Clinical research associate jobs in Levittown, PA - 182 jobs

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. The CRA Trainer will play a critical role in developing and delivering global training programs for Clinical Research Associates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinical research experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials. Responsibilities * Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education). * Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards. * Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance. * Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight. * Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability. * Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed. * Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions. * Stay current with regulatory updates and industry best practices to ensure training content remains relevant. * Support development of study-specific training for CRAs and site personnel. * Maintain documentation of all training activities for audit readiness. Qualifications * Bachelor's degree in health sciences or related field. * Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise. * Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address. * Excellent verbal and written communication skills; strong presentation and facilitation abilities. * In-depth knowledge of ICH-GCP guidelines and clinical trial processes. * Critical thinking for troubleshooting monitoring challenges * Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO). * Strong organizational and time management skills; ability to manage multiple priorities. * Experience in developing training materials and delivering educational programs preferred. * Ability to travel as needed (up to 25%). Compensation and Benefits: The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. The CRA Trainer will play a critical role in developing and delivering global training programs for Clinical Research Associates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinical research experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials. Responsibilities Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education). Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards. Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance. Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight. Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability. Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed. Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions. Stay current with regulatory updates and industry best practices to ensure training content remains relevant. Support development of study-specific training for CRAs and site personnel. Maintain documentation of all training activities for audit readiness. Qualifications Bachelor's degree in health sciences or related field. Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise. Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address. Excellent verbal and written communication skills; strong presentation and facilitation abilities. In-depth knowledge of ICH-GCP guidelines and clinical trial processes. Critical thinking for troubleshooting monitoring challenges Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO). Strong organizational and time management skills; ability to manage multiple priorities. Experience in developing training materials and delivering educational programs preferred. Ability to travel as needed (up to 25%). Compensation and Benefits: The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Job Description About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is “inspection ready” contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license 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 maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. 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. 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 or submit a request here 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. Are you a current ICON Employee? Please click here to apply

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What You Will Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN Eligible to work in United States without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Pennsylvania near major HUB airports to support efficient regional travel. 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 maximize 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 site to read more about the benefits ICON offers. 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. 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 or submit a request here. 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. Are you a current ICON Employee? Please click here to apply

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What You Will Be Doing:** + Serve as the primary point of contact between investigational sites and the sponsor + Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH-GCP, SOPs, and regulations + Maintain up-to-date documentation in CTMS and eTMF systems + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting + Support subject recruitment and retention efforts at the site level + Oversee drug accountability and ensure proper storage, return, or destruction + Resolve data queries and drive timely, high-quality data entry + Document site progress and escalate risks or issues to the clinical team + Assist in tracking site budgets and ensuring timely site payments (as applicable) + Collaborate with cross-functional partners including CTAs, LTMs, and CTMs **You are:** + A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN + Eligible to work in United States without visa sponsorship + A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry + Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology + Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF + A clear communicator, problem-solver, and collaborative team player + Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Pennsylvania near major HUB airports to support efficient regional travel. **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 maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. 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. 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 or submit a request here (****************************************************** 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. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

Clinical Research Associate Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines. Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics. In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers. How You'll Add Value * Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, and electronic or binder preparation for distribution. * Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review * Prepare CST meeting minutes. * Act as a resource for the clinical sites and research monitors for the trial. * Assist with training of site staff who are working on the study. * Collect regulatory documentation and ensure accuracy. Record the receipt of all key study documentation and contact site regarding missing records. * Review various study-related tracking systems to determine and report the status of clinical trial documents. * Collect outstanding documents by contacting the clinical trial sites or working with the field monitors. * Send notifications to the clinical trial sites regarding their IRB renewal dates. * Maintain and audit all study-related files in compliance with department standard operating procedures. * Assist with the follow-up and resolution of noted observations on audit and monitoring reports. * Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories. * Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies. * Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, and Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings. * Review and approve Site Qualification Reports for new clinical trial sites * Train users on the EDC/case report forms and other systems that may be used (i.e., electronic regulatory Binders). * Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement. Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment. What You're Bringing with You * 1-2 years of clinical research experience with a bachelor's degree and/or * 4 years of clinical research experience with professional certification (CCRP, ACRP) * Experience with communicating with hospital administrators, research nurses, and study coordinators. * Working knowledge of FDA regulations, Good Clinical Practices (GCPs), and all applicable state, local, and federal regulatory requirements. * Experience with IBM EDC, ClinPlus CTMS, Florence e-Binders, Egnyte, and/or other eRegulatory solutions. * Medical device and/or heart failure clinical trials experience preferred. * Bachelor's degree in life sciences or related field preferred or equivalent work experience. Our commitment to you Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds. Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around the diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference. Annual Base Salary Range: $ 60,000 - $ 75,000 * Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics. * Paid Vacation, floating holidays, and sick time. * Paid Holidays * 401k Match (up to 6%) * Annual bonus eligibility Unless specifically indicated communicated otherwise in writing, all employees are "at-will" employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment. Equal Opportunity Employer Statement: Impulse Dynamics is an equal opportunity employer. Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.

