Clinical Research Associate Jobs in Willingboro, NJ

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.

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.

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.

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, visit ******************** and follow us on LinkedIn and X (Twitter). Uniquely Differentiated. Rapid. Elegant At Cabaletta, we are driven by the shared mission of developing cures, where a patients' own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We're proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work About the Position The Associate Director / Director, Clinical Scientist will collaborate with cross-functional teams (Clinical, Regulatory, Medical Writing, Translational Sciences, CMC, etc.) on writing clinical study synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and TLF shells; participate in emerging clinical trial data evaluation and interpretation; ensure that assigned studies are conducted according to GCPs and Cabaletta's SOPs; conduct literature searches and reviews, meta-analyses, and publishing data; oversee the review of clinical study entries (clinical trial information and results) for posting to ********************** (clinical trial registry and results database) and assist in preparation of IND/ BLA filing and accelerated/pediatric programs packages. The span of responsibilities is broad and will support several clinical programs depending on their size and complexity. The Clinical Scientist will liaise with various vendors, and study investigators at participating sites. Responsibilities: Support the Medical Director or may serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy program. Assists the Medical Director for clinical input to the clinical development plan (CDP) at all stages of the program. Leads (or supports) development of recommendations on further development strategies to internal committees. Member of the cross-functional clinical trial team for assigned studies. Participate in review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information. Participate in development, maintenance, and review of clinical study documents (e.g., protocols and protocol amendment(s), informed consent documents, case report forms) and other relevant strategic documents. Support activities related to the start-up and execution of new clinical trials. Contribute relevant clinical sections to documents such as the IB, DSUR, CSRs, and for regulatory documents such as INDs/CTAs/ accelerated program/RMAT designations/pediatric study plans, and BLA/MAAs. Responsible for clinical data review and drafting reports and presentations on the various findings of the clinical research, including abstracts, posters, publications. Provide support with the activities related to the execution, monitoring, and reporting of clinical trials. Provides scientific/medical mentorship (or coordinates) to the study team, including the CRO team. Perform regular review of clinical data to ensure that the study is conducted in accordance with the protocol, safety procedures are followed, and efficiency is maintained. Assist with safety review procedures: tracking of safety events, review of new SAEs, and composing/editing adverse event narratives. Assist with managing vendor activities as needed. In collaboration with the Medical Director, identify clinical sites that will participate in trials. Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies. May attend Site Initiation Visits, to present the study design and key aspects of the protocol. Leads the compilation and interpretation of the data for and from safety review committees, collaborating closely with the Medical Director. Qualifications: Bachelor of Science degree from an accredited educational institution. Master's degree or PhD, PharmD/RN or the equivalent degree preferred. Minimum 7 years of experience in clinical drug development within a pharmaceutical/biotech or academic environment Strong knowledge of ICH, GCP, and other relevant regulatory guidelines Solid understanding of T-cell biology and cell & gene therapy Prior experience in cell therapy in pharma/biotech is a plus Experience in writing clinical protocols and performing and summarizing relevant literature reviews Strong communication and interpersonal skills Engaged, hands-on, and goal-oriented mentality in a highly dynamic work environment Ability to flexibly contribute simultaneously to multiple facets of drug development Demonstrated ability to learn new therapeutic areas and technologies Self-motivated, innovative, and critical thinker with strong commitment to follow up on action items Strong organizational, analytical, and problem-solving skills Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs Strong team orientation and passion for continuous self-development Experience in the biotech industry or in a startup industrial setting is preferred. Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://********************/join-our-crew Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans. Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Clinical Research Manager is responsible for all aspects of clinical study operations for assigned Integra LifeSciences clinical projects according to the strategy defined by leadership of Integra's Global Clinical Affairs team. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. • Coordinates clinical operations including: Design, initiation, coordination of clinical trials to support regulatory submissions, as well as post-market clinical trials. In case of CRO managed studies: Leads CRO evaluation and selection process and provides ongoing CRO oversight. • Coordinates the preparation of state-of-the-art study documentation, including: protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required. • Ensures compliance with all applicable regulatory standards related to clinical trials and interactions with physicians. Continues to increase knowledge of medical device development process, ICH-GCP, FDA regulations and any other applicable local/international regulatory requirements. • Assists in updating corporate Standard Operating Procedures (SOPs) to support adherence to company policies and procedures concerning Clinical Affairs, in coordination with Global Clinical Affairs team members. • Responsible for the financial management of the clinical trial program including budget planning, resource allocation preparation of quarterly reports and investigator payments as applicable. • Plans and manages study site activities and provides ongoing updates of site status to management. • Supports data collection, assessment and reporting activities. Works closely with Data Management for the design and execution of appropriate data management practices, including the use of electronic data capture (EDC), and clinical trial management systems (CTMS). • Works collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publications. • Anticipates/identifies potential problems and implements corrective actions on clinical trials. • Participates in quality improvement efforts to increase overall operational efficiency of the clinical operations team. • Interfaces with Global Clinical Affairs, Legal, R&D, Marketing and Sales to ensure that clinical activities are in line with overall strategic goals. • Supports regulatory affairs personnel with clinical sections of regulatory submissions, and study related communication with regulatory agencies. Collects, reviews and tracks regulatory documents when required. • Represents the company at conferences, regulatory meetings, and relevant trade associations. • Accurately completes administrative activities in a timely manner. • Ability to travel 20% of time. Qualifications: Education: Bachelor's Degree in LifeSciences, Pharmaceutical or related Sciences required. Advanced degree (PhD, PharmD, MPH, MBA, ...) is a plus. Experience: Five to seven years' experience in clinical research required, preferably in medical device industry. Proven track record of conducting clinical research studies in a hospital setting, medical device and/or pharmaceutical company, or CRO. Specific competencies: • Strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships. • Detail oriented, excellent organizational and management skills. • Position requires composition ability, data analysis skills, scientific writing and presentation skills • Experience in applied science, leadership skills and ability to merge science with business goals preferred. • Expert in design and development of scientific research protocols, clinical investigational plans, and regulatory strategies. Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials. • Experience in the use of electronic data managements systems. • Experience in collaborations with relevant trade organizations, as well as hospitals and physicians. • Effectively interacts with and collaborates at all levels in the organization, including effective interface at the senior management level. • Must be computer literate with working knowledge of Microsoft Office. • Project management certification or relevant experience is a plus. Additional details: This role is hybrid between Princeton, NJ and remote. Office days are Tuesday, Wednesday and Thursday. Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at *********************** or call us at ************. Integra - Employer Branding from Integra LifeSciences on Vimeo

