Clinical research coordinator jobs in Vineland, NJ - 118 jobs

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

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

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, 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

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $35-$41/h depending on education, experience, and skillset. Essential Responsibilities and Duties: Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Oversees study protocol scheduling and collection of data. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities. Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness. Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator II position. Bachelor's degree, preferred. CCRC certification preferred. 5 years of experience in the medical field or Masters Degree, preferred. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Clinical Research 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.

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

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.

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.

Clinical Research Coordinator II The Clinical Research Coordinator II, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings Any other matters as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a preferred Foreign Medical Graduates preferred Experience: At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is a plus

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

Clinical Research Coordinator-Obstetrics - (25003512) Description The Temple University's Lewis Katz School of Medicine's OBGYN Department is searching for a Clinical Research Coordinator-Obstetrics 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: T26Learn more about the “T” salary structure Salary Range: Up to $58,000. 00 per yearA 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. Job Details:*This position will be on-site*This position requires the following background checks: Cash Handling*This position is at the Health Science campus and at the Fetal Center of the Temple Women and Family Hospital. Position Summary: The Lewis Katz School of Medicine has an exciting opportunity for a clinical research Coordinator (CRC) to work on a translational grant funded by the National Institutes of Health that seeks to identify biomarkers and examine factors that are likely to influence the consequences of fetal alcohol exposure during pregnancy. The CRC will work under the LKSOM Clinical Research Nurse Manager and will work closely with the research team of clinical and basic scientists to carry out all clinical aspects of this project. The CRC will recruit study participants, obtain informed consent, administer questionnaires, collect urine and blood samples, and assist with specimen processing and perform data management. The CRC will be involved with all day-to-day study activities and will be an integral member of the study team. The position requires in-person attendance at the performance site and cannot be done on a hybrid/remote basis. Required Education and Experience: Bachelor's degree in life science or Health Professions field and at least three years of directly related experience. An equivalent combination of education and experience may be considered. Responsibilities:*Submissions to IRB for review and approval. *Maintenance of regulatory and study-related documents. *Patient recruitment and tracking participants throughout the study. *Obtaining informed consent. *Administration of the alcohol exposure questionnaire. *Storage of all clinical samples. *Oversee collection of blood samples from 300 subjects during their first visit with the OB/GYN team (first trimester), then during their follow-up visits during their second and third trimesters. *Processing, aliquoting and storing blood samples and urine in a freezer. *Data management and data entry. *Organizing matching groups for controls and alcohol consumed cases for further biomarkers assays. *Performs other duties as assigned Required Skills and Abilities: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred Experience:*Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system*Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). 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) Job: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Clinical Research Coordinator-Pool - (25003464) Description 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 HallJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

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.

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

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation of $28-33/h, and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Compensation: $28-33/h depending on experience, education and skillset Essential Responsibilities and Duties: Assists with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelors Degree, preferred. 0-3 years of experience in the medical field. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Clinic Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Any other matters, as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is preferred

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

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