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  • Clinical Research Coordinator - Drug Studies - 94053

    Swoon 4.3company rating

    Clinical research associate job in Philadelphia, PA

    I'm working with a university, ranked in the top 100 of National Universities, to hire a Clinical Research Coordinator to their drug studies team. Contract Duration: 3 month contract with high potential to convert Pay Rate: $28-34/hr About this role: Coordinate recruitment and enrollment of research participants Establish and maintain databases of subjects Schedule and conduct study visits Collect and enter data; register subjects and study visits in OnCore Perform Epic research billing review Maintain an up to date regulatory binder Schedule and attend sponsor visits and prepare and submit IRB paperwork to ensure compliance with IRB regulations. Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience Experience with drug studies is nice to have Knowledge of FDA, IRB, Pennsylvania and related regulations Prior experience with IRB submissions both local and central is nice to have Prior Electronic Data Capture (eDC) data entry skills is nice to have Strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants Interested? Apply now!
    $28-34 hourly 3d ago
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  • Clinical Research Associate (Start Up) Multi TA - Irvine, CA

    Icon Clinical Research

    Clinical research associate job in Blue Bell, PA

    Clinical Research Associate (SOAR) Multi TA - Texas 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 will you be doing?** + Works on multiple trials within the Cross Therapeutic areas - Start up focus + Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. + Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. + Build strong relationships with site personnel to facilitate a smooth onboarding process. + Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). + Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. + Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. + Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. + Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. + Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. + Proactively identify and address any issues that may delay study initiation or affect trial deliverables. + Maintain precise documentation to ensure readiness for inspections. + Support sites during the activation phase until they achieve "Green Light" status for site opening. + Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. + Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. **What do you need to have?** + Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences + Must be located in Irvine, California area, near a major airport. + Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials + Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical 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. + 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 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. Salary range: $91,336.00-$114,170.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here (****************************************************** to apply
    $91.3k-114.2k yearly 11d ago
  • Clinical Research Associate II

    Allen Spolden

    Clinical research associate job in Philadelphia, PA

    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
    $56k-88k yearly est. 60d+ ago
  • Clinical Research Associate - Oncology - Pennsylvania

    Icon Central Laboratories

    Clinical research associate job in Philadelphia, PA

    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
    $56k-88k yearly est. Auto-Apply 6d ago
  • Clinical Research Associate - Oncology - Pennsylvania

    Ire

    Clinical research associate job in Philadelphia, PA

    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
    $56k-88k yearly est. Auto-Apply 5d ago
  • Clinical Research Associate II

    Icon Plc 4.8company rating

    Clinical research associate job in Blue Bell, PA

    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
    $48k-70k yearly est. 8d ago
  • Clinical Trials-Project Coordinator

    Mindlance 4.6company rating

    Clinical research associate job in Collegeville, PA

    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.
    $50k-71k yearly est. 1d ago
  • Clinical Research Coordinator Senior (Neurosurgery)

    Kennedy Medical Group, Practice, PC

    Clinical research associate job in Philadelphia, PA

    Job Details Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Runs portions of clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and/or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups. This position is in the Department of Neurosurgery on the Clinical Research team, supporting multiple Neurosurgical divisions with both interventional and observational industry sponsored and investigator-initiated studies. This position requires coordinators to participate in an on-call rotation for studies requiring off-hours enrollment. Job Description Oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Trains and supervises research staff on the proper procedures for conducting a clinical trial per GCP. Prepares and submits all materials for the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol to ensure compliance in a timely fashion. Maintains accurate subject log, tracks expenses, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies. Performs regular quality control assessments to ensure that clinical trial data is collected and stored per GCP. Organizes and maintains documentation of all patient data. Designs electronic capture databases, if appropriate, and manage all the data collected. May provide clerical and technical support to ensure adherence to research protocols and quality of information received. Participate in on-call studies in the department of Neurosurgery, where enrollment may occur off-hours or over weekends. High School Diploma or equivalent and SoCRA certification and 6 years of clinical research experience or Bachelor's degree and 2 years of clinical research experience or Master's Degree and 1 year clinical research experience. Work Shift Workday Day (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson University Primary Location Address 901 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
    $48k-75k yearly est. Auto-Apply 23d ago
  • Clinical Research Assistant

