Clinical Research Associate Jobs in Greentree, NJ

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. - Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. - Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. - Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. - Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. - Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. - Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. - Collaborate and liaise with study team members for project execution support as appropriate. - If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. - If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications - Bachelor's Degree Degree in scientific discipline or health care preferred. Req - Requires at least 2 years of year of on-site monitoring experience. Req - Equivalent combination of education, training and experience may be accepted in lieu of degree. Req - Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. - i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Good therapeutic and protocol knowledge as provided in company training. - Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). - Written and verbal communication skills including good command of English language. - Organizational and problem-solving skills. - Effective time and financial management skills. - Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

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, PTO and 401K

The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product. Responsibilities * Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol. * Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research. * Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects * Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies * Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits * Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance * Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem * The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. * Skills:* CRA, Monitoring, Medical Device, CRO, ICH, GCP, FDA, Clinical Research, Clinical Trials * Top Skills Details:* CRA,Monitoring,Medical Device * Additional Skills & Qualifications:* Bachelor of Science Degree 4-5 Years + experience with a Sponsor or CRO Site Monitoring Experience Work experience at more than 1 company Experience with set-up monitoring plan, conducted site monitoring, and conducted site close-out. Medical Device preferred, Pharma OK, CRO OK * Experience Level:* - Entry Level

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.

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

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

About Us At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development. Discover why Cooper University Health Care is the employer of choice in South Jersey. Short Description * Plans, organizes, coordinates, directs and personally participates in major cancer research projects, including development and implementation of research protocols and grant proposals• Reviews and analyzes resulting research data, revises techniques or approaches to work problems as indicated as necessary by research data.• Compiles, writes and submits project results to principal investigator or Director of Surgical Research. • Assists Surgery/Oncology trainees in preparation of research papers, reports and abstracts for publication as one of co-authors, or one of the co-corresponding authors, or the corresponding author. • Designs, develops or adapts equipment used in experiments or research to obtain desired results. • Plans and supervises training of Surgery/Oncology trainees, technicians and other laboratory personnel with respect to proper laboratory techniques, use of laboratory equipment, and safety procedures. • Confers with industrial, governmental or other groups concerning progress or results of research project. • Supervises large group of employees engaged in performance of technical and professional work, which varies from routine to complex laboratory work tasks. • Applying for research grants from funding agencies is highly encouraged• Performs other duties as assigned Experience Required Highly-qualified scientists with a demonstrated ability to lead independent research projects, with experience in mentoring, training and project management. Translational cancer Research experience with strong background preferably on Lung Cancer, GI Cancer, or Breast Cancer with expertise in kinase signaling, drug resistance, surgical research. Proficiency in molecular techniques including bioimaging, flow cytometry, and animal model is preferred. Education Requirements Ph.D., MD, or MD/PhD or equivalent required.

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.

Clinical Research Study Manager The Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Adherence and compliance to the assigned protocols at their respective site(s). Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s). Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s). Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner. Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner. Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation. Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines. Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial. Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site. Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. 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

