Clinical research coordinator jobs in Lower Merion, PA

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.

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

CLINICAL TRIAL SYSTEM COORDINATOR - FOX CHASE CANCER CENTER - (253287) Description Support the ongoing maintenance activities for the CTO Clinical Research Management System (CRMS). Facilitate regulatory review process by providing customer support and assist in training of Clinical Research Systems users. Perform Quality Control and Quality assurance activities to verify and maintain accurate and complete protocol metadata in Clinical Research Systems. Provide metric reporting and study tracking as required by Senior Leadership. EducationBachelors Degree : Computer Science, Information Technology, or Science related field (Required) Masters Degree : Computer Science, Information Technology, or Science related field (Preferred) Combination of relevant education and experience may be considered in lieu of degree. Experience1 Year experience working with Clinical Research Software or equivalent experience with software of comparable complexity (Required)2 Years experience working in Clinical Research Operations and Coordination. Experience in a comparable academic or industry environment will be considered (Preferred) General experience and knowledge of database applications and theory, clinical research software systems, medical research methods and operations, medical terminology and computer report generation software (Preferred)_ Your Tomorrow is Here!Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc. , and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here!Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Your Tomorrow is Here! As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years. Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion. At Fox Chase, we consider defeating cancer to be our calling. Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in. It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known. Apply today to be part of the future of prevailing over cancer. Primary Location: Pennsylvania-PhiladelphiaJob: Research & ScienceSchedule: Full-time Shift: Day JobEmployee Status: Regular

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Travel Clinical Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access Research to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact * Study Preparation: * Ability to understand and follow institutional SOPs * Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. * Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct * Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff * Assist with planning and creation of appropriate recruitment and marketing materials * Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. * Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies * Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives * Assist in the creation or review of protocol specific source documents * Determine facility, equipment and outsource vendor requirements and availability * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance * Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks * Study Management: * Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. * Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies * Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records * Collect and evaluate concomitant medications * Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. * Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings * Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials * Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion * Maintain effective relationships with study participants and other Care Access Research personnel * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management * Strong and clear communication skills, both verbally and in writing * Accept accountability for actions and function independently * Patient Coordination: * Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment * Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial * Administer delegated study questionnaires, where appropriate. * Collect and evaluate medical records with the support of medically qualified members of the study team. * Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion * Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) * Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol * Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround * Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. * Monitor patient progress on study medication * Documentation: * Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP * Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. * Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart * Accurately transcribe data to CRF or EDC. * Resolve data management queries and correct source data as needed * Record protocol exemptions and deviations as appropriate with sponsor. * Complete Note(s)-to-File for patient chart and regulatory filing if necessary * Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing * Maintain copies of patient-specific correspondence in source charts * Assist regulatory personnel with completion of continuing/final review reports * Perform other duties as assigned. The Expertise Required * Excellent working knowledge of clinical trials, medicine and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ * Ability to communicate and work effectively with a diverse team of professionals * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel. * Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision Certifications/Licenses, Education, and Experience: * BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred * RN or LPN preferred * Research Professional Certification- CRCC or exam eligibility preferred * A minimum of 3 to 4 years Clinical Research experience * A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together * Location: This position is for a full-time temporary, hourly role. * Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study. * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Clinical Research Coordinator - (25003181) Description Temple University's Lewis Katz School of Medicine Department of Nephrology/Ophthalmology is searching for a Clinical Research Coordinator!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: T25 Learn more about the “T” salary structure. Salary Range: $50,000 to $60,000A 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 Summary: The Clinical Research Coordinator will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators to provide research support requiring the application of standard clinical research practices. The Clinical Research Coordinator will be responsible for the planning, implementation, and execution of Clinical Trials for both the Department of Medicine/section of Nephrology and Ophthalmology departments at the Temple University Lewis Katz School of Medicine. Required Education and Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Responsibilities: •Assist with screening, tracking and enrolling patients in active clinical trials•Obtaining informed consent•Scheduling and conducting study visits•Preparing IRB Submissions•Acting as the primary contact for study sponsors and participants•Processing and shipping laboratory specimens•Interacting with study sponsors, faculty and staff. •Collecting and entering study data into study databases. •schedule and participate in sponsor meetings, and resolve queries in a timely fashion•Assist with start-up activities for new studies including feasibility review and pre-start-up sponsor meeting Additional responsibilities include: •working independently to drive day to day research activities•supporting multiple active protocols simultaneously•supporting multiple active protocols simultaneously, assisting with investigator-initiated research•writing protocols, submitting studies to local and central IRBs, maintaining regulatory compliance and documentation, updating study records on clinicaltrials. gov•working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations and Temple policies•Performs other duties as assigned Additional Information:•This is an onsite position on the Health Science Campus. There may be opportunities for a hybrid work arrangement depending on the department and the study-specific needs. •This position requires a background check•This position requires Child Abuse Certifications prior to the commencement of service Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other status protected by law. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Go here to review: *************** temple. edu/reports-logs/annual-security-report. 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