    Mid Atlantic Retina 3.9company rating

    Clinical research associate job in Cherry Hill, NJ

    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.
    $44k-59k yearly est. 54d ago
  • Clinical Research Coordinator

    Actalent

    Clinical research associate job in Philadelphia, PA

    Job Title: Clinical Research CoordinatorJob Description Join a dynamic team to support cutting-edge oncology studies backed by pharmaceutical sponsors. As a Clinical Research Coordinator, you will play a pivotal role in advancing clinical trials and contributing to innovative research efforts. Responsibilities * Recruit, screen, and enroll subjects into clinical trials. * Explain the informed consent process to participants. * Document adverse events in compliance with study protocols. * Collect and manage study documents, protocols, regulatory documents, informed consents, case report forms, and source documents. * Prepare and submit applications to the Institutional Review Board (IRB). Essential Skills * Experience with in-hospital clinical research. * Minimum of 2+ years of clinical research experience. * Proficiency in adverse event reporting. * Strong communication and writing skills. * Knowledge of IRB and human research protection regulations. Additional Skills & Qualifications * Bachelor's degree (BA/BS) preferred. * Experience with patient recruitment and consenting. * Familiarity with oncology clinical trials and GCP guidelines. Work Environment This role operates within a combination of office and hospital/outpatient surgery settings. It is a fast-paced and high-volume work environment involving industry and investigator studies. After an initial three-month period of five days on-site, the position offers a hybrid work schedule of three days on-site and two days remote per week. You will be working at one of the most prestigious academic research institutes, equipped with state-of-the-art facilities, and engage in high-profile studies with renowned sponsors. Job Type & Location This is a Contract to Hire position based out of Philadelphia, PA. Pay and Benefits The pay range for this position is $28.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Feb 3, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $28-31.3 hourly 7d ago
  • Clinical Research Coordinator in Darby, PA

    Panoramic Health

    Clinical research associate job in Darby, PA

    Clinical Research Coordinator I will perform delegated duties such as protocol required visit procedures, administering questionnaires and subject material, administering, and dispensing medication, adhering to regulatory guidelines, and participating in subject recruitment efforts, under the oversight of the study Principal Investigator. The Clinical Research Coordinator needs to engage with the Principal Investigators, pharmaceutical companies (Sponsors) and contract research organizations (monitors) as well as the research subjects. Responsibilities include: Read and understand assigned research protocols. Prescreen patients. Train site staff on study purpose, record attendance. Evaluate resources needed and on-hand to appropriately deploy the study. Drive enrollment to meet contractual targets: Using the EMR, screen for eligible patients for discussion and qualification by the Principal Investigator. Obtain and document informed consent per ICH/GCP and site SOPs. Timely, clean data entry according to ALCOA principle (“Attributable, Legible, Contemporaneous, Original and Accurate”). Prepare for monitoring visits: All Source Documents organized and readily available. All outstanding items from prior monitoring visit are resolved. No open queries from prior visit. Temperature and accountability logs readily available. Ongoing Study oversight and management: Plan subject visits according to protocol specific visit schedule. No protocol deviations due to out of window procedures. Communication with location administration to make sure space and other resources are available as needed. Reporting of Adverse and Serious Adverse Events to IRB and Sponsor in accordance with reporting guidelines. Dispensing/collecting study medication and providing accurate Investigational Product accountability. Collecting and processing subject laboratory specimens according to protocol. Completing case report forms (CRFs) and other patient tracking information (either electronic or manual) accurately and on a timely basis as assigned. Maintaining a thorough understanding of all data collection instruments and collecting data accurately and according to protocol. Perform other duties and responsibilities as required, assigned, or requested. Qualifications: Bachelors' degree required; Nursing or Health Science preferred. Bilingual preferred (Spanish). Minimum 2 years' experience as a clinical research coordinator. Therapeutic area experience in CKD, nephrology, or vascular access a plus. Knowledge of and adherence to Good Clinical Practice (GCP), IATA and FDA regulations. Must be able to do basic clinical procedures such as: blood work, vitals, height, weight, etc. Must be able to do an ECG. Travel to Investigator meetings or other study locations is expected with this position. Travel might be outside the local area and overnight.
    $42k-62k yearly est. 5d ago
  • Clinical Research Coordinator