Haverford College invites applications for our full-time (37.5 hours per week), fixed-term (2 year appointment), non-exempt, benefits-eligible Coordinator of the Michael B. Kim Institute opportunity. Haverford Offers Great Benefits The College offers a comprehensive benefits program that includes possible work-from-home opportunities, automatic 10% retirement contribution to your retirement account upon eligibility (no match required), a 50% tuition benefit for dependent children upon eligibility, 14 paid holidays (including the week before New Year's Day off), Health Savings Account contribution of $700 for individuals and$1400 for families (no match required), affordable medical plans, and a beautiful arboretum campus with walking trail and easy public transportation access. Please visit the Benefits page (*************************************************** for more information. Work Location: This position will be eligible for a hybrid work schedule, pursuant to the College's Work Location Policy. About the Michael B. Kim Institute for Ethical Inquiry and Leadership The Michael B. Kim Institute for Ethical Inquiry and Leadership is a new initiative at Haverford College that will highlight and expand the College's engagement with ethical questions by expanding and refining curriculum, bringing high-profile speakers to campus to address critical questions with ethical implications, and supporting new programming which highlights the importance and complexity of ethical inquiry. About the Position Reporting to the Institute Faculty Director, the Coordinator will play an active role in all aspects of the Institute's administration and activities, including coordinating Institute programming and serving on the Institute Steering Committee. Among their responsibilities, the Coordinator will assist in managing all Institute operations including budget and campus communications. The Coordinator also will provide support for the development of the Institute's home in a new campus building. Primary Responsibilities * Manage Institute activities including coordination with partnership offices and organizations, campus visitors, and the Haverford public events calendar * Manage all event needs including logistics and communications * Provide administrative support for the Institute including expense reconciliation and budget tracking * Coordinate the Institute's programming * Support and participate in the Institute Steering Committee * As needed, hire and supervise student workers Line of Report: The Coordinator of the Michael B. Kim Institute reports to the Institute's Faculty Director. Minimum Qualifications * Bachelor's Degree or equivalent relevant experience * 2 years of experience in an office environment Professional Competencies * Excellent project management skills with the ability to prioritize tasks and meet deadlines * Ability to work independently and collaboratively in a team environment * Ability to build relationships with individuals from different backgrounds with diverse life experiences * Strong attention to detail and a high level of accuracy * Effective communication skills including proofreading * Strong knowledge of Microsoft Office and Google Suites * Capacity to learn new applications and platforms Preferred Qualifications * Experience with event development/management * Experience with higher education We are aware that some people are less likely to apply for jobs unless they meet qualifications as described in the job advertisement. We are most interested in finding the best candidate for the job, and recognize that a successful candidate may come from a less traditional career trajectory, and have skills and abilities gained outside a classroom context, or an equivalent skill set. We encourage you to apply and share how you meet the position's qualifications. To Apply: Interested applicants are invited to submit an application, to include a cover letter and resume by visiting ********************************************************************************************************************** The application deadline is May 5, 2025. Application review will begin after the deadline has passed. Please email ***************************** with questions about submitting your materials. Should the search committee be interested in pursuing your candidacy, you will hear from them directly. Finalists will be asked to provide three professional references. Haverford College is an Equal Opportunity employer committed to diversity, equity, inclusion, social justice, and providing equal opportunities and access to all individuals regardless of race, ethnicity, religion, gender identity, sexual orientation, national origin or ancestry, age, marital status, disability, or veteran status. Women, non-binary and transgender individuals, people of color, Indigenous people, and those with other or multiple historically marginalized and/or underrepresented identities are especially encouraged to apply. We at Haverford College recognize that we live and work on Lenape land and pay respect and honor to the caretakers of this land, from the time of its first human inhabitants until now, and into the future. We seek to maintain and build upon our current and ever-evolving connections with members of Lenape tribes and communities, in recognition of our intertwined histories and with a goal of moving toward right relationship between the Haverford of today and Lenape peoples. Shelley Harshe Director of Talent Acquisition, Equity and Belonging