The Clinical Research Coordinator coordinates, implements and completes clinical research studies and/or clinical trials in the Neonatology Department at the Nemours Philadelphia Thomas Jefferson University location by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases. Essential Functions Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS. Participates in continuous process improvement initiatives and implementation of outcomes Prepares for internal and external audits. Prepares corrective action plans as indicated. Requirements Bachelor's degree in medical or science related field required 1-3 years research experience Effectively uses Microsoft computer software Demonstrates ability to coordinate and establish priorities among diverse tasks Effectively communicates verbally and in writing About Us Nemours Children's Health is an internationally recognized children's health system. With more than 1.7 million patient encounters annually, we provide medical care in five states through two freestanding state-of-the-art children's hospitals - Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida. Our pediatric network includes 80 primary-urgent-and specialty care practices and more than 40 hospitalists serving 19 affiliated hospitals. We generate annual revenues of more than $1.7 billion derived from patient services, contributions from the Alfred I. DuPont Trust, as well as other income. As one of the nation's premier pediatric health systems, we're on a journey to discover better ways of approaching children's health. Putting as much focus on prevention as cures and working hand in hand with the community to make every child's world a place to thrive. It's a journey that extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention, leading to the healthiest generations of children ever. Inclusion and belonging guide our growth and strategy. We are looking for individuals who are passionate about, and committed to, leading efforts to provide culturally relevant care, reducing health disparities, and helping build an inclusive and supportive environment. All of our associates are expected to ensure that these philosophies are embedded in their day-to-day work with colleagues, patients and families. To learn more about Nemours Children's and how we go well beyond medicine, visit us at *************** .

Job Details The Clinical Research Coordinator for Neurosurgery works on observational and interventional research, spanning industry sponsored and investigator initiated clinical trials of novel treatments in multiple Neurology divisions. This is a patient facing position with responsibility for subject identification, consenting, data collection and entry, lab sample processing, and maintenance of study documentation according to federal regulations and good clinical practice guidelines. Job Description 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. 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. EDUCATION AND REQUIREMENTS REQUIREMENTS: High School Diploma or equivalent and 6 years of clinical research experience or Bachelors degree and 2 years of clinical research experience or Masters 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 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

Unblinded Clinical Research Coordinator DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP. Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans. Provide consultative support regarding the preparation and dosing of drugs. Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction. Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials. Understand and apply all applicable site procedures. Ensure receipt and proper storage of IP and bioretention samples. Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy. Review protocols and provide input on clinical and pharmacy supply needs. Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information. Temperature reporting. Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs. Knowledge & Experience: Education: High School Diploma or equivalent required Foreign Medical Graduate is a plus Pharmacy Technician Certification a plus Experience: Clinical Experience Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant) Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Docs. Excellent communication and customer service skills. Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred but not required

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

Job Details Philadelphia - Philadelphia, PAClinical Research Coordinator III A CRC III (with Spirometry Experience) will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To 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 and overseeing 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 and overseeing 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, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols. 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). Ability to train and mentor site staff, as needed Supervise 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). Maintaining a working knowledge of Study Participants' Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team. Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) 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. 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 Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Any other matters as assigned by management KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree preferred Foreign Medical Graduates preferred Experience: Minimum of 5 years experience in Clinical Research Supervisory experience preferred Wide therapeutic range of clinical trials experience preferred Regulatory research experience is a plus Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Goals-driven while continuously maintaining quality. Must be detailed-oriented, proactive, and able to take initiative. Must have strong written and communication skills. Must have excellent customer service skills. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred.