Job Title Clinical Research Program Manager (CPM) Job Reports To Director of Clinical Operations Other Vaccination against COVID-19 is a prerequisite for employment at CHDI Management. Job Description CHDI is a privately-funded, not-for-profit biomedical research organization devoted to a single disease - Huntington's disease (HD). Our mission is to develop drugs that will slow the progression of HD and provide meaningful clinical benefit to patients. CHDI is a “science first” organization; our foremost consideration is to do the best science as quickly and efficiently as possible. CHDI's Clinical Team oversees a portfolio of projects aimed at understanding the natural progression of HD, developing the best biomarkers and outcome measures for use in clinical trials, finding ways to expedite and improve the execution of clinical trials, paving relevant regulatory pathways, and working with external partners to support their clinical development plans. The team engages a diverse array of partners to help manage this portfolio, including academic institutions, government agencies, contract research organizations (CROs), biotech and pharmaceutical companies. We are seeking a highly motivated and organized individual to assist managing projects in the clinical portfolio (including, but not limited to clinical studies and trials). This detail-oriented, self-starting individual will work closely in a team and with internal colleagues (scientific, legal and financial) and external collaborators (physicians, academic institutions, CROs, and biotech and pharmaceutical companies) on all aspects of CHDI's clinical research and development efforts. Job Responsibilities A Clinical Research Program Manager will be expected to work closely with study teams, Directors and others within CHDI in the following areas: Trial Master File (TMF) lead the Request for Proposal (RFP) process for selecting and contracting with a Trial Master File (TMF) vendor and manage the vendor's performance across multiple studies. work cross-functionally with Clinical Operations, regulatory, CROs, and other third-party vendors to manage eTMF processes throughout the study lifecycle serve as the primary point of contact for TMF-related activities across assigned studies lead the planning, setup, and oversight of the TMF, ensuring timely filing and overall health of the TMF throughout the study collaborate with cross-functional teams and CRO vendors to ensure TMF compliance with CHDI SOPs, GCP, and applicable regulatory requirements oversee regular Quality Control activities, including conducting assessment and evaluating the completeness and accuracy of the TMF in line with the TMF plan. develop and maintain TMF management plans, filing matrices, SOPs, and training materials monitor TMF completeness, timeliness, and quality; generate metrics and reports for internal and external stakeholders. lead or support TMF reconciliation activities between sponsor and CRO vendors lead TMF preparation for audits and regulatory inspections; support inspection readiness efforts and participate in inspection-related activities as the TMF representative provide TMF training and guidance to internal teams and external collaborators identify and implement process improvement initiatives to increase TMF efficiency and compliance work with clinical operations and study management teams to address TMF-related CAPAs manage TMF vendor(s) and eTMF platforms oversee additional vendors and service providers, ensuring their activities align with project goals and compliance requirements develop, manage, and monitor budgets related to CHDI agreements, ensuring financial efficiency, adherence to contract terms, and alignment with overall project objectives. provide regular financial reports and address any budgetary variances and drive contract amendments as needed work closely with clinical operations, finance, legal, and other departments to ensure cohesive management of vendor activities. serve as the primary point of contact between vendors and internal teams, facilitating communication and resolving any cross-functional challenges develop and maintain detailed project plans for all vendor management activities, including timelines, milestones, and deliverables. provide regular updates to senior leadership, highlighting key achievements, risks, and issues continuously assess and enhance vendor management processes, incorporating lessons learned and industry best practices to improve efficiency and effectiveness develop and review project descriptions, project budgets and associated contracts (e.g., funding, CROs, etc.) to assure compliance with Foundation policies. Clinical study management manage and drive various aspects of select clinical studies and process improvement projects proactively identify issues and facilitate discussion of potential solutions that can be implemented by the project team maintain strong relationships with key stakeholders and partners in collaborative efforts (universities, government agencies, not-for-profit organizations, pharma/biotech companies) liaise with internal and external stakeholders, such as CHDI legal and finance, other clinical team members, institutional review boards, and site staff (as needed), etc. develop and/or oversee development of other project-related documents including protocols, case report forms, study manuals, SOPs, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed anticipate areas of risk, and plan and implement solutions to mitigate these risks assure good communication among the project team which is made up of members from within the organization and outside vendors/collaborators track and report on progress of clinical projects to the extended project team and management as appropriate Qualifications The successful candidate will have: Bachelor's or Master's degree in life sciences, health sciences, project management, regulatory, clinical research, or related field experience in pharmaceutical industry/biotech/CRO/TMF management/academic experience in clinical research project/trial management including budgeting, contracting and study execution experience in managing vendors and eTMF systems, including RFP processes and contract negotiations