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

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 Description The primary responsibility of the Research Assistant is to assist the Research Unit in conducting clinical trials. The Research Assistant is responsible for collecting and processing clinical data and providing administrative support to the Research Team. Essential Functions Assists the Research Coordinator with the conduction of clinical trials and patient flow. Accurately collects clinical data on research patients. Maintains and updates information in data base. Assists Coordinator with monitor preparation and follows up on any action items and query resolution. Assists in trial recruitment (chart reviews, communicating with Physicians, database reports). Aides in regulatory submissions and assists Regulatory Specialist as needed. Assists Fellows and Physicians on research projects and data collection. Maintains temperature logs for drug closet, freezer and refrigerator. Reports any deviations. Checks and replaces batteries as needed. Performs administrative duties for the Research Department including answering phones, scheduling appointments, and ordering supplies. Telephone screening of patients. Screens research subjects with Coordinator assistance. Regular and predictable on-site attendance required. Works overtime as needed. Travels to other MAR locations as needed. Performs other duties as assigned. Supervisory Responsibility This position has no direct supervisory responsibilities. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical and Cognitive Demands The physical and cognitive demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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. Using words to communicate ideas, reading with comprehension, writing reports or other documentation, teaching or training patients. Sustain physical contact with another person in order to guide them due to their diminished vision. Ability to follow through on plans or instructions. Travel Willingness to travel is required. Required Education and Experience 1 year clinical research experience or ophthalmic experience. Job Posted by ApplicantPro

Job Details Works under direct supervision and assists research coordinators with organizing, gathering and compiling clinical research data. Tracks and maintains credentialing documentation for staff and all researchers participating in clinical trials in accordance with IRB regulations. May provide clerical and technical support to ensure adherence to research protocols and quality of information received Job Description Performs a variety of research, data base and clerical duties in support of clinical trials to assist investigators in organizing, gathering and compiling clinical research data. Organizes and maintains documentation required for clinical trial(s). Informs Principal Investigator and/or designated individual on any issues concerning patient's response to treatment/medication/ any adverse effects overall to patients. Assists Principal Investigator with IRB filings and annual reviews. May assist in the enrollment of human subjects. Education: Minimum High School Diploma or equivalent. AND Experience: Experience in research or clinical setting preferred. Work Shift Workday Day (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson University Primary Location Address 909 Walnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here

Why Join Us? For us, what matters most is excellence. We are caring professionals, people who live, work and dedicate themselves to the communities within New Jersey and Pennsylvania. As such, we strive to provide a sanctuary of excellence, precision, thoroughness and genuine compassion. We also take a whole-person approach to patient care and treatment, tailoring all that we do around their unique needs. And we do all we can for patients, going the extra mile to see that they're supported, informed and getting the one-on-one care and service they deserve. Job Description: As an Oncology Clinical Research Assistant (CRA), you will be assisting team members at Astera Cancer Care on recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position. Responsibilities Include: Assisting Clinical Research Coordinator (CRC) to ensure that clinical research activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs Assisting CRC on the coordination of tests and visits for patients and maximizing work efficiency and productivity. Assisting Regulatory Specialist (RS) on IRB submissions and interact to maintain regulatory documents and administrative files for each protocol. Assisting CRC on confirming patient's eligibility into clinical trials. Assisting Clinical Data Coordinator (CDC) and RS on maintaining patient and regulatory research records. Confer with all members of the clinical team to confirm appropriateness and timeliness of tests. Collect follow-up data on patient's post-treatment as required by the protocol. Assisting CDC on entering research data into a centralized database as per protocol requirements. Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs. Qualifications: A Bachelor's degree preferred. Experience with Microsoft applications. Able to travel between offices within the offices in Northeast Jersey area. Excellent communication skills. Excellent time management skills.

