Clinical Research Associate Jobs in Collingswood, NJ

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.

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description RESPONSIBILITIES: • The Supporting Clinician will provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program. • coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations and deviations for all analytical assays. • protocol and study training • Data review and interpretation • study and/or program scientific and integrity oversight • safety review and communication • regulatory document, study report and publication preparation and review • Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician • Support the preparation of other clinical documents as required • DATA REVIEW AND INTERPRETATION: o Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables o Responsible for review of patient level data across a study and coordinating with Lead Clinician for study level review as delegated o Study analysis and decision point preparation o Interprets data and is able to identify issues of moderate/difficult complexity o Conducts data review independently • STUDY MEDICAL OVERSIGHT: o Collaborates with the Lead Study Clinician(s) and COSTL to provide guidance during the execution of the study o Provide input into the monitoring plan • SAFETY: o Ensure timely communication of safety issues o Review and approval of subject narratives as delegated by the Lead Clinician • REGULATORY AND PUBLICATIONS: o Provide input, review and edit clinical study reports (CSR) o Provide full review of content and integrates information from literature and other sources as appropriate o Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses) o Audit responses as delegated by the Lead Clinician • CLINICAL PROGRAM IMPLEMENTATION: o Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues o Initiate and coordinate corrective action for major medical/safety/scientific study level issues o Along with Lead Study Clinician(s) and COSTL and with regard to medical/safety concerns, ensures study level issues are resolved o Collaborate with Lead Clinician and COSTL to arrive at major site level decisions based on input from the team o Coordinates with Lead Study Clinician(s) and COSTL to maintain study timelines o Along with the Lead Study Clinician(s) and COSTL and other study team members, participates in training of Study Management Staff and monitoring staff o In collaboration with the Lead Study Clinician(s) and COSTL and study team, ensures the clinical trial material requirements of the study are met o Ensure standard processes, tools, and procedures used consistently and globally o Participates in developing training strategy for study with the study team members Provide input into the preparation of study level training materials in collaboration with Lead Study Clinician(s) and COSTL and team members o Ensures appropriate filing of documentation in the trial master file Qualifications QUALIFICATIONS AND SKILLS NEEDED: • M.D., PhD, Pharm. D. Degree in science or health-related field preferred, will consider highly motivated and experienced MA or MS • 10+ years of pharmaceutical/CRO experience preferred TECHNICAL SKILLS: • Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field • Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents • Has independently authored clinical study documents • Has experience with participating in and informally leading an operational team • Applies knowledge of internal/external business challenges to facilitate process improvements • Has ability to proactively resolve issues and work independently with minimal supervision • Has working knowledge of statistics, data analysis, and data interpretation • Has exceptional written and oral communication and cross-functional collaborative skills • Is proficient in MS Word, Excel, and PowerPoint

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.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Title: Clinical Study Manager-Remote Location: Collegeville, PA Duration: 36 months Job Description: This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis. The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed. Additional Skills: pTMF, Inspection Readiness activities, Study conduct activities. Qualifications BS Additional Information For More information, Contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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.

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description • This role is to provide comprehensive project coordination support for reducing the risk of phishing by supporting Info Protect Culture Change Behavioral Research Project • Clinical experience is helpful but not mandatory • Provide operational support and project administration for the Info Protect Culture Change Behavioral Research Project. The role entails coordinating clinical project development and implementation, project monitoring and control, risk management, and project governance. Efforts must adhere to principles of transparency across the programs and enable comparability with other efforts. Incumbent will serve as an operational 'single point of contact'; Collaborate with internal and external partners and vendors; Develop and implement project activities as assigned by the project manager; Track study budget spend and report monthly; Review and reconcile invoices for payment approval; and create and maintain project documentation including project plans, meeting minutes and agenda, project risk and decision logs, and other documents needed for project execution. Qualifications • Experience running clinical trials or University studies not required but recommended. • Project Admin/Coordinator - Level of knowledge/expertise: Extensive capability and expert understanding Job Profile: project admin/coordinator Provide administrative project planning support to Programme/Project Manager as required and provide plans converted into various formats Convert the output of the PM meeting into a monthly report and maintain the ISAC and FPAC project tracking tools Provide support to the PMO as requested. • The Information Protection programme at multi-year global programme to protect information. Within the programme, there is an Information Protection Culture work stream with the goal to fundamentally drive worldwide employee culture change for protecting information through education and awareness.

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

Job Details Entry RO Marlton - Marlton, NJ Full Time None Flexible ScheduleDescription 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.