Responsible for the overall operation of one or more research studies, coordinates research through project recruitment, scheduling and retention of study subjects and exercising appropriate communication skills in order to ensure retention of subjects in the study. This is a fully grant-funded position. Essential Functions Assist in identifying and recruiting eligible participants for research study. Ensure coordination of subjects and study personnel as required by protocol. Act as liaison between study personnel and study participants. Encourage and motivate participants to maintain compliance and attendance throughout the duration of the study and coordinate all aspects of retention. Maintain study records and related documentation as required by protocol and regulatory bodies (internal and external). Work with external study sites and coordinating centers as required. Participate in study meetings (in-person and by phone) as required. Perform study related testing and/or procedures as certified/trained. Maintain the highest level of confidentiality regarding patient and study records. Assist in the training of study support staff and student interns as assigned. Support and complete all study related paperwork including requirements of the Internal Review Board. Conduct screenings of preschool children as necessary to maintain recruitment goals (after training). Other related duties as assigned. Required Qualifications Minimum of Bachelor's Degree in or the equivalent combination of education and work experience. Please review the Equivalency Chart for additional information. Minimum of Experience working in a research environment desirable Proficiency in computer based operations including word processing, spreadsheets, REDCap and data base software. Excellent time management and organizational skills Excellent record keeping skills Ability to work independently Excellent interpersonal skills Comfortable working with children Familiarity with standard concepts, practices and procedures within study related field and study specific skills. Physical Demands Typically sitting at a desk/table Location The Eye Institute - Oak Lane Additional Information This position is classified as Exempt, grade J Compensation for this grade ranges from [$ 47,490 to $71,230 per year] [. Please note that the offered rate for this position typically aligns with the minimum to midrange of this grade, but it can vary based on the successful candidate's qualifications and experience, department budget, and an internal equity review. Applicants are encouraged to explore the Professional Staff salary structure and Compensation Guidelines & Policies for more details on Drexel's compensation framework. For information about benefits, please review Drexel's Benefits Brochure. Special Instructions to the Applicant Please make sure you upload your CV/resume and cover letter when submitting your application. Additional Required Documents A review of applicants will begin once a suitable candidate pool is identified.