    Vitalief

    Clinical research associate job in Philadelphia, PA

    Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced Clinical Research Coordinator (CRC) to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading academic research center in Philadelphia, managing high-priority interventional clinical studies across multiple therapeutic areas. WHY VITALIEF? Contribute to advancing scientific discoveries that improve patient lives. PEOPLE FIRST culture with opportunities for growth and innovation. Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans. Hybrid schedule: 4 days on-site (Philadelphia), 1 day remote weekly. Market-competitive salary, commensurate with experience. Responsibilities: Under the direction of the Director and Clinical Investigators, this role will support the planning, implementation, and execution of multiple concurrent clinical research studies, including NIH-sponsored, industry-sponsored, and investigator-initiated trials. Work independently managing day-to-day research activities from study start-up to close-out. Act as liaison between investigators, research teams, and sponsors to ensure timely delivery of services. Coordinate patient recruitment, enrollment, consent, and retention. Schedule and conduct participant study visits, maintain databases, and ensure accurate data collection/entry. Manage regulatory binders, IRB submissions, and compliance with FDA, IRB, and GCP guidelines. Monitor safety events, prepare reports, and support sponsor/audit visits. Maintain study records (OnCore, Epic, ClinicalTrials.gov) and oversee research billing reviews. Assess and report study patients appropriately for serious/unexpected adverse events (SAEs). Consistently meet or exceed enrollment targets. Required Skills: Bachelor's degree (healthcare or related field preferred). Minimum of two (2) to four (4) years of clinical research coordination experience (academic/institutional site experience preferred). Strong knowledge of GCP, FDA, and IRB regulations. Experience in patient recruitment/retention, IRB submissions, data management, and SAE reporting. Proficiency with Electronic Health Records (Epic preferred) and Clinical Trial Management Systems (OnCore preferred). Strong Microsoft Office skills (Word, Excel, PowerPoint). Excellent written and verbal communication skills; ability to work effectively with diverse populations including faculty, staff, sponsors, and research participants. Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment. Proactive, adaptable, and self-motivated with a positive, “can do” attitude. Compassionate, professional demeanor with strong patient interaction skills. Phlebotomy certification (or willingness to train) preferred. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR MV2N0LilOS
    $42k-62k yearly est. 13d ago
  • Clinical Research Coordinator-Pool

