Clinical Research Coordinator Jobs in Camden, NJ

We are seeking a highly organized and experienced Clinical Research Associate (CRA) to assist with oversight of the day-to-day operational aspects of clinical trials. The Sponsor CRA is responsible for monitoring oversight, co-monitoring, and site management work to ensure that the CRAs working under the CRO(s) and the sites conducting the studies on behalf of our client, follow all applicable regulations, guidelines, and sponsor requirements. The CRA will work closely with study teams, investigators, and research sites to ensure the successful execution of clinical trials from start up through close out. Key Responsibilities Site Management and Monitoring: Perform site co-monitoring visits at various timepoints in the study (selection, initiation, monitoring and close-out visits) to ensure CRAs working for the CRO on behalf of the sponsor, are monitoring in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines May conduct independent monitoring visits across the life cycle of a trial as required. Assist with site feasibility efforts, investigator selection, and site initiation activities. Evaluate patient safety, data quality/integrity, and protocol compliance at study sites, including adherence to applicable regulations. Identify and resolve any issues related to the conduct of the study, data accuracy, or site performance. Escalate quality issues as appropriate. Study Documentation and Reporting: Create tracking tools, training materials, and presentations as needed. Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, data query generation and resolution, AEs, and protocol deviations. Ensure copies/originals (as required) of 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 CRO CRA monitoring oversight, including monitoring visit findings, tracking monitoring visits according to the Clinical Monitoring Plan, and by submitting regular co-monitoring visit reports. Ensure timely reporting of safety data and AEs to the appropriate stakeholders. Financial Management: May be accountable for site financial management according to executed clinical trial agreement and to review/approve site invoices. May be accountable to review CRO CRA expense reports to ensure that expenses fall within the parameters established between sponsor and CRO at the execution of the contract. Training and Support: Provide training and support to CRO CRAs and site staff regarding study protocols, GCP and applicable regulations. Support development of project subject recruitment plan on a per site basis. Support sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability. Assist CRO CRAs and vendors to troubleshoot site issues. May present at Investigator Meetings. May contribute to Study Newsletters. Regulatory Compliance: Ensure that study conduct complies with all applicable federal, state and local regulatory requirements (e.g. FDA, EMA, ICH-GCP). Review and ensure that all required regulatory documentation is submitted and maintained. Collaboration and Communication: Establish regular lines of communication with CRO CRAs and sites to manage ongoing project expectations and issues. Collaborate and liaise with study team members for project execution support as appropriate. Attend and actively participate in study team meetings by providing Clinical Operations updates. Collaborate with the clinical project team to prepare for audits and inspections by regulatory agencies. Qualifications Education and Certifications: Bachelor's Degree or higher. A degree in life sciences discipline or health care preferred. An equivalent combination of education, training, and experience may be accepted in lieu of a degree.

Role: Clinical Research Coordinator Role is 100% onsite, there is no opportunity for hybrid or remote work at this time Therapeutic Area: Pulmonology Employment Type: Position is a contract, project based support role - current contract duration is estimated to be 3 months, possibility for extension Schedule/ Shift: 40 hours a week M-F during daytime business hours Responsibilities/ Job Duties: This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization and Good Clinical Practices. Responsibilities - May be the sole coordinator or work in collaboration with a research nurse on studies, responsible for source documents, data collection, data entry, query resolution, triggering financial payments, study close out and liaison with the sponsor/CRO Contractor will focus support on recruitment activities including Chart Review, Phone Screening, Scheduling/Appointment Reminders, Contractor will assist with EDC Data Entry Contractor will also provide support with Source Document Storage, Regulatory Support Minimum Education and Experience Qualification Requirements: Minimum 1 year experience with clinical trial coordination required Minimum 1 year experience with participant screening and recruitment required Minimum 1 year experience with EDC Data entry and query resolution Minimum 1 year experience with Source Document Storage, and providing Regulatory Support Experience / knowledge related to immunology preferred Benefits: Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances) Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).) 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1) Short Term Disability Insurance Term Life Insurance Plan

Highlights $55,000 - $65,000 salary based on CRC experience! Great benefits including 401k with match Site that focuses on teamwork and high quality patient care Promote into Sr. CRC, Site Manager, Site Director and more! The Company Our client is a fast growing site network that currently has over 20 sites and constantly expanding! They focus on diversity in their trials including therapeutic areas: cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. Their sites conduct studies spanning Phases I-IV and they've been awarded for excellence in recruitment and recognized in the industry for retention, a best-in-class experience for patients and sponsors. Responsibilities As a CRC you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process! Conduct procedures such as vital signs, blood draws, EKGs, and bladder scans. Patient recruitment, enrollment, scheduling, and consent Lab procedures and shipments Maintain GCP and follow protocols Data management in EDC systems Overall coordination of the study Qualifications: 1+ year of experience working as a CRC in a non-academic setting 1+ year of experience with Sponsor backed clinical trials Phlebotomy experience Great if you have it: Bilingual/fluent in Spanish and English

Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Clinical Medicine Expert who would like to lend your expertise to train AI models? About the opportunity: Outlier is looking for talented Clinical Medicine Experts to help train generative artificial intelligence models This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you You may contribute your expertise by Assessing the factuality and relevance of domain-specific text produced by AI models Crafting and answering questions related to Clinical Medicine Evaluating and ranking domain-specific responses generated by AI models Examples of desirable expertise: A bachelor's or higher degree in Clinical Medicine or a related subject Experience working as a Clinical Medicine professional Ability to write clearly about concepts related to Clinical Medicine in fluent English Payment: Currently, pay rates for core project work by Clinical Medicine experts range from $25 to $45 per hour USD. Rates vary based on expertise, skills assessment, location, project need, and other factors. For example, higher rates may be offered to PhDs. For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply. Certain projects offer incentive payments. Please review the payment terms for each project.

We are currently looking for a *Full Time Clinical Coordinator *tojoin our enthusiastic team at Paul's Run. Paul's Run Retirement Community in Northeast Philadelphia has a reputation as one of the BEST senior health care providers. We take pride in our dedicated team members who support and care for our residents. We are family! *Shift / Schedule available*: * Full Time * 7:00am - 3:30pm * Monday - Friday * On-call weekends *Key job responsibilities include*: * Develop, in conjunction with the DON and NHA, QA monitors for the nursing department and review for pertinence and ability to implement procedures based on findings. * Complete monthly QA audits and actively participate in all QA/QAPI meetings. * Assist RNAC with MDS completion * Assist the DON with interviewing of potential new staff. * Participate in employee evaluations, clinical referrals, and disciplinary actions. * Ensure that staff are competent to handle residents assigned. * Assure supplies/equipment are in proper working order and available to the staff in order to provide good quality resident care. * Develop good relationships with Central Supply to monitor supplies and develop programs to adjust par levels as supply needs change. * Recommend new equipment and replacement equipment to meet the needs of the resident population being served. * Rent equipment and monitor its use assuring its return as soon as it is no longer needed. * Responsible for efficient and effective delivery of resident care in accordance with the mission of Paul's Run and as governed by State and Federal regulations. * Assist with reviewing, revising, and executing the Nursing service policies and procedures. *Education and Experience: * * Graduate from an accredited school of nursing; BSN preferred. * RNAC experience or willingness to learn * Current licensure as a registered nurse in the Commonwealth of Pennsylvania. * At least five years' experience as a nursing service manager with direct responsibility for nursing department, infection prevention, continuous quality improvement, MDS assessments, staff development/education. * Knowledge of PA DOH regulations, CDC guidelines, APIC, HIPAA, Risk Management, Corporate Compliance. * Knowledge of Federal and State regulations for LTC/skilled nursing. *Here is just some of the benefits of coming to work for Paul's Run.* * Take the 58 Bus to the front door * Industry leading paid time off * Outstanding Medical/Dental/Vision care * Company paid Life insurance and Long-term disability insurance * Retirement Savings Plan * Tuition Assistance Program *Click “Apply Now” to join a results oriented, quality first organization who listens!* Liberty Lutheran Family of Services is an Equal Opportunity Employer Job Type: Full-time Pay: From $87,000.00 per year Benefits: * 401(k) * Dental insurance * Employee assistance program * Free parking * Health insurance * Life insurance * Paid time off * Referral program * Tuition reimbursement * Vision insurance Medical Specialty: * Geriatrics Schedule: * 8 hour shift * Day shift * Monday to Friday * On call Experience: * nursing service manager: 5 years (Preferred) License/Certification: * RN (Required) Work Location: In person