Part Time Clinical Research Coordinator-Opthalmology25000971Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The part-time Clinical Research Coordinator will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators to provide research support requiring the application of standard clinical research practices. The Clinical Research Coordinator will be responsible for the planning, implementation, and execution of Clinical Trials in the Ophthalmology department at the Temple University Lewis Katz School of Medicine. Currently, the department's research focuses on AI assisted diabetic retinopathy screening, Thyroid eye disease and intraocular lens for cataract surgery. Essential Functions: Responsibilities include assisting with screening, tracking and enrolling patients in active clinical trials; obtaining informed consent; scheduling and conducting study visits; preparing IRB submissions; acting as the primary contact for study sponsors and participants, processing and shipping laboratory specimens, interacting with study sponsors, faculty and staff, and collecting and entering study data into study database. The incumbent will schedule and participate in sponsor meetings and resolve queries in a timely fashion. Assist with start-up activities for new studies including feasibility review and pre-start up sponsor meetings. At Temple, you will find it easy to fit in while staying true to yourself. We value what makes each employee unique and strive to maintain a culture of diversity and inclusion. As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity. Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or health professions 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: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred Skills and Abilities: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant funded position. This position is assigned a hybrid work arrangement (on-campus and remote), the duration of this hybrid work arrangement is at the discretion of Temple University and the Department. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. 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. Click here. 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)-Kresge Science HallWork Locations: Kresge Science Hall Schedule: Part-time Job Posting: Apr 16, 2025, 7:51:09 PM

We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will be responsible for recruiting, screening, and enrolling subjects into clinical trials, explaining the informed consent process, and documenting adverse events. You will also be responsible for collecting study documents, protocols, regulatory documents, informed consents, case report forms, and source documents, as well as preparing Institutional Review Board (IRB) applications. Responsibilities * Recruit, screen, and enroll subjects into clinical trials * Explain the informed consent process to patients * Document adverse events * Collect study documents, protocols, regulatory documents, informed consents, case report forms, and source documents * Prepare Institutional Review Board (IRB) applications Essential Skills * Experience in patient recruitment and consenting * Experience with adverse event reporting * Effective communication and writing skills * Knowledge of IRB and human research protection regulations * 1-3 years of clinical research experience Additional Skills & Qualifications * BA/BS preferred * Experience with in-hospital clinical research Work Environment This role involves a combination of office and hospital/outpatient surgery settings. The work environment is very fast-paced with a high volume of industry and investigator studies. You will be working in one of the most prestigious academic research institutes in the world, utilizing state-of-the-art equipment, and working on high-profile studies with well-known sponsors. Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information. Pay and Benefits The pay range for this position is $25.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 30, 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Bilingual Clinical Research Coordinators at our Keystone Clinical Studies site in Plymouth Meeting, PA! The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends) Compensation: Hourly Rate based on experience + comprehensive benefits, PTO, and 401k match *paid overtime for weekend work, evening work, or early morning work as needed RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. QUALIFICATIONS Bachelor's degree preferred, but not required Experience working neurology studies is a plus, but not required - this site primarily conducts Alzheimer's clinical studies Phlebotomy experience is required, EKG or other patient labs/processes preferred Preferably 2+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

Clinic Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Any other matters, as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is preferred

Could you be our next Clinical Research Assistant at Lankenau Institute for Medical Research? Why work as a Clinical Research Assistant with Main Line Health? * Make an Impact! As a Clinical Research Assistant, you will be supporting clinical research personnel in the implementation and management of clinical research activities. You will be assisting in screening and enrolling potential study patients as specified per protocol as assigned. Collaborate with your team in collecting and entering date required for research study. * Develop and Grow your Career! Invest in furthering your education through seeking certifications or advanced degrees by taking advantage of our Tuition Reimbursement! This position is eligible for up to $6,000 per year based upon your Full or Part Time status. * Join the Team! Like our patients, the Main Line Health Family encompasses a wide range of backgrounds and abilities. Just as each of our patients requires a personalized care plan, each of our employees, physicians, and volunteers, bring distinctive talents to Main Line Health. Regardless of our unique design, we all share a purpose: providing superior service and care. * Position-Specific Benefits include: We also offer a number of employee discounts to various activities, services, and vendors... And employee parking is always free! Position: Clinical Research Assistant Shift: Day Shift Experience: 1. Experience with Microsoft Office required. 2. Good verbal and written communication skills. Education: BS preferred or equivalent experience in clinical research preferred. Licensures/Certifications: N/A Additional Information * Requisition ID: 74757 * Employee Status: Regular * Schedule: Full-time * Shift: Day Job * Pay Range: $18.01 - $27.91 * Job Grade: 205