Zydus Therapeutics is a clinical stage, specialty-focused bio-pharmaceutical company focused on developing transformative treatments to transform lives, starting with rare and serious liver diseases and anemias. Our purpose is simple, to empower people with the freedom to live healthier and more fulfilling lives, by unlocking new possibilities in life sciences and providing quality healthcare solutions. Our lead drug candidate, Saroglitazar, is a liver-selective, dual peroxisome proliferator-activated receptor (PPAR) alpha / gamma agonist. Saroglitazar is an investigational treatment which has received Fast Track designation and orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of patients with primary biliary cholangitis (PBC). Saroglitazar is also an investigational treatment in development for the treatment of non-alcoholic steatohepatitis (NASH). Our second drug candidate is Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF- PH) inhibitor, an investigational treatment in development for the treatment of chemotherapy-induced anemia (CIA). As a wholly-owned subsidiary of Zydus Lifesciences, our pipeline is fueled by 1,300 researchers who are working with cutting-edge technologies to discover new medicines for tomorrow. Zydus Therapeutics, Inc. is seeking a candidate for the role of Senior Clinical Project Manager (Sr. CPM) is responsible for the planning, execution, and oversight of clinical trials across multiple phases, ensuring compliance with regulatory requirements, timelines, and budget constraints. This role involves cross-functional team leadership, vendor management, and collaboration with key stakeholders, including investigators, regulatory agencies, and internal teams. The Sr. CPM will play a pivotal role in driving operational excellence in clinical trial execution. RESPONSIBILITIES: • Lead end to end clinical trial management from protocol development to study closeout. • Develop and maintain detailed project plans, timelines and budgets. • Collaborate with regulatory teams for submissions, amendments, and compliance-related documentation. • Address protocol deviations, audit findings and inspection readiness. • Select, negotiate and mange relationships with CROs, central labs and other external vendors. • Track performance metrics and ensure service level agreements are met. • Proactively identify study risks and develop mitigation strategies. • Address operational challenges, protocol deviations and recruitment/retention issues • Ensure efficient resource allocation to optimize study costs. • Monitor trial related invoices and payments in collaboration with finance teams. • Act as primary point of contact for all internal and external stakeholders. • Provide leadership and mentorship to junior project managers, CRAs and study coordinators. • Foster collaboration among cross functional teams, including Clinical Operations, Data Management, Medical Writing, Quality Assurance and Quality Control, Legal, Finance, and Senior Leadership, as well as external partners (CROs, Laboratories, Specialty service-providers, Investigators). • Ensure high quality data collection and adherence to data integrity standards. • Work closely with data management and biostatistics teams to ensure timely database locks. • Provide regular study updates to senior leadership and stakeholders. • Develop strategies to optimize patient recruitment and retention. • Oversee site relationships, investigator engagement and performance metrics. • Support protocol development and feasibility assessments. • Contribute to clinical development plans, study endpoints and operational feasibility considerations. • Contribute to developing the organizational systems, including development of the SOPs, document management system and project finance management. • Ensure compliance to regulatory requirements/ standard operating procedures and timely management of project activities. • Any other duties as assigned by Supervisor. Requirements QUALIFICATIONS - SKILLS & REQUIREMENTS: • Skills & Competencies: o Strong leadership, communication, and negotiation skills. o Ability to work in a fast-paced environment and manage multiple priorities. o Proficiency in clinical trial management systems (CTMS), EDC, and regulatory submission platforms. o Excellent problem-solving and risk management abilities. o Financial acumen for budget forecasting and cost control. EDUCATION & EXPERIENCE: • Education: o Bachelor's degree in life sciences, pharmacy, nursing, or a related field (Master's or PhD preferred). • Experience: o 7+ years of experience in clinical trial management within the pharmaceutical, biotech, or CRO industry. o Proven experience in leading Phase I-IV clinical trials. o Strong understanding of GCP, ICH guidelines, FDA, EMA, and other regulatory requirements. o Experience managing CROs, vendors, and multi-site global trials. • Preferred Experience: o Prior experience in neurology, rare diseases is a plus. o Experience working in an FDA-regulated and/or EMA-regulated environment. o Knowledge of adaptive trial designs and decentralized clinical trials is an advantage. TRAVEL: • This position will require domestic and international travel (10%). WORK ENVIRONMENT: This is an office-based position, located in our office in Pennington, NJ. The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is: • Frequently required to sit and/or stand, walk, talk, and hear. • Ability to sit at a computer for an extended period of time. • Vision ability requirements include clarity of visions at 20 inches or less due to computer work. • Moderate noise (i.e., background noise due to computers, phone, printers, and light hallway traffic). • Constantly required to use hands and fingers to operate office machines and equipment. • Frequently required to reach with hands and arms. Occasionally required to stoop, kneel, and crouch. The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job. Zydus Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Zydus is committed to providing reasonable accommodation to, among others, individuals with disabilities and disabled veterans. If you need an accommodation because of a disability to search and apply for a career opportunity with Zydus, please contact us and let us know the nature of your request.