About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit s team is inspired to touch and help change lives through Summit s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data Creation and development of study trackers Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. Responsible for reviewing assigned study related plans, processes, agreements, and guidelines Following and implementing assigned study related plans, processes, agreements, and guidelines Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met Reviews and approves essential document packages to enable timely site activations. Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate All other duties as assigned Experience, Education and Specialized Knowledge and Skills: Bachelor s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred A minimum of 3+ years of clinical research experience in conducting clinical trials Prior phase II or III experience required A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process Experience with clinical studies oncology and / or rare diseases a plus Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) Tenacity to work in a fast-paced team environment Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships Ability to successfully engage and work collaboratively with global team members/colleagues Ability to support building and delivery of patient enrolment strategies Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. Ability to review and assess clinical data Possesses excellent planning, time management & coordination skills. Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit s Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.

Job DescriptionSystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. We are seeking a motivated Clinical Research Associate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements. This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers. Responsibilities Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits. Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries. Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts. Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders). Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned. Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy. Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level. Qualifications Bachelor's degree in health sciences or related field. 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC). Exposure to oncology trials. Knowledge of ICH-GCP guidelines and regulatory requirements. Strong organizational skills, attention to detail, and ability to work both independently and within a team. Willingness to travel regionally (approx. 50%-75%). Preferred 1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role. Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance. Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight. Compensation and Benefits: The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply. Powered by JazzHR jZ3XHqOc1X

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. We are seeking a motivated Clinical Research Associate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements. This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers. Responsibilities * Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits. * Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries. * Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts. * Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders). * Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned. * Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy. * Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level. Qualifications * Bachelor's degree in health sciences or related field. * 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC). * Exposure to oncology trials. * Knowledge of ICH-GCP guidelines and regulatory requirements. * Strong organizational skills, attention to detail, and ability to work both independently and within a team. * Willingness to travel regionally (approx. 50%-75%). Preferred * 1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role. * Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance. * Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight. Compensation and Benefits: The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role. SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What You Will Be Doing:** + Serve as the primary point of contact between investigational sites and the sponsor + Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out + Ensure site compliance with ICH-GCP, SOPs, and regulations + Maintain up-to-date documentation in CTMS and eTMF systems + Support and track site staff training and maintain compliance records + Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting + Support subject recruitment and retention efforts at the site level + Oversee drug accountability and ensure proper storage, return, or destruction + Resolve data queries and drive timely, high-quality data entry + Document site progress and escalate risks or issues to the clinical team + Assist in tracking site budgets and ensuring timely site payments (as applicable) + Collaborate with cross-functional partners including CTAs, LTMs, and CTMs **You are:** + A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN + Eligible to work in United States without visa sponsorship + A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry + Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology + Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF + A clear communicator, problem-solver, and collaborative team player + Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in New Jersey near major HUB airports to support efficient regional travel **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 maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. 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. 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 or submit a request here (****************************************************** 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. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

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

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 Description The primary responsibility of the Research Assistant is to assist the Research Unit in conducting clinical trials. The Research Assistant is responsible for collecting and processing clinical data and providing administrative support to the Research Team. Essential Functions * Assists the Research Coordinator with the conduction of clinical trials and patient flow. * Accurately collects clinical data on research patients. Maintains and updates information in data base. * Assists Coordinator with monitor preparation and follows up on any action items and query resolution. * Assists in trial recruitment (chart reviews, communicating with Physicians, database reports). * Aides in regulatory submissions and assists Regulatory Specialist as needed. * Assists Fellows and Physicians on research projects and data collection. * Maintains temperature logs for drug closet, freezer and refrigerator. Reports any deviations. Checks and replaces batteries as needed. * Performs administrative duties for the Research Department including answering phones, scheduling appointments, and ordering supplies. * Telephone screening of patients. * Screens research subjects with Coordinator assistance. * Regular and predictable on-site attendance required. * Works overtime as needed. * Travels to other MAR locations as needed. * Performs other duties as assigned. Supervisory Responsibility This position has no direct supervisory responsibilities. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical and Cognitive Demands The physical and cognitive demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. * 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. * Using words to communicate ideas, reading with comprehension, writing reports or other documentation, teaching or training patients. * Sustain physical contact with another person in order to guide them due to their diminished vision. * Ability to follow through on plans or instructions. Travel Willingness to travel is required. Required Education and Experience * 1 year clinical research experience or ophthalmic experience.