Clinical Research Coordinator Nephrology/Opthalmology - (25000844) Description Grade: T25 The link below will give you information about the University's “T”salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Clinical Research Coordinator will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators to provide research support requiring the application of standard clinical research practices. The Clinical Research Coordinator will be responsible for the planning, implementation, and execution of Clinical Trials for both the Department of Medicine/section of Nephrology and Ophthalmology departments at the Temple University Lewis Katz School of Medicine. Performs other duties as assigned. Essential Functions: Responsibilities include assisting with screening, tracking and enrolling patients in active clinical trials; obtaining informed consent; scheduling and conducting study visits; preparing IRB submissions; acting as the primary contact for study sponsors and participants, processing and shipping laboratory specimens, interacting with study sponsors, faculty and staff, and collecting and entering study data into study database. The incumbent will schedule and participate in sponsor meetings and resolve queries in a timely fashion. Assist with start-up activities for new studies including feasibility review and pre-start up sponsor meetings. Additional responsibilities include working independently to drive day to day research activities, supporting multiple active protocols simultaneously, assisting with investigator-initiated research, writing protocols, submitting studies to local and central IRBs, maintaining regulatory compliance and documentation, updating study records on clinicaltrials.gov, and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations and Temple policies. Performs other duties as assigned. At Temple, you will find it easy to fit in while staying true to yourself. We value what makes each employee unique and strive to maintain a culture of diversity and inclusion. As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity. Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or health professions 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: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred Skills and Abilities: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). Hybrid work opportunities may be available. Duration and arrangements at the discretion of Temple University and the Department. This position requires a background check. This position requires Child Abuse Certifications prior to the commencement of service. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. 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. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. 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)-Kresge Science HallJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will be responsible for recruiting, screening, and enrolling subjects into clinical trials. You will also play a key role in explaining the informed consent process, documenting adverse events, and collecting various study documents and protocols. Additionally, you will prepare Institutional Review Board (IRB) applications. Responsibilities * Recruit, screen, and enroll subjects into clinical trials * Explain the informed consent process to study participants * Document adverse events in a timely and accurate manner * Collect study documents, protocols, regulatory documents, informed consents, case report forms, and source documents * Prepare and submit Institutional Review Board (IRB) applications Essential Skills * Experience with patient recruitment and consenting * Strong understanding of the informed consent process * Proficiency in documenting adverse events * Knowledge of IRB and human research protection regulations * 2+ years of clinical research experience * Effective communication and writing skills Additional Skills & Qualifications * Bachelor's degree (BA/BS) preferred * Experience with in-hospital clinical research * Familiarity with oncology clinical trials * Knowledge of Good Clinical Practice (GCP) and Electronic Data Capture (EDC) Work Environment This position involves working in a combination of office and hospital/outpatient surgery settings. The work environment is very fast-paced with a high volume of industry and investigator studies. You will be part of one of the most prestigious academic research institutes in the world, working with state-of-the-art equipment on high-profile studies sponsored by well-known organizations. Pay and Benefits The pay range for this position is $28.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 30, 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Clinical Research Coordinator-Obstetrics - (25000641) Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Lewis Katz School of Medicine has an exciting opportunity for a clinical research Coordinator (CRC) to work on a translational grant funded by the National Institutes of Health that seeks to identify biomarkers and examine factors that are likely to influence the consequences of fetal alcohol exposure during pregnancy. The CRC will work under the Director, CRORA and will work closely with the research team of clinical and basic scientists to carry out all clinical aspects of this project. The CRC will recruit study participants, obtain informed consent, administer questionnaires, collect urine and blood samples, and assist with specimen processing and perform data management. The CRC will be involved with all day-to-day study activities and will be an integral member of the study team. Essential Functions: • Submissions to IRB for review and approval; • Maintenance of regulatory and study-related documents; • Patient recruitment and tracking participants throughout the study; • Obtaining informed consent; • Administration of the alcohol exposure questionnaire; • Storage of all clinical samples; • Oversee collection of blood samples from 300 subjects during their first visit with the OB/GYN team (first trimester), then during their follow-up visits during their second and third trimesters; • Processing, aliquoting and storing blood samples and urine in a freezer; • Perform all the biochemical and molecular assays, maintain inventories, order supplies, and generally will participate in the organization of the laboratory; • Data management and data entry; • Responsible for preparation of exosomal RNA and protein samples from serum, from EtOH-used subjects and controls; • Organizing matching groups for Controls and alcohol consumed cases for further biomarkers assays. Benefits of working at Temple University include: 403(B) Retirement Plan Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or Health Professions field and at least three years of directly related experience. An equivalent combination of education and experience may be considered. Required Skills: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. 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. Click here. 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) Job: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Unblinded Clinical Research Coordinator DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP. Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans. Provide consultative support regarding the preparation and dosing of drugs. Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. Understand and apply all applicable site procedures. Ensure receipt and proper storage of IP and bioretention samples. Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. Review protocols and provide input on clinical and pharmacy supply needs. Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. Temperature reporting. Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. Knowledge & Experience: Education: High School Diploma or equivalent required Foreign Medical Graduate is a plus Pharmacy Technician Certification a plus Experience: Clinical Experience Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Docs. Excellent communication and customer service skills. Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred but not required