Harmony Biosciences is recruiting for a Clinical Research Associate I in our Plymouth Meeting, PA location. In this role you will be responsible for independently monitoring clinical trial data in accordance with Good Clinical Practices (GCP), ICH, FDA, and internal standard operating procedures (SOPs). The CRA will conduct site visits to assess protocol and regulatory compliance while ensuring patient safety. This includes source document verification, regulatory document review and management, and drug accountability. Responsibilities include but are not limited to: Review the performance of the trial at designated sites. Ensure the rights and well-being of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the quality and integrity of the reported data on case report forms (CRFs) by careful and thorough source documentation review. Generate queries and assist sites with resolution. Track and follow serious adverse events (SAEs) ensuring timely reporting to appropriate entities. Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents. Reviews the completeness and quality of the investigator site file (ISF). Collects and reviews essential documents. Prepare accurate and timely trip reports while documenting visit findings. Assists in resolving any issues to ensure compliance. Escalating issues to the Study Manager as necessary. Maintain regular communication with sites. Conduct all aspects of site monitoring of clinical research studies according to Standard Operating Procedures, ICH Guidelines and GCP. Performs other related duties as assigned by management. Qualifications: Bachelor's Degree in a Science related discipline required 2+ years' experience in sponsor study clinical research monitoring, or 2+ years' progressive experience in supporting the conduct and oversight of clinical trial activities required within a CRO; Therapeutic experience in neurology, preferred Familiarity with scientific methods, research design and clinical trials Working knowledge of Microsoft Office Suite, Microsoft Projects a plus Physical demands and work environment: Travel is estimated to be 25% of the time, both domestic and international. Valid US passport is required or has the ability to obtain. While performing the duties of this job, the noise level in the work environment is usually quiet. The employee must occasionally lift and /or move more than 20 pounds. Specific vision abilities required by this job include: Close vision. Manual dexterity required to use computers, tablets, and cell phone. Continuous sitting for prolonged periods. What can Harmony offer you? Medical, Vision and Dental benefits the first of the month following start date Generous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings Plan Paid Parental leave Employee Stock Purchase Plan (ESPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunities A certified Great Place to Work for seven consecutive years based on our positive, values-based company culture Want to see our latest job opportunities? Follow us on LinkedIn ! Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit ************************** Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. #LI-Hybrid

The Clinical Research Associate is responsible for assisting with the management of clinical studies to ensure compliance with protocols and applicable regulations. They will provide operational support to the clinical trial team to ensure project milestones are delivered on time, with high quality, and in compliance with the ICH/GCP, regulatory authority's regulations/guidelines, and applicable SOPs. The Clinical Research Associate will support Clinical Trial Managers in all aspects of trial management, including: participation in CRO meetings, ensuring internal TMF documentation is filed appropriately, reviewing SOPs, as well as other activities as appropriate. Essential Duties and Responsibilities: Responsible for tracking start-up progress globally and tracking enrollment, study metrics and patient data. Update study dashboards, study trackers and other applicable study documents using EDC and other sources to provide regular updates on trial status. Assist Clinical Trial Managers with preparing documentation for trial-related agendas, meetings, data review and presentations as applicable. Conduct informed consent form and study budget review for global sites; escalate issues to Clinical Trial Manager and/or Legal as appropriate. Responsible for the review of monitoring reports and tracking of action items. Attend team and vendor meetings. Manage and provide updated contact lists and other study related documents to study vendors. Draft Vendor Management Plans as needed. Assist with IRT (interactive response technology) system set up for clinical sites. Assist with tracking of samples and documents with sites and vendors as needed. Manage clinical study documentation (trial master file and study related tracking); add meeting minutes and other documents to Sharepoint as needed. Schedule study related meetings. Serve as a point of contact between CRO personnel and Fore on study start-up and other activities. Assist with the creation and distribution of quarterly newsletters and other study-related documents. Interact with Data Management, Clinical Development and other cross-functional representatives as needed. Assist with preparation for investigators meetings, site communications/newsletters, and site training activities. Support systems and applications as needed. Contribute to internal data review. Education and/or Work Experience Requirements: BA/BS degree, preferably in scientific or healthcare related field. At least 2 years of experience in clinical research role, preferably in oncology. CRO and/or study start-up experience preferred. Experience in global clinical trials in the U.S. and European Union, with other geographies desired. Demonstratable advanced team facilitation skills that consistently foster effective brainstorming and decision making with both internal colleagues and vendors. Demonstratable ability to operate independently in an entrepreneurial environment. Excellent interpersonal skills and problem solving/decision making skills. Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company. Fore is an Equal Opportunity Employer. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

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

The Senior Research Associate, in collaboration with the Principal Investigators, 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; monitor data collection for accuracy; process informed consent paperwork; and ensure that study payment is processed and received in a timely fashion. Additional responsibilities include working independently to drive day-to-day research activities; monitoring and tracking expenditures; 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 four 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 analytical and problem solving skills, with strong attention to detail. *Demonstrated organizational and time management skills, along with the 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: *Experience with eDC database.

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.

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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.

