Clinical Research Coordinator Jobs in Washington, NJ

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

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

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

Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Biology who would like to lend your expertise to train AI models? About the opportunity: Outlier is looking for talented Biology or related fields expert to help train generative artificial intelligence models This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you You may contribute your expertise by…Assessing the factuality and relevance of domain-specific text produced by AI models Crafting and answering questions related to BiologyEvaluating and ranking domain-specific responses generated by AI models Examples of desirable expertise:A bachelor's or higher degree in Biology or a related subject Experience working as an Biology professional Ability to write clearly about concepts related to Biology in fluent EnglishPayment:Currently, pay rates for core project work by Biology experts range from $30 to $50 per hour USD. Rates vary based on expertise, skills assessment, location, project need, and other factors. For example, higher rates may be offered to PhDs. For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply. Certain projects offer incentive payments. Please review the payment terms for each project.

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

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

The Senior Research Associate, in collaboration with the Principal Investigators, will be responsible for the planning, implementation, and execution of clinical trials in the assigned department. Primary responsibilities include the coordination of study enrollment; oversight of study protocols; and submission of research activities per IRB regulations. The incumbent will establish and maintain databases of subjects; monitor data collection for accuracy; process informed consent paperwork; and ensure that study payment is processed and received in a timely fashion. Additional responsibilities include working independently to drive day-to-day research activities; monitoring and tracking expenditures; supporting multiple active protocols simultaneously; and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations. Performs other duties as assigned. Required Education and Experience: Bachelor's degree in life science, health professions or related field and four years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills and Abilities: *Demonstrated computer and data entry skills, and proficiency with MS Office Suite software programs. *Demonstrated knowledge of IRB protocols and processes. *Strong written and verbal communication skills. *Strong interpersonal skills, along with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to work independently or as part of a team. *Demonstrated analytical and problem solving skills, with strong attention to detail. *Demonstrated organizational and time management skills, along with the ability to adhere to project deadlines. *Ability to travel to off-site locations that may not be accessible via public transportation. *Ability to work evenings/weekends hours as needed. Preferred: *Experience with eDC database.

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

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

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

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

Clinical Research Coordinator- Pool24003069Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A 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. Summary: The Clinical Research Coordinator, under the direction of the Director, CRORA and Clinical Investigators, will be responsible for the planning, implementation, and execution of Clinical Research studies in one or more departments in the Lewis Katz School of Medicine at Temple University. Incumbent will work independently to drive day to day research activities from study start-up to closeout. Founded in 1901 as Pennsylvania's first co-educational medical school, the Lewis Katz School of Medicine has attained a national reputation for training humanistic clinicians and biomedical scientists. The school attracts students and faculty committed to making a difference in patient care, research, education and public service - at home and across the globe. The Lewis Katz School of Medicine at Temple University has experienced dramatic growth in the breadth and scope of its research enterprise over the past decade. As part of its strategic plan, our researchers and scientists have been responsible for ground-breaking advancements in areas across the scientific spectrum, including: Cancer Biology, Cardiovascular and Thrombosis, Cell and Developmental Biology, Clinical Lung Research, HIV, Immunology and Autoimmunity, Metabolic Syndrome and Diabetes, Neuroscience, Substance Abuse, Translational Medicine and more. Essential Functions: · Coordinate recruitment and enrollment of research participants; · establish and maintain databases of subjects; · schedule and conduct study visits; · collect and enter data; register subjects and study visits in OnCore; · perform Epic research billing review; · maintain an up to date regulatory binder; · schedule and attend sponsor visits; and prepare and submit IRB paperwork to ensure compliance with IRB regulations. · Incumbent may assist with grant or manuscript preparation and · maintenance of investigator-initiated studies registered on clinicaltrials.gov; · support multiple active protocols simultaneously; · work with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations. Benefits of working at Temple University include: Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & 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. Required Skills & Abilities: **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. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines. *Knowledge of FDA, IRB, Pennsylvania and related regulations. Preferred **Prior experience with IRB submissions both local and central. *Prior experience processing and shipping biological samples a plus *Prior phlebotomy certification or willing to learn a plus *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. There may be an opportunity for a hybrid work schedule depending on the department and study-specific needs. This position requires a background check. This position requires Child Abuse Certifications prior to the commencement of service. This is a grant funded position. 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. In accordance with the City of Philadelphia's COVID-19 mandate, all Temple University students, faculty, staff, and contractors working in a healthcare setting must be fully vaccinated before receiving authorization to work unless they have a medical or religious exemption approved by the University. An individual is considered fully vaccinated two (2) weeks following the second dose of the Pfizer or Moderna vaccine or two (2) weeks following a single dose of the Johnson & Johnson vaccine. Individuals who do not meet the University's vaccination or exemption requirement will be prohibited from working until proof of full vaccination or an exemption is requested and approved. For more information, visit the University's Vaccines web page at ******************************************** 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. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science HallWork Locations: Kresge Science Hall Schedule: Full-time Job Posting: Oct 3, 2024, 8:39:40 PM

