenance of clinical archive and electronic files. br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Other tasks as assigned. br//li/uldivbr//div/spanbr/span id="spanreq"h3Requirements/h3p style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'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. br//pul style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif; font-size:13. 3333px; letter-spacing:normal; font-weight:400; line-height:1. 43; color:rgb(45, 45, 45); font-style:normal; orphans:2; text-indent:0px; text-transform:none; white-space:normal; widows:2; word-spacing:0px'li style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'BA, BS, RN, BSN or equivalentbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Basic knowledge and adherence to GCPsbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'1-2 years of clinical research experience or equivalent experience or training br//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Strong attention to detailbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Ability to multi-taskbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Unquestionable integrity and highest ethical standardsbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Excellent written and verbal communication skillsbr//lili style='font-family:"Noto Sans", "Helvetica Neue", Helvetica, Arial, sans-serif !important'Self-motivated, assertive, and drivenbr//li/uldivbr//div/spanbr/