    Temple, Inc. 4.3company rating

    Clinical research associate job in Philadelphia, PA

    Clinical Research Coordinator-Pool25003464Description Temple University's Clinical Research Department is searching for a Clinical Research Coordinator to join our team!Become a part of the Temple family and you will have access to the following: Full medical, dental, vision coverage Paid time off 11 Paid Holidays Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE A generous retirement plan and so much more!Salary Grade: T25Learn more about the “T” salary structure Salary Range: $50,000 to $55,000A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details. Job Details:*This is a grant-funded position*This position requires the following background checks: Cash Handling *Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator. *Hybrid work options may be considered depending on study and departmental needs. Position Summary: The Clinical Research Coordinator works under the leadership of the Principal Investigator and/or other Research Staff and is responsible for specific research tasks associated with clinical research projects or clinical trials, ensuring high-quality data collection, regulatory compliance, and seamless study operations. As a Clinical Research Coordinator, you will also have the opportunity to advance your career through our structured step increase program. We also recognize and reward professional development. Coordinators who successfully earn industry-recognized certifications, such as the Certified Clinical Research Professional (CCRP ) through SOCRA or the Certified Clinical Research Coordinator (CCRC ) through ACRP, may qualify for advancement sooner. At Temple University's Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine. Required Education and Experience: Bachelor's degree in a life science or other health professions field*A minimum of three years of related experience *An equivalent combination of education and experience may be considered. Responsibilities:The Clinical Research Coordinator performs study coordination tasks independently, following established protocols and procedures. The coordinator makes decisions that require interpretation of policies, procedures, or instructions to ensure accurate and compliant execution of clinical research projects. *Oversees the day-to-day activities of all assigned research projects and clinical trials. *Screens, tracks, and enrolls patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University. Schedule and attend sponsor visits. *Enrolls human subjects for clinical trials. Obtains informed consent, schedules subjects for visits, performs clinical assessments and collects and enters study data. *Performs various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data. *Organizes and maintains documentation required for clinical trials and/or other research projects. Maintains up-to-date regulatory binders. *Inform the Principal Investigator or designated individual about any issues regarding patient responses to treatment, medication, or adverse effects. *May submit IRB paperwork to ensure compliance with IRB regulations. *Assist the Principal Investigator with Institutional Review Board (IRB) filings and annual reviews. *Offer clerical and technical support to ensure adherence to research protocols and maintain the quality of information received. *May prepare, review, and submit IRB and regulatory paperwork, ensuring full compliance with institutional, FDA, IRB, and state requirements; supports complex filings and amendments. Adheres with FDA, IRB, Pennsylvania, and other applicable regulations. *Performs other duties as assigned*May present project updates at clinical research meetings and/or assist with grant or manuscript preparation. Performs other duties as assigned Required Skills and Abilities:*Demonstrated computer skills, and proficiency with MS Office Suite software programs. *Aptitude in professionalism*Excellent written and oral communications skills*Ability to work evenings/weekends hours as needed. *Knowledge of medical terminology*Able to resolve problems/issues*Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants*Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously. *Knowledge of IRB and human subject protection*Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines. *Ability to travel to off-site locations that may not be accessible via public transportation. *Strong time management skills Preferred Skills and Abilities:*Prior experience with IRB submissions. *Prior experience processing and shipping biological samples. *Prior phlebotomy certification or willing to learn. *Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders. *Prior Electronic Data Capture (eDC) data entry skills. *Prior research experience in a healthcare setting. *Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Go here to review. You may request a copy of the report by calling Temple University's Department of Public Safety at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science HallWork Locations: Kresge Science Hall Schedule: Full-time Job Posting: Dec 23, 2025, 4:24:17 PM
    $50k-55k yearly Auto-Apply 3h ago
  • Clinical Research Coordinator