Job Details Experienced RO Marlton - Marlton, NJ Full Time Occasional Inter-Office Travel Day ShiftDescription The Clinical Operations Specialist provides a blend of clinical and operations support to the office. Clinically, the COS will function as a Medical Assistant, Non-Surgical Clinical Assistant, or any other applicable clinical role as needed. In this capacity they will ensure the smooth flow of patients during office hours and support a variety of clinical and administrative functions. Operationally, the COS will serve as a Front Desk Receptionist or Front Desk Therapy Receptionist. The team member is responsible for greeting, checking in, verifying insurance, obtaining insurance referrals and any other applicable administrative tasks as needed. In this role the COS serves as a liaison between the patient and the medical staff in the office. The COS is an Operational role designed to meet the operational needs of the office - regular travel and schedule flexibility are inherent in this position. Key Accountabilities: Excellence in patient satisfaction, compliance with schedule prepping, responsiveness to voicemails, emails, and clinical messages, timeliness with pre-certifications and authorizations, compliance with all clinical policies and procedures, and adherence to documentation standards. Accurate collection of copays and capturing of referrals, efficient documentation of demographic and insurance information, obtaining referrals, excellence in time management and indepedent problem solving ability. As this is a support role designed to fill operational needs, utmost reliability and punctuality are vital. Essential Duties: Greet patients and visitors in a prompt, courteous, helpful manner. When applicable, maintain flow of patients from waiting room to exam room to discharge. Upon completion of their appointment, direct them to surgery scheduling and/or to the exit. Demonstrates a commitment to delivering unsurpassed service and quality patient care recognized by Patients, Physicians, Clinical Teams, Peers Check patients in by entering, verifying, and updating demographic and insurance information. Record arrival times, referral information, and payment information. Ensure RCM Console and Ready to Bill errors are addressed daily to ensure timely claims submission. Ensure referrals have been received, are in the patient's chart and attached Make follow up appointments for patients when needed or act as liaison to appropriate ancillary departments such as physical therapy and MRI. Answer telephone calls in friendly and professional manner, answer questions within their scope of knowledge, forward/transfer calls to the appropriate team members or take messages as needed. Handle correspondence within 24 hours of reception. Assist patients with ambulatory difficulties through the office. Follow procedure for requests for medical records and for Disability/FMLA paperwork. Take payment when necessary and document requests in the patient chart. Accurately batch out at end of shift and ensure all payments balance. Complete assigned paperwork and escalate any discrepancies to the office manager. Assist other team members with upset or irate patients by deescalating the situation and providing support. Maintain workspace in a neat and organized manner. Stock supplies in the lobby, front desk, pod workspaces, and exam rooms. Prep the schedule by obtaining referrals, confirming coverage status, and checking for any potential issues in advance of patient appointments. Reach out to patients prior to appointment when needed. Print out front sheets, last notes, and other requested documentation for the physician team. Attend meetings, participate in office activities, teambuilding exercises or special projects as required. Exemplify the culture and values of the organization in all interactions. Clean and autoclave instruments using proper sterile technique. Records vitals and medical history in the patient chart in accordance with MIPS guidelines, scan all pertinent documents into patient chart, obtain and record vitals, request and make available reports and images from outside facilities. Pull up/load/import pertinent studies for the physician, prepare for injection and aspiration procedures, dispose of biohazardous waste in accordance with OSHA regulations, replace sharps containers when full. Bring patients back to see the physician in efficient and timely manner; assist patients with clothing and preparing the body area to be examined. Empty and restock laundry. Complete pre-certifications and authorizations for imaging studies and injectable medications. Submit requests for authorizations to centralized departments as applicable. Provide follow up care and instructions to patients at conclusion of their appointment. Applies or removes casts/splints. Make orthotic devices by bending, forming and shaping materials to prescribed specifications. Fit, test and evaluate devices on patients and make adjustments for proper fit, function and comfort. Reads and responds to email communications within appropriate time frame. Identifies weekly schedule, including schedule changes, published by manager. Handle specimens (including urine, blood and drainage from incisions, aspirated fluids, etc.) and label accordingly. Follow order instructions of provider to ensure specimen is sent to appropriate lab for analyzation. Qualifications: High School Diploma or equivalent Active national Medical Assistant certification preferred Current CPR certification required Minimum (1) year in a medical office environment Medical office procedures and terminology Computer skills including but not limited to MS Office. Experience with scheduling and billing systems and EMR preferred. Basic medical assistant skills including phlebotomy, handling of body fluid samples, removal of sutures and staples, OSHA regulations preferred. Our Commitment to Employees: Come work at Rothman Orthopaedics! Our employees are our single greatest asset, as such, we strive to provide a professional, nurturing environment where every member of our team can make a meaningful difference in the lives of others. This commitment to our employees has earned us the distinction as a Top Workplace in Philadelphia by the Philadelphia Inquirer year after year. Our employees enjoy competitive pay, comprehensive health and dental benefits, tuition reimbursement, paid time off, and retirement savings plans. Rothman Orthopaedics is an Equal Opportunity employer committed to providing opportunities to all qualified applicants without regards to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. We value developing an inclusive and equitable environment that strengthens our organization and allows us to better attract and retain a diverse workforce that is representative of our patients and our community. We model our values by creating and enacting practices that encourage participation from all backgrounds, perspectives, and experiences. COVID-19 Policy: As a condition of employment at Rothman Orthopaedics, it is required you receive the COVID-19 vaccination. Rothman Orthopaedics is an Equal Opportunity Employer and requests for reasonable accommodations will be considered. Qualifications