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

This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires. Job Type: Full Time Sign on bonus Eligible: Yes Training: Full Orientation in addition to ongoing department training and study training. Qualifications * College degree in related health science or 2 years Clinical Research work experience. * Desire to work with patients Full Job Description Mid Atlantic Retina is one of the largest retina practices in the area, offering bonuses, top pay and growth opportunities for employees to not just work a job, but build a career. As a Research Coordinator, you will be responsible for coordinating all aspects of Mid Atlantic Retina's phase 1 through phase 4 clinical research trials. Benefits * 401(k) & Profit Sharing * Health Insurance * Dental Insurance * Vision Insurance * Life Insurance * Short & Long Term Disability * Paid Time Off * Bonuses Essential Functions * Maintains a solid understanding of objective (primary and secondary endpoint) and rational of study. * Obtains written informed consent and ensures all documentation of processes. * Maintains awareness of regulatory need for study and ensures completion of action items. * Reviews 1572 and delegation logs prior to start of study. * Provides guidance to ancillary staff (Photographer, OCT Tech, BCVA, Receptionist, unmasked personnel) to make sure protocol is properly completed and any action items are completed. Communicates with them proactively throughout the study. * Understands inclusion and exclusion criteria as they relate to study objectives, patient safety and retention of patients for valuable data. * Informs subjects of any study changes including risks and signs amended informed consents. * Collaborates with Screening Department in order to initiate a screening packet within the time frame for enrollment. * Determines required visits and protocol agendas. * Enrolls and retains patients in all assigned clinical trials. * Manages clients within protocol parameters to ensure patient safety and the collection of valuable data and keeping protocol violations to a minimum. * Completes clear, concise documentation of source documents following sample source SOPs to compliment data in CRFs in a timely manner. * Records all communication in source or regulatory file. * Communicates proactively with sponsors and CROs and assures all action items are completed in a timely manner. * Boosts enrollment by informing doctors of study details, competing chart reviews and utilizing supplemental material. * Responds to referrals within 24 hours. * Completes all DCFs and ECRFs in a timely manner (within 7 days of visit). * Works with CRAs, Medical Monitors and/or other personnel who are instrumental in answering questions, as well as building a professional rapport that can help in the successful undertaking and completion of study. * Transports clinical specimens to lab or arranges for specimen pick up. * Follows all FDA/GCP regulations. * Responsible for all regulations for assigned clinical trials. * Cross-covers for other Coordinators as needed. * Telephone screening of patients. * Regular and predictable attendance required. * Works overtime as needed. * Travels as needed. * Performs other duties as assigned. Physical & Cognitive Demands * This position is very active and requires standing and walking all day in order to get patients and bring them to rooms, assist physicians and rotate assignments with other staff. * While performing the duties of this job, the employee is regularly required to talk, communicate verbally in front of groups, one to one and over the telephone and in email. * Occasional bending, kneeling, stooping, and crouching. * Lift or move objects weighing over 15 pounds as needed. * Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Working environment in exam rooms is often in moderate light. * Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina. * Ability to raise dominant arm above shoulder height to administer drops. * Use senses to observe and examine patients, paying attention to detail. * Works with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying and recording, storing and retrieving information. * Sustain physical contact with another person in order to guide them due to their diminished vision.

Study Setup and Specimen Coordinator Job Title: Study Setup and Specimen Coordinator Location: Exton, PA/on-site 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.

The Center for Healthcare Delivery Science (CHDS) at Nemours Children's Health is seeking a full-time Clinical Research Coordinator (CRC). Bilingual (English/Spanish) communication skills are preferred. The is based at Nemours Children's Hospital - Delaware in Wilmington. The CHDS is a research center across the Nemours enterprise. Anne E. Kazak, Ph.D., ABPP is the enterprise director, Melissa A. Alderfer, PhD is the Center Director in Delaware and Susana Patton, PhD is the Center Director in Florida. The CHDS includes 18 investigators that study ways to improve health care, health equity, and health and wellness beyond medicine for youth and their families. Research projects span a variety of medical conditions (e.g., diabetes, cancer, cardiac conditions, obesity, sickle cell disease, cystic fibrosis, pain) and other health-related challenges (homelessness, maternal post-partum depression). The CRC will be responsible for coordinating, implementing and completing research functions associated with studies in the CHDS, many of which recruit Spanish-speaking families. Essential CRC duties include coordinating IRB submissions, recruiting study participants, obtaining informed consent, interacting with youth, young adults and parents related to research projects, scheduling and conducting study procedures, collecting and recording study data, organizing participant payments, maintaining study records, participating in data collection and analysis, and the preparation of scientific presentations, manuscripts, reports, and grants. Position Requirements: Minimum of a bachelor's degree in psychology, pre-med, public health, or related. Must be able to effectively use Microsoft computer software, SPSS, and REDCap. Must be able to coordinate and establish priorities among diverse tasks. Previous research experience, including qualitative interviewing strongly preferred Bilingual (English/Spanish) communication skills preferred.

Clinical Research Coordinator 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 oncology 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. 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;

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. 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. 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) _