    Foot and Ankle Center 4.0company rating

    Clinical research associate job in Bryn Mawr, PA

    Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance The CRC will work at the Foot & Ankle Center in Bryn Mawr, Pennsylvania. The center is dedicated to conducting basic, clinical, and translational research on podiatric conditions and diseases to advance foot and ankle health and treatment options. The CRC will focus on research initiatives related to podiatric conditions, treatments, and interventions. This includes research in foot and ankle health, diabetic foot care, sports injuries, and congenital podiatric abnormalities. The role will involve working with a multidisciplinary team committed to advancing podiatric care through research, education, and quality improvement initiatives. The Clinical Research Coordinator will be a key member of the Research Team working closely with the Principal Investigator in coordinating clinical, behavioral, and community-engaged research to improve podiatric health outcomes. Under the direction of the Principal Investigator(s), Co-Investigators, and Research Manager, the Clinical Research Coordinator will perform various research duties for multiple research and quality improvement projects. Core responsibilities: · Support IRB submissions and regulatory filings · Adhere to IRB-approved protocols. · Coordinate protocol-related research procedures, study visits, and follow-up care. · Participate in the informed consent process of study subjects. · Screen, recruit, and enroll patients/research participants. · Support the safety of clinical research patients/research participants. · Maintain study source documents. · Under the supervision of PI, report adverse events. · Understand Good Clinical Practice (GCP) and regulatory compliance. · Educate subjects and families on protocol, study interventions, etc. · Comply with institutional policies, standard operating procedures (SOPs), guidelines, HIPAA, and management of confidential materials. · Comply with federal, state, and sponsor policies. Related responsibilities: · Complete case report forms (paper & electronic data capture) and address queries. · Submit documents to regulatory authorities (e.g., IRB, FDA) and/or review/monitoring boards (e.g., DSMB, independent safety officer). · Facilitate pre-study, site qualification, study initiation, and monitoring visits as appropriate. · Facilitate study close-out activities as appropriate. · Collect, process, and ship samples as applicable to the protocol. · Schedule subject visits and procedures. · Retain records/archive documents after study closeout. Education Qualifications: · Bachelor's Degree preferred. · Phlebotomy and/or Lab skills (MST, MSLT, etc) Experience Qualifications: · At least three (3) years of clinical research-related experience required. · Prior work in a medical clinic Compensation: $65,000.00 - $70,000.00 per year At Pace Foot and Ankle Centers, PLLC you are our most valuable asset! Our healthcare team is dedicated to the art and science of advanced foot and ankle treatments. Medicine and surgery are constantly evolving, and our physicians strive to stay current. Our goal is to incorporate our extensive training and knowledge into a rewarding healthcare experience. We value communication and teaching where our patients, who range from pediatric to geriatric, and their families are active participants in making decisions regarding their health and wellness. This business is independently owned and operated by the business owner. Your application will go directly to the business owner, and all hiring decisions will be made by the management of this business. All inquiries about employment at this business should be made directly to the business location, and not to PACE: Foot and Ankle Centers Corporate.
    $65k-70k yearly Auto-Apply 49d ago
  • Clinical Research Associate 1

    Allen Spolden

    Clinical research associate job in Philadelphia, PA

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K
    $56k-88k yearly est. 60d+ ago
  • Clinical Research Associate - Oncology - Pennsylvania

    Icon Clinical Research

    Clinical research associate job in Philadelphia, PA

    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
    $56k-88k yearly est. 4d ago
  • Clinical Study Manager

    Icon Plc 4.8company rating

    Clinical research associate job in Blue Bell, PA

    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 Project Manager to join our diverse and dynamic team. Working as a Clinical Study Manager, exclusively assigned to a Pharmaceutical Company, you will lead or support close out activities within the RATIO team (R&D Asset Transition and Integration Office). In close collaboration with the Clinical Operations Program Lead (COPL) and the Clinical Operations Manager (COM) (if applicable): * You will support or oversee the execution of select study/ies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget. * Oversee Strategic Partners and/or other CROs and other vendors to meet the Company's obligations described in ICH-GCP and the Company business objectives. What You Will Be Doing: Accountable for planning and operational strategy and execution for assigned clinical trials * Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents * Challenges study team to ensure operational feasibility, inclusive of patient and site burden * Supports budget development and ensures impacts are adequately addressed * Participates in country and site feasibility/selection process, with a focus on providing country insights, alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy * Develops and manages study timelines * Challenges study team to ensure timelines meet the needs of the clinical development plan * Ensures new team members and vendors are appropriately onboarded * Identifies and oversees trial risk and mitigation * Leader of the cross functional study team * Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly * Supports/reviews study budget planning and management and accountable for external spend related to study execution. Works closely with COM (if applicable) and COPL, Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to COM and COPL; serve as escalation point for all vendors managed by Strategic Partner and/or other CROs * Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted; Specific areas of sponsor oversight include, but are not limited to: * Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring * Conduct Oversight Monitoring Visits, as applicable * Review and endorsement of relevant study plans, as applicable * Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes * Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study * Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies * Review and ownership of trial operational data (e.g. CTMS) * Review and provide oversight of internal trial reports * In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR * Support data review for database lock and CSR writing and review (including appendices) * Collect/review/File study documents in support of the trial master file (TMF) * Collect/review/File study documents in support of the regulatory filing * Responsible for overseeing study financial reconciliation * Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections. * Site relationship management * Review and provide oversight of trial audits * Proper and timely follow up to audit findings and CAPAs * Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations Your Profile: Education: Bachelor's Degree or international equivalent required; Life Sciences preferred. Skills: * Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required * Demonstrated successful experience in project/program management and matrix leadership. Including timeline/budget management and risk identification and management * Works independently and is highly organized * Good communication skills * Excellent teamwork, organizational, interpersonal, and problem-solving skills, including experience with Leading cross-functional teams, vendor selection and oversight * Experience managing recruitment challenges and boosting enrollment * Fluent business English (oral and written) Experience: 5+ years' experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA). Experience should include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous. Advanced degree(s) (e.g. Master or Doctorate) and relevant training or experience (e.g. fellowship, internships, etc.) may be considered to supplement experience requirements. 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
    $53k-79k yearly est. 20d ago
  • Clinical Trials-Project Coordinator

