Clinical Research Coordinator Jobs in Pennsauken, 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

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 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.

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 primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product. Responsibilities * Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol. * Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research. * Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects * Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies * Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits * Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance * Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem * The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. * Skills:* CRA, Monitoring, Medical Device, CRO, ICH, GCP, FDA, Clinical Research, Clinical Trials * Top Skills Details:* CRA,Monitoring,Medical Device * Additional Skills & Qualifications:* Bachelor of Science Degree 4-5 Years + experience with a Sponsor or CRO Site Monitoring Experience Work experience at more than 1 company Experience with set-up monitoring plan, conducted site monitoring, and conducted site close-out. Medical Device preferred, Pharma OK, CRO OK * Experience Level:* - Entry Level

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.

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.

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple trials within Oncology + Quality of life focus wtih Regional Travel + Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes - Mentors/coaches junior flex team + Acts as Lead SM-training other SMs on study + Develops site start up documents for studies including SIV agenda + Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines) + Represents LTMs or SMs on SMTs/meetings + Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial + Supports country budget development and/or contract negotiation in liaison with CCS colleagues + Assists with ASV + Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces - Primary/Other: + Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. + Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) **You Are:** + B.S., R.N., or equivalent degree, preferably in Biological Sciences + Located in Chicago near a major airport + Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials + Have a minimum of 1-3 years' experience monitoring Oncology trials + Knowledge of several therapeutic areas + Analytical/risk-based monitoring experience is an asset + Ability to actively drive patient recruitment strategies at assigned sites + Ability to partner closely with investigator and site staff to meet all of our study timelines + Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). + Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. + Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. + Need to travel up to 50% + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs + Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead + Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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.

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.

Job Title Clinical Research Coordinator II Reporting to Regional Research Manager Permanent Full Time (1099) Contractor Position Provides study information and obtains relevant information as required by the protocol, from patients who are participating in, or interested in clinical studies. Assists in the recruitment and screening of volunteers, schedules patient visits in EMR, provides information to potential subjects and those participating in clinical trials and obtains relevant medical history by telephone and in person. Collects relevant medical records when needed. The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, advertising when funds are available, referrals from rheumatologists and other staff and may include attending health fairs and community outreach. Reviews and administers the informed consent form to subjects; allowing them time to read and ask questions. Provides progress notes in EMR and source documents to describe procedures at each visit. Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following: Obtaining patient medical history and medication lists Phlebotomy and basic laboratory tests Patient education and training ECG Administer Questionnaires Vital signs Assist with Joint counts and other assessments Data Entry Study drug administration, including injections Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events. Follow-up with the subject and collateral informants as needed. Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program. Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate Institutional Review Board (IRB) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process. Serves as a liaison to all physicians and AARA employees. Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards. Provides all AARR research subjects with an excellent service experience by consistently demonstrating professional decorum Assignment and Review of Work All new AARA employees will agree initial objectives to be assessed on completion of their 90-day initial review period. Thereafter, all employees will enter the annual appraisal cycle under the AARA Talent, Performance and Career Management Policy where annual appraisals will be conducted by their Line Manager and CRO. Further information on the appraisal cycle calendar is available from the HR Manager and from the Talent, Performance and Career Management Policy on the AARA Intranet. Communication and Relationships The postholder must have strong interpersonal and relational talents. Success in this role involves building and maintaining relationships with internal and external stakeholders Demands of the Job Role requires frequent light physical effort. The role requires a combination of sitting, standing and walking. Role requires frequent, moderate mental effort. The role requires a consistent high level of concentration, attention to detail and organization. Role requires frequent, light emotional exposure to distressing diagnoses. Occasional direct moderate emotional exposure to patients or relatives who may be ill, upset, distressed or angry. Role requires frequent exposure to hazardous materials and contact with contained bodily fluids. Requirements 11. Knowledge, Skill, Training and Experience to do the Job Essential Bachelors Degree in science related field Good Clinical Practice Certification (GCP) Clinical Research Coordinator Certification, (CRCC) preferred Experience in Phlebotomy & Clinical Assessments (Vitals, ECG, etc) Experience in biospecimen handling and processing