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

Nemours is seeking a Clinical Research Coordinator to join our Nemours Children's Health team in Wilmington, DE. The Clinical Research Coordinator for the NCH-Delaware Orthogenetics Department coordinates, implements and completes clinical research studies and/or clinical trials involving rhizomelic chondrodysplasia punctata (RCDP) 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. Requirements: Bachelor's degree in medical or science related field required 1-3 years Clinical Research Coordination experience required Effectively uses Microsoft computer software Demonstrates ability to coordinate and establish priorities among diverse tasks Effectively communicates verbally and in writing 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.

Nemours is seeking a Clinical Research Coordinator to join our Nemours Children's Health team in Wilmington, DE. The Clinical Research Coordinator for the NCH-Delaware Orthogenetics Department coordinates, implements and completes clinical research studies and/or clinical trials involving rhizomelic chondrodysplasia punctata (RCDP) 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. Requirements: * Bachelor's degree in medical or science related field required * 1-3 years Clinical Research Coordination experience required * Effectively uses Microsoft computer software * Demonstrates ability to coordinate and establish priorities among diverse tasks * Effectively communicates verbally and in writing 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.

Clinical Research Coordinator (Genito-Urinary Unit) - (246498) Description Coordinates and facilitates the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provides leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety and data quality. The position will work closely with the members of the clinical research team to develop effective tools for close monitoring and reporting of trials accrual, and coordinate the timely study activation and submission of protocol amendments. This position supports the Fox Chase Cancer Center Office of Clinical Research at Temple University Hospital, Main Campus or East Norriton and Buckingham Campuses. In addition, this position is expected to interact with the institutional investigators, other members of the healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials. Flexibility in work schedule, when possible, must be maintained to ensure coverage of study responsibilities. EducationBachelors Degree (Required) Graduate Level Classes or Degree in a relevant program (Preferred) Combination of relevant education and experience may be considered in lieu of degree. Experience2 Years direct experience in a healthcare setting preferably oncology or clinical trials or a minimum of 3 Years related experience (Required) General experience and knowledge of chemotherapy and/or radiation therapy administration (Preferred) Previous experience performing phlebotomy and specimen processing (Preferred) License/CertificationsCCRC - Cert Clin Research Coordinator (Preferred) or CCRP - Cert Clin Research Prof (Preferred) or ACRP-CP - Assn Clin Res Prof - Cert Prof (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

Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Biology who would like to lend your expertise to train AI models? About the opportunity: Outlier is looking for talented Biology or related fields expert to help train generative artificial intelligence models This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you You may contribute your expertise by…Assessing the factuality and relevance of domain-specific text produced by AI models Crafting and answering questions related to BiologyEvaluating and ranking domain-specific responses generated by AI models Examples of desirable expertise:A bachelor's or higher degree in Biology or a related subject Experience working as an Biology professional Ability to write clearly about concepts related to Biology in fluent EnglishPayment:Currently, pay rates for core project work by Biology experts range from $30 to $50 per hour USD. Rates vary based on expertise, skills assessment, location, project need, and other factors. For example, higher rates may be offered to PhDs. For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply. Certain projects offer incentive payments. Please review the payment terms for each project.

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

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