    Mindlance 4.6company rating

    Clinical research associate job in Collegeville, PA

    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.
    $50k-71k yearly est. 60d+ ago
  • Clinical Research Assistant - Neurosurgery

    Kennedy Medical Group, Practice, PC

    Clinical research associate job in Philadelphia, PA

    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
    $34k-50k yearly est. Auto-Apply 9d ago
  • CLINICAL RESEARCH COORDINATOR

    Foot and Ankle Center 4.0company rating

    Clinical research associate job in Bryn Mawr, PA

    Job DescriptionBenefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance The CRC will work at the Foot & Ankle Center in Bryn Mawr, Pennsylvania. The center is dedicated to conducting basic, clinical, and translational research on podiatric conditions and diseases to advance foot and ankle health and treatment options. The CRC will focus on research initiatives related to podiatric conditions, treatments, and interventions. This includes research in foot and ankle health, diabetic foot care, sports injuries, and congenital podiatric abnormalities. The role will involve working with a multidisciplinary team committed to advancing podiatric care through research, education, and quality improvement initiatives. The Clinical Research Coordinator will be a key member of the Research Team working closely with the Principal Investigator in coordinating clinical, behavioral, and community-engaged research to improve podiatric health outcomes. Under the direction of the Principal Investigator(s), Co-Investigators, and Research Manager, the Clinical Research Coordinator will perform various research duties for multiple research and quality improvement projects. Core responsibilities: Support IRB submissions and regulatory filings Adhere to IRB-approved protocols. Coordinate protocol-related research procedures, study visits, and follow-up care. Participate in the informed consent process of study subjects. Screen, recruit, and enroll patients/research participants. Support the safety of clinical research patients/research participants. Maintain study source documents. Under the supervision of PI, report adverse events. Understand Good Clinical Practice (GCP) and regulatory compliance. Educate subjects and families on protocol, study interventions, etc. Comply with institutional policies, standard operating procedures (SOPs), guidelines, HIPAA, and management of confidential materials. Comply with federal, state, and sponsor policies. Related responsibilities: Complete case report forms (paper & electronic data capture) and address queries. Submit documents to regulatory authorities (e.g., IRB, FDA) and/or review/monitoring boards (e.g., DSMB, independent safety officer). Facilitate pre-study, site qualification, study initiation, and monitoring visits as appropriate. Facilitate study close-out activities as appropriate. Collect, process, and ship samples as applicable to the protocol. Schedule subject visits and procedures. Retain records/archive documents after study closeout. Education Qualifications: Bachelors Degree preferred. Phlebotomy and/or Lab skills (MST, MSLT, etc) Experience Qualifications: At least three (3) years of clinical research-related experience required. Prior work in a medical clinic
    $40k-50k yearly est. 13d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Wilmington, DE?

The average clinical research associate in Wilmington, DE earns between $51,000 and $122,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Wilmington, DE

$79,000
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