Job Details Works under direct supervision and assists research coordinators with organizing, gathering and compiling clinical research data. Tracks and maintains credentialing documentation for staff and all researchers participating in clinical trials in accordance with IRB regulations. May provide clerical and technical support to ensure adherence to research protocols and quality of information received. Job Description Essential Functions: Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson. Performs a variety of research, data base and clerical duties in support of clinical trials to assist investigators in organizing, gathering and compiling clinical research data. Organizes and maintains documentation required for clinical trial(s). Informs Principal Investigator and/or designated individual on any issues concerning patient's response to treatment/medication/ any adverse effects overall to patients. Assists Principal Investigator with IRB filings and annual reviews. May assist in the enrollment of human subjects. Minimum Education and Experience Requirements: Education: Minimum High School Diploma or equivalent. AND Experience: Experience in research or clinical setting preferred. Work Shift Workday Day (United States of America) Worker Sub Type Temporary Primary Location Address 833 Chestnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. Smithers PDS is seeking a Study Coordinator II to join our team in Ewing, NJ. This position assists the Project Manager in performing study-related critical activities. These activities include: (1) authoring and/or QC of analytical plans and reports, Watson and Excel data retrieval, (2) QC of data tables and reports and all study supporting documentation and (3) identifying issues and deviations that affect the quality of study-related data and communicating these to the Project Manager or appropriate department manager. This position is paid on a salary basis and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments. Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated. Salary for range for this position is $60,000 - $75,0000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO. Primary Responsibilities • With input and supervision from the Project Manager, assist in drafting Analytical Plans and Reports to support all phases of the business (Transfer, Validation and Sample Analysis) using Smithers or client specific templates. • Assist the Project Manager with meeting client deadlines. This requires a complete understanding of the status of each active project and the agreed upon project timelines and deliverables. • Create data summary tables from Watson LIMS and various Excel spreadsheet formats. • Reviews run folders, notebooks, and other study documentation. • Assure that all run folders, data tables and reports move through the internal process including QAU in sufficient time to meet client timelines. • Assure that all QC and QA findings are responded to in a timely fashion and are complete and accurate. • Assure that all study related information is archived on date that the report is finalized. • Assist the Project Manager in supplying data releases, plans, and reports to clients. • Attend Client Conference calls and provide meeting minutes for client conference calls when required. • Other duties as assigned. Additional Requirements: • Knowledge of GLP. • Ability to multi-task and participate in multiple studies concurrently. • Ability to ensure high quality data while working under the pressure of strict deadlines. • Overtime and weekend work as required. • Work may require the use of PPE (personal protective equipment). Corporate Responsibilities: • Adherence to laboratory health and safety procedures. • Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines. • Adherence to federal and/or local regulations, as applicable. Education and Experience Requirements: • Minimum of a Bachelor's Degree in the Biological Sciences or equivalent experience preferred. • Minimum of 2 years in a QC/QA role at a GLP, GMP facility, at least 1 of which occurred in an analytical laboratory environment under GLP regulation. • Immunochemistry experience is preferred. • Extremely strong competence using Microsoft Word and Excel especially with various formatting features. • Functional knowledge of Watson LIMS a plus. • Must be detail oriented, well organized with exceptional communication skills. • Must have sufficient scientific background to understand scientific concepts of ligand binding assays (biomarkers, PK, immunogenicity, and cell-based assays). • Must be familiar with all GLP requirements. #PharmaJobs #LI-MV1