The Clinical Research Coordinator coordinates, implements and completes clinical research studies and/or clinical trials in the Neonatology Department at the Nemours Philadelphia Thomas Jefferson University location by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases. Essential Functions Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS. Participates in continuous process improvement initiatives and implementation of outcomes Prepares for internal and external audits. Prepares corrective action plans as indicated. Requirements Bachelor's degree in medical or science related field required 1-3 years research experience Effectively uses Microsoft computer software Demonstrates ability to coordinate and establish priorities among diverse tasks Effectively communicates verbally and in writing

Idea Evolver is seeking a forward-thinking AI-Search Coordinator to join our growing team. This is not your typical SEO role-we're looking for someone who understands people and integrates AI into their everyday workflow. As part of our team, you'll explore how audiences discover information across both traditional and emerging AI-driven platforms, translating those insights into strategies that drive content performance and client growth. You'll collaborate closely with leaders in healthcare and other regulated industries to help them adapt to the future of AI-driven digital discovery.What You'll Do Conduct advanced search behavior research using our AI-powered platform, SEMrush, Google Search Console, and other leading tools. Leverage AI to streamline research, surface patterns, and deliver actionable insights faster. Transform search and performance data into clear, compelling stories and recommendations for clients. Support technical SEO best practices to ensure websites meet modern performance, accessibility, and indexability standards. Monitor and interpret performance metrics (via Google Analytics and other platforms), delivering optimization strategies that move the needle. Stay at the forefront of AI-driven search and conversational experiences, helping clients position their content for visibility in these new discovery environments. Deliver client-ready materials-reports, roadmaps, presentations-that drive meaningful business outcomes. What We're Looking For A human who loves what they do and is energized by solving complex problems. A human who wants to contribute to building AI solutions for search and content discovery. 4+ years of experience in SEO, search analytics, or related digital marketing roles. Outstanding communication skills-able to turn complex insights into engaging, client-friendly narratives. Proven ability to collaborate across disciplines in fast-moving, data-driven environments. Experience in healthcare, life sciences, or other regulated industries is a plus. Why Join Idea Evolver Collaborate with a forward-thinking agency at the forefront of AI and search innovation. Partner with high-profile clients in healthcare and consumer industries. Be part of a collaborative, growth-oriented culture where your ideas directly influence outcomes. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional development. Ready to help shape the future of AI-powered search? Apply today to join Idea Evolver's AI-Search & Analytics team and lead the charge into the next era of digital discovery.

Support the ongoing maintenance activities for the CTO Clinical Research Management System (CRMS). Facilitate regulatory review process by providing customer support and assist in training of Clinical Research Systems users. Perform Quality Control and Quality assurance activities to verify and maintain accurate and complete protocol metadata in Clinical Research Systems. Provide metric reporting and study tracking as required by Senior Leadership. Education Bachelors Degree : Computer Science, Information Technology, or Science related field (Required) Masters Degree : Computer Science, Information Technology, or Science related field (Preferred) Combination of relevant education and experience may be considered in lieu of degree. Experience 1 Year experience working with Clinical Research Software or equivalent experience with software of comparable complexity (Required) 2 Years experience working in Clinical Research Operations and Coordination. Experience in a comparable academic or industry environment will be considered (Preferred) General experience and knowledge of database applications and theory, clinical research software systems, medical research methods and operations, medical terminology and computer report generation software (Preferred) _ '350995

Clinical Research Coordinator25003181Description Temple University's Lewis Katz School of Medicine Department of Nephrology/Ophthalmology is searching for a Clinical Research Coordinator!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: T25 Learn more about the “T” salary structure. Salary Range: $50,000 to $60,000A 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 Summary: The Clinical Research Coordinator will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators to provide research support requiring the application of standard clinical research practices. The Clinical Research Coordinator will be responsible for the planning, implementation, and execution of Clinical Trials for both the Department of Medicine/section of Nephrology and Ophthalmology departments at the Temple University Lewis Katz School of Medicine. Required Education and Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Responsibilities: •Assist with screening, tracking and enrolling patients in active clinical trials•Obtaining informed consent•Scheduling and conducting study visits•Preparing IRB Submissions•Acting as the primary contact for study sponsors and participants•Processing and shipping laboratory specimens•Interacting with study sponsors, faculty and staff. •Collecting and entering study data into study databases. •schedule and participate in sponsor meetings, and resolve queries in a timely fashion•Assist with start-up activities for new studies including feasibility review and pre-start-up sponsor meeting Additional responsibilities include: •working independently to drive day to day research activities•supporting multiple active protocols simultaneously•supporting multiple active protocols simultaneously, assisting with investigator-initiated research•writing protocols, submitting studies to local and central IRBs, maintaining regulatory compliance and documentation, updating study records on clinicaltrials. gov•working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations and Temple policies•Performs other duties as assigned Additional Information:•This is an onsite position on the Health Science Campus. There may be opportunities for a hybrid work arrangement depending on the department and the study-specific needs. •This position requires a background check•This position requires Child Abuse Certifications prior to the commencement of service Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other status protected by law. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Go here to review: *************** temple. edu/reports-logs/annual-security-report. 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) Schedule: Full-time Job Posting: Dec 10, 2025, 2:39:01 PM