The Clinical Research Coordinator will coordinate the direct running of investigator-initiated research studies, including recruiting, enrolling, and retaining research participants. This role involves participating in the informed consent process, scheduling, conducting screenings, verifying source information in Electronic Health Records, completing case report forms, and working with systems such as Oncore, REDCAP, and IRIS. The CRC will facilitate all aspects of human subjects' participation for study visits. Responsibilities * Interact directly with study participants in person, by phone, and/or email. * Receive study participants and facilitate remote engagement. * Work with investigators and research leadership to ensure timely data documentation and sharing. * Communicate regularly with the Research Director/Principal Investigator and Assistant Director of Research. * Coordinate and schedule visits with other professionals involved in the studies. * Ensure protocol procedures are followed with regard to study participants. * Generate requests for physician orders as needed for study procedures. * Assist in recruiting, enrolling, retaining, and tracking human subjects for various research projects. * Conduct prescreening and assist in conducting face-to-face and virtual informed consent. * Facilitate and schedule Zoom meetings with the Principal Investigator. * Document informed consent and ensure correct randomization or study group assignment. * Manage subject documentation in study databases, administer surveys and assessments, and track participants in Oncore and EPIC. * Discuss and provide updates on project progress with investigators and the Assistant Director regularly. * Assist with regulatory, operational, clinical, and technical aspects of research as needed. * Monitor, report, and escalate participant concerns or problems, adverse events, incidental findings, protocol deviations, and/or unanticipated adverse effects in a timely manner. Essential Skills * Clinical research * Chart review * Pre-screening patients * Clinical trial * Patient recruitment * Medical record handling * EDC systems * EPIC systems * Data entry * Scheduling research subject appointments * Direct patient care * Comfortable with complex patient populations Additional Skills & Qualifications * SOCRA certification * ACRP certification * CITI Training * GCP knowledge * Cardiology experience * Bachelor's Degree preferred * 2+ years of human subject research experience Work Environment This is a fully on-site opportunity, primarily reporting to the Villanova site, with occasional training in Center City. The work hours range from 20-30 hours a week, with the potential to increase to 40 hours. The role involves working in the infusion and imaging areas. Benefits include medical, dental, and vision coverage, paid holidays, sick leave for the city of Philadelphia, and free parking at the Villanova site. The position offers the chance to work in various therapeutic areas, including integrative medicine and mindfulness-based stress reduction, and provides opportunities for publication and collaboration with renowned physicians. Pay and Benefits The pay range for this position is $28.00 - $32.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Philadelphia,PA. Application Deadline This position is anticipated to close on Mar 28, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Your Tomorrow is Here! Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals. Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc., and Temple Transport Team. Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University. To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike. At Temple Health, your tomorrow is here! Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 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. 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. Education Bachelors 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. Experience 2 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/Certifications CCRC - Cert Clin Research Coordinator (Preferred) or CCRP - Cert Clin Research Prof (Preferred) or ACRP-CP - Assn Clin Res Prof - Cert Prof (Preferred) _

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

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.

) Contract Duration: Open ended contract (expected duration is 3 months) Job Type: Full-time 40 hours per week (Monday-Friday) - during normal business hours We are seeking a full-time, onsite Clinical Research Coordinator (CRC) with experience in clinical research to support an ongoing Pulmonology clinical trial. The ideal candidate will be able to work independently and act as one of the main CRCs for this study. As the position and study progress, additional responsibilities may be assigned. The candidate must be flexible and willing to assist with various tasks as needed. Key Responsibilities: * Patient Recruitment: Identify and recruit suitable patients for the clinical trial. * Medical Record Review: Conduct thorough reviews of patient medical records. * Participant Screening: Perform phone screenings or prescreen participants for eligibility. * Informed Consent: Obtain informed consent from trial participants. * Data Management: Collect study data and enter it into electronic data capture (EDC) systems. * Query Resolution: Address and resolve data queries promptly. * Medical Record Retrieval: Obtain necessary medical records for the study. * Documentation: Create and maintain source documents. * Participant Follow-Up: Conduct follow-up with study subjects to ensure retention. * Scheduling: Arrange in-patient visits and follow-up appointments, and send reminders. * General Support: Assist with any other study-related efforts as deemed necessary by the site. Qualifications: * Minimum of two years of experience as a Clinical Research Coordinator * Proficiency with electronic medical records (EMR) and electronic data capture (EDC) systems * This position is onsite and does not offer relocation* Recruiter: Shelby Ciardelli Pay and Benefits The pay range for this position is $25.00 - $32.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Philadelphia,PA. Application Deadline This position is anticipated to close on Mar 24, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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