Clinical Research Coordinator-Obstetrics - (25000641) Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Lewis Katz School of Medicine has an exciting opportunity for a clinical research Coordinator (CRC) to work on a translational grant funded by the National Institutes of Health that seeks to identify biomarkers and examine factors that are likely to influence the consequences of fetal alcohol exposure during pregnancy. The CRC will work under the Director, CRORA and will work closely with the research team of clinical and basic scientists to carry out all clinical aspects of this project. The CRC will recruit study participants, obtain informed consent, administer questionnaires, collect urine and blood samples, and assist with specimen processing and perform data management. The CRC will be involved with all day-to-day study activities and will be an integral member of the study team. Essential Functions: • Submissions to IRB for review and approval; • Maintenance of regulatory and study-related documents; • Patient recruitment and tracking participants throughout the study; • Obtaining informed consent; • Administration of the alcohol exposure questionnaire; • Storage of all clinical samples; • Oversee collection of blood samples from 300 subjects during their first visit with the OB/GYN team (first trimester), then during their follow-up visits during their second and third trimesters; • Processing, aliquoting and storing blood samples and urine in a freezer; • Perform all the biochemical and molecular assays, maintain inventories, order supplies, and generally will participate in the organization of the laboratory; • Data management and data entry; • Responsible for preparation of exosomal RNA and protein samples from serum, from EtOH-used subjects and controls; • Organizing matching groups for Controls and alcohol consumed cases for further biomarkers assays. Benefits of working at Temple University include: 403(B) Retirement Plan Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or Health Professions field and at least three years of directly related experience. An equivalent combination of education and experience may be considered. Required Skills: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. 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. Click here. 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) Job: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will be responsible for recruiting, screening, and enrolling subjects into clinical trials, explaining the informed consent process, and documenting adverse events. You will also be responsible for collecting study documents, protocols, regulatory documents, informed consents, case report forms, and source documents, as well as preparing Institutional Review Board (IRB) applications. Responsibilities * Recruit, screen, and enroll subjects into clinical trials * Explain the informed consent process to patients * Document adverse events * Collect study documents, protocols, regulatory documents, informed consents, case report forms, and source documents * Prepare Institutional Review Board (IRB) applications Essential Skills * Experience in patient recruitment and consenting * Experience with adverse event reporting * Effective communication and writing skills * Knowledge of IRB and human research protection regulations * 1-3 years of clinical research experience Additional Skills & Qualifications * BA/BS preferred * Experience with in-hospital clinical research Work Environment This role involves a combination of office and hospital/outpatient surgery settings. The work environment is very fast-paced with a high volume of industry and investigator studies. You will be working in one of the most prestigious academic research institutes in the world, utilizing state-of-the-art equipment, and working on high-profile studies with well-known sponsors. Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information. Pay and Benefits The pay range for this position is $25.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 28, 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Clinical Research Coordinator II The Clinical Research Coordinator II, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). 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). Demonstrating 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). 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. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. 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 a preferred Foreign Medical Graduates preferred Experience: At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is a plus