About the Role The Clinical Research Coordinator (CRC) is responsible for conducting and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations. What You'll Be Doing Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1-3 clinical research protocol) and evaluates/analyzes clinical data and trial results. Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract. Acts as a liaison between sponsor and the research department. In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria. Acts as a study resource for patients and family. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation. Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction. Dispenses study medications in accordance to protocol requirements within his/her scope of practice. Performs Investigational Product accountability for accurate compliance. Collects, processes and ships blood/urine specimens at scheduled times. Supervisors scheduling of research patient visits and procedures consistent with protocol requirements. Performs study specific procedures, including but not limited to ECG's, vital signs, height, weight, injections etc. within his/her scope of practice. Collect, compile and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups. Responsible for the reporting of and follow up on adverse events and serious adverse events per study protocol. Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance. Contacts outside health care providers and communicates with subjects to obtain follow up information. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Ensures filing and maintenance of all regulatory documents. Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums. Maintains required continuing education hours required for certifications. Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS). Maintains a high level of patient confidentiality. Performs all other duties as assigned. What We Expect from You Associates or Bachelor's Degree from an accredited college or university. Good Clinical Practice (GCP) Certificate International Air Transport Association (IATA) Certificate CCRC certification through an accredited organization (ACRP/SoCRA) is required 2-3 years related Research experience Preferred. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. 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. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Travel Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected. Salary Range $17- $22 per hour The compensation range listed reflects the anticipated base pay for this position. Actual compensation will be determined based on factors such as relevant experience, education, skills, and work location. What We are Offer You At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters” Compassion Make Someone's Day Collaboration Achieve Possibilities Together Respect Treat people with dignity Accountability Do the right thing Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more. About US Urology Partners U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy. U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.

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

The Clinical Research Coordinator coordinates, implements and completes clinical research studies and/or clinical trials in the Neonatology Department at the Nemours Philadelphia Thomas Jefferson University location by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases. Essential Functions Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS. Participates in continuous process improvement initiatives and implementation of outcomes Prepares for internal and external audits. Prepares corrective action plans as indicated. Requirements Bachelor's degree in medical or science related field required 1-3 years research experience Effectively uses Microsoft computer software Demonstrates ability to coordinate and establish priorities among diverse tasks Effectively communicates verbally and in writing

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

Your Tomorrow is Here! Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here! Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Support the ongoing maintenance activities for the CTO Clinical Research Management System (CRMS). Facilitate regulatory review process by providing customer support and assist in training of Clinical Research Systems users. Perform Quality Control and Quality assurance activities to verify and maintain accurate and complete protocol metadata in Clinical Research Systems. Provide metric reporting and study tracking as required by Senior Leadership. Education Bachelors Degree \: Computer Science, Information Technology, or Science related field (Required) Masters Degree \: Computer Science, Information Technology, or Science related field (Preferred) Combination of relevant education and experience may be considered in lieu of degree. Experience 1 Year experience working with Clinical Research Software or equivalent experience with software of comparable complexity (Required) 2 Years experience working in Clinical Research Operations and Coordination. Experience in a comparable academic or industry environment will be considered (Preferred) General experience and knowledge of database applications and theory, clinical research software systems, medical research methods and operations, medical terminology and computer report generation software (Preferred) _ Your Tomorrow is Here! As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years. Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion. At Fox Chase, we consider defeating cancer to be our calling. Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in. It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known. Apply today to be part of the future of prevailing over cancer.