Clinical Research Coordinator Jobs in Pike Creek Valley, DE

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

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.

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.

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.

APPLICATION INSTRUCTIONS: * CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday. * CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday. * If you are NOT a current employee or student, please click "Apply" and complete the application process for external applicants. JOB DESCRIPTION AND POSITION REQUIREMENTS: The Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Coordinator. The Beat Childhood Cancer Research Consortium (BCC) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This position supports clinical trial research across these 50+ hospital sites and has a specialized focus on research project operations including study methodologies, protocol development, logistical support, project management and timelines. For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org) Job Duties & Responsibilities: * Complete assigned projects, develop work plans, and oversee project phases to ensure effective and efficient workflow. * Maintain compliance with Good Clinical Practice (GCP) guidelines and applicable regulations throughout the trial life cycle. * Develop and assist in administering regulatory compliance for the Beat Childhood Cancer Research Consortium. * Provide training and support to study site personnel on protocol requirements, study procedures, and regulatory compliance. * Serve as a resource for study teams and investigators regarding study-related inquiries and issues. Maintains communication and contact lists across 50+ sites. * Help to develop and maintain Study Specific Case Report Forms and study documents as well as verbiage in clinical trial protocols and supporting documents. * Develop relationships with BCC and University staff, research collaborators, other BCC institutions, and regulators as necessary and in the best interests of the program. Teammate will evaluate and resolve issues or problems as they arise. * Develop and implement new guidelines and procedures that will streamline the office operations. * Flexibility to adapt to changing circumstances. * Excellent organizational skills, multitasking and communication both written and spoken. The ideal candidate will have a strong background in REDCap data entry and experience working with central Institutional Review Boards (IRB). It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork. Minimum Education & Experience: * Bachelor's Degree * 3+ years of relevant experience * Or an equivalent combination of education and experience This is a limited-term position funded for one year from date of hire, with possibility of refunding. The following clearances must be successfully completed for this position: * Pennsylvania State Police Criminal Background Check * Pennsylvania Child Abuse History * Federal Bureau of Investigation (FBI) Criminal Background Check The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms. We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission. The salary range for this position, including all possible grades is: $56,200.00 - $81,500.00 Salary Structure - additional information on Penn State's job and salary structure. CAMPUS SECURITY CRIME STATISTICS: Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here. Employment with the University will require successful completion of background check(s) in accordance with University policies. EEO IS THE LAW Penn State is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact ************. Federal Contractors Labor Law Poster PA State Labor Law Poster Affirmative Action Penn State Policies Copyright Information Hotlines Hershey, PA

Study Setup and Specimen Coordinator Job Title: Study Setup and Specimen Coordinator Location: Exton, PA/on-site Reports To: Project Manager, Team Lead Full-time Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. POSITION OVERVIEW: Key responsibilities of the position: When a new specimen is received, the Study Setup and Specimen Coordinator needs to Process e-Manifest Update Specimen Trackers Provide update to the clients regarding specimen status Work with Specimen Processing (BioA and Central Lab) closely on Sample Management including specimen status, problem reconciliation, as well as generation of related SOPs Work with BioA closely on analysis status for studies Assist laboratory management and QA specialist with CAPA, Change Control, and other processes Trouble Shooting Other responsibilities as needed Requirements: Has a High School Diploma or higher Experience working with laboratory specimens Has excellent communication skills ESSENTIAL SKILLS include the following: The skills listed below are representative of those that are required to perform this job successfully. Interview questions should be designed to verify/validate that the candidate possesses the specified below. High level of accountability with self and others Hands-on approach with a desire to teach others Track record of challenging the status quo Team and action-oriented Problem-solving Priority setting Salary and Benefits : Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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.

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

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

Study Setup and Specimen CoordinatorJob Title: Study Setup and Specimen Coordinator Reports To: Project Manager, Team Lead Full-time Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. POSITION OVERVIEW: Key responsibilities of the position: When a new specimen is received, the Study Setup and Specimen Coordinator needs to Process e-Manifest Update Specimen Trackers Provide update to the clients regarding specimen status Work with Specimen Processing (BioA and Central Lab) closely on Sample Management including specimen status, problem reconciliation, as well as generation of related SOPs Work with BioA closely on analysis status for studies Assist laboratory management and QA specialist with CAPA, Change Control, and other processes Trouble Shooting Other responsibilities as needed Requirements: Has a High School Diploma or higher Experience working with laboratory specimens Has excellent communication skills ESSENTIAL SKILLS include the following: The skills listed below are representative of those that are required to perform this job successfully. Interview questions should be designed to verify/validate that the candidate possesses the specified below. High level of accountability with self and others Hands-on approach with a desire to teach others Track record of challenging the status quo Team and action-oriented Problem-solving Priority setting Salary and Benefits: Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance. Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.