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 Client develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. Client provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer's disease, epilepsy, migraine prevention and treatment), pain management, and women's health. Their ultimate goal is to help people live healthy lives. They have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. The Temperature Management Coordinator is responsible for day to day the execution management of the Temperature Management & Control for Clinical Supplies clinical supplies during the execution phase of clinical trials consistent with GMP guidelines with a specific focus on Temperature Management & Control of Clinical Supplies. This individual will follow standard operating procedures . Responsible for management of to all evaluate all temperature excursions associated to clinical supplies during the trial execution ensuring prompt resolution and compliance with all SOP, GMP, Quality, and Regulatory guidelines, contributing to successful subject dosing within Janssen Pharma R&D for all phases of clinical trials.. Act as a single point of contact accountable for the business critical need. Manage and adjust supply dispositions via inventory systems including IVR & IWR based on the outcome of the temperate out of range evaluation. Conduct issue resolution activities for the temperature excursion supply aspects of the clinical trials. This individual will Develop strong internal collaboration with collaborate with GCDO, DPD, and Quality stakeholders to ensure for TOR resolution and overall customer satisfaction. Interface with Global Trial Managers, Trial Supply Managers, Drug Product Development, and Quality to manage trial supply temperature excursions. Responsible for execution of Temperature Monitoring Coordinator role during trial feasibility and throughout trial execution driving robust temperature management within company for all phases of clinical trials. They conduct the Review and approval of all Investigational Site Temperature Management Equipment Questionnaire Approvals (TMEQ) for Cold Chain IMP. Act as subject matter experts for They serve as subject matter consultants on temperature management requirements including storage and monitoring capabilities. They Customizing customize protocol specific temperature out-of-range forms based on product attributes. Coordinating Obtain quotes request and complete PO setup process to centrally source temperature monitoring devices. Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction. Partner with Global Trial Managers, Local Trial Managers, Site Managers, Local Medication Coordinators, Clinical Supplies Design Leaders, and Central Business Operations in temperature management and issue resolution. Supports Contribute to business process improvement initiatives. Responsible for the Temperature Management & Control of all clinical supplies from feasibility throughout trial execution in company Qualifications A minimum of a High School Diploma is required . A Bachelor's Degree is preferred. Two years' experience in a multi-disciplinary environment or Pharma R&D area is highly preferred. Experience with quality system tools are preferred (e.g. Trackwise ). Experience with Interactive Response Technologies for Clinical Trials (e.g. inventory management functionality) is preferred. Experience with the following functions is preferred, clinical operations, logistics, quality assurance, clinical supply chain planning and drug product development. Demonstrated knowledge in Clinical Supply Distribution and Clinical Study execution /GCP is preferred. Intermediate to advanced software skills (e.g., Microsoft Excel, SharePoint, PowerPoint ) is required. Experience in a highly matrixed environment is preferred. Excellent written and verbal communication skills are required. Additional Information Kind Regards, Sasha Sharma 732-662-7964 Integrated Resources, Inc.

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.

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

Coordinates and facilitates the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provides leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety and data quality. The position will work closely with the members of the clinical research team to develop effective tools for close monitoring and reporting of trials accrual, and coordinate the timely study activation and submission of protocol amendments. This position supports the Fox Chase Cancer Center Office of Clinical Research at Temple University Hospital, Main Campus or East Norriton and Buckingham Campuses. In addition, this position is expected to interact with the institutional investigators, other members of the healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials. Flexibility in work schedule, when possible, must be maintained to ensure coverage of study responsibilities. Education Bachelors Degree (Required) Graduate Level Classes or Degree in a relevant program (Preferred) Combination of relevant education and experience may be considered in lieu of degree. Experience 2 Years direct experience in a healthcare setting preferably oncology or clinical trials or a minimum of 3 Years related experience (Required) General experience and knowledge of chemotherapy and/or radiation therapy administration (Preferred) Previous experience performing phlebotomy and specimen processing (Preferred) License/Certifications CCRC - Cert Clin Research Coordinator (Preferred) or CCRP - Cert Clin Research Prof (Preferred) or ACRP-CP - Assn Clin Res Prof - Cert Prof (Preferred) _ Your Tomorrow is Here! As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years. Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion. At Fox Chase, we consider defeating cancer to be our calling. Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in. It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known. Apply today to be part of the future of prevailing over cancer. Your Tomorrow is Here! Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here! Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.