Study Setup and Specimen CoordinatorJob Title: Study Setup and Specimen Coordinator Reports To: Project Manager, Team Lead Full-time Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. POSITION OVERVIEW: Key responsibilities of the position: When a new specimen is received, the Study Setup and Specimen Coordinator needs to Process e-Manifest Update Specimen Trackers Provide update to the clients regarding specimen status Work with Specimen Processing (BioA and Central Lab) closely on Sample Management including specimen status, problem reconciliation, as well as generation of related SOPs Work with BioA closely on analysis status for studies Assist laboratory management and QA specialist with CAPA, Change Control, and other processes Trouble Shooting Other responsibilities as needed Requirements: Has a High School Diploma or higher Experience working with laboratory specimens Has excellent communication skills ESSENTIAL SKILLS include the following: The skills listed below are representative of those that are required to perform this job successfully. Interview questions should be designed to verify/validate that the candidate possesses the specified below. High level of accountability with self and others Hands-on approach with a desire to teach others Track record of challenging the status quo Team and action-oriented Problem-solving Priority setting Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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

The primary purpose of this position is to ensure all permitting and inspection needs of the company are met in a timely manner in compliance with individual laws and regulations at all levels, affiliated companies, offices, and multiple municipalities by maintaining, updating, renewing records, databases and research as assigned. ESSENTIAL FUNCTIONS: · Performs municipal permit research for dedicated locations. · Assist with research of Licensing, Permit, and Code requirements in new/existing locations · Maintain companywide Permit Database. · Complete municipal verifications for all company sales. · Responsible for researching 3rd party plumbers in applicable locations as business needs dictate. · Assist with standard operating procedures for the Compliance Department. · Supports Compliance Specialist as needed. · Performs back-up permit coverage for Administrative Staff. · Monitors various compliance reports on a weekly basis and reviews with Administrative Director. · Performs other job-related duties as assigned to meet business needs. ABILITIES AND PHYSICAL DEMANDS: · Must be proficient in reading and writing using the English language. · Demonstrate competency with computers and other electronic office/business equipment. · Must have working knowledge of Microsoft Office products. · Must have excellent data entry, organizational, customer service, written and verbal communication skills. · Follow all company policies and procedures as well as adhere to the company handbook and confidentiality agreement. Complies with all safety policies and procedures. · Performs other job-related duties as needed to meet business needs. · Must have the ability to multi-task, be detail oriented and perform duties in a timely manner. · Must be trainable, self-motivated, flexible and can work with minimal supervision. · Must have the ability to sit for extended periods of time while viewing a computer screen. EDUCATION AND OTHER REQUIREMENTS: High School diploma or general education degree (GED); or related experience and/or training: or equivalent combination of education and experience. CERTIFICATIONS, LICENSES, AND REGISTRATIONS: None required for this position. WORK ENVIRONMENT: For the most part, ambient room temperatures, lighting, and traditional office equipment as found in a typical office environment.

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Assoc Dir, Clinical Research Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or therapeutic area. Essential Functions of the Job (Key responsibilities) Development of protocols for clinical studies. Preparation of clinical development plans. Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other FDA submissions. Monitor, review and summarize safety and efficacy data in ongoing studies. Assist with study design for exploratory development. Will lead the clinical matrix teams for assigned compounds. Represent exploratory development on project teams. Develop relationships with appropriate consultants. Write abstracts and present data at scientific meetings, both internally and externally. Serve as liaison to project teams, CRO's and others. Qualifications (Minimal acceptable level of education, work experience, and competency) Degree in scientific/life-sciences field. Pharm. D. or Ph. D. preferred. Minimum of 2 - 4 years of experience in research with at least 1 or more years of drug development experience are required. Prior Oncology Drug Development experience a plus. Ability to multi-task and work in a fast-paced environment. Excellent written and oral communication skills. Strong Analytical ability. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.

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

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 (full-time) in Oncology supporting the Moseley Institute/NCCBD (Nemours Center for Cancer & Blood Disorders) - coordinates, implements and completes clinical research studies and/or clinical trials by assisting in screening hematology patients, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases, process and shipment of research samples, participation in continuous process improvement initiatives in the Delaware Valley. Please upload a RESUME and COVER LETTER outlining your qualifications and experience to the Nemours Job Portal. Essential Functions: 1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned 2. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals 3. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements. 4. Supports NCCBD's NCORP: NCI Community Oncology Research Program across the Nemours enterprise. 5. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner. 6. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance. 7. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems 8. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation 9. Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples 10. Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS. 11. Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed. Further attendance at Sponsor Coordinator meetings as needed for study related training. 12. Prepares for internal and external audits. Prepares corrective action plans as indicated QUALIFICATIONS: * Bachelor's degree in medical or science related field required; * Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience * Basic Life Support Certificate (may obtain upon hire) * Effectively uses Microsoft computer software; * Maintains the highest possible standards for work quality; accepts feedback; gives accurate information * Builds and fosters professional relationships with staff, families, and patients * Makes decisions when appropriate; manages resources prudently; schedules time efficiently; works independently * Demonstrates ability to coordinate and establish priorities among diverse tasks; * Effectively communicates verbally and in writing with patients, families, associates, and providers;