Clinical Research Associate Jobs in Norristown, PA

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

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, visit ******************** and follow us on LinkedIn and X (Twitter). Uniquely Differentiated. Rapid. Elegant At Cabaletta, we are driven by the shared mission of developing cures, where a patients' own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. We're proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work About the Position The Associate Director / Director, Clinical Scientist will collaborate with cross-functional teams (Clinical, Regulatory, Medical Writing, Translational Sciences, CMC, etc.) on writing clinical study synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and TLF shells; participate in emerging clinical trial data evaluation and interpretation; ensure that assigned studies are conducted according to GCPs and Cabaletta's SOPs; conduct literature searches and reviews, meta-analyses, and publishing data; oversee the review of clinical study entries (clinical trial information and results) for posting to ********************** (clinical trial registry and results database) and assist in preparation of IND/ BLA filing and accelerated/pediatric programs packages. The span of responsibilities is broad and will support several clinical programs depending on their size and complexity. The Clinical Scientist will liaise with various vendors, and study investigators at participating sites. Responsibilities: Support the Medical Director or may serve as Clinical Lead in clinical science aspects of the assigned Cell Therapy program. Assists the Medical Director for clinical input to the clinical development plan (CDP) at all stages of the program. Leads (or supports) development of recommendations on further development strategies to internal committees. Member of the cross-functional clinical trial team for assigned studies. Participate in review of clinical and scientific data and developing product knowledge to understand and communicate the relevant information. Participate in development, maintenance, and review of clinical study documents (e.g., protocols and protocol amendment(s), informed consent documents, case report forms) and other relevant strategic documents. Support activities related to the start-up and execution of new clinical trials. Contribute relevant clinical sections to documents such as the IB, DSUR, CSRs, and for regulatory documents such as INDs/CTAs/ accelerated program/RMAT designations/pediatric study plans, and BLA/MAAs. Responsible for clinical data review and drafting reports and presentations on the various findings of the clinical research, including abstracts, posters, publications. Provide support with the activities related to the execution, monitoring, and reporting of clinical trials. Provides scientific/medical mentorship (or coordinates) to the study team, including the CRO team. Perform regular review of clinical data to ensure that the study is conducted in accordance with the protocol, safety procedures are followed, and efficiency is maintained. Assist with safety review procedures: tracking of safety events, review of new SAEs, and composing/editing adverse event narratives. Assist with managing vendor activities as needed. In collaboration with the Medical Director, identify clinical sites that will participate in trials. Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies. May attend Site Initiation Visits, to present the study design and key aspects of the protocol. Leads the compilation and interpretation of the data for and from safety review committees, collaborating closely with the Medical Director. Qualifications: Bachelor of Science degree from an accredited educational institution. Master's degree or PhD, PharmD/RN or the equivalent degree preferred. Minimum 7 years of experience in clinical drug development within a pharmaceutical/biotech or academic environment Strong knowledge of ICH, GCP, and other relevant regulatory guidelines Solid understanding of T-cell biology and cell & gene therapy Prior experience in cell therapy in pharma/biotech is a plus Experience in writing clinical protocols and performing and summarizing relevant literature reviews Strong communication and interpersonal skills Engaged, hands-on, and goal-oriented mentality in a highly dynamic work environment Ability to flexibly contribute simultaneously to multiple facets of drug development Demonstrated ability to learn new therapeutic areas and technologies Self-motivated, innovative, and critical thinker with strong commitment to follow up on action items Strong organizational, analytical, and problem-solving skills Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs Strong team orientation and passion for continuous self-development Experience in the biotech industry or in a startup industrial setting is preferred. Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression. For more information, please visit https://********************/join-our-crew Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans. Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation. And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm. #LI-REMOTE

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960

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.

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.

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Bilingual Clinical Research Coordinators at our Keystone Clinical Studies site in Plymouth Meeting, PA! The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends) Compensation: Hourly Rate based on experience + comprehensive benefits, PTO, and 401k match *paid overtime for weekend work, evening work, or early morning work as needed RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. QUALIFICATIONS Bachelor's degree preferred, but not required Experience working neurology studies is a plus, but not required - this site primarily conducts Alzheimer's clinical studies Phlebotomy experience is required, EKG or other patient labs/processes preferred Preferably 2+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

Responsible for the overall operation of one or more research studies, coordinates research through project recruitment, scheduling and retention of study subjects and exercising appropriate communication skills in order to ensure retention of subjects in the study. This is a fully grant-funded position. Essential Functions Assist in identifying and recruiting eligible participants for research study. Ensure coordination of subjects and study personnel as required by protocol. Act as liaison between study personnel and study participants. Encourage and motivate participants to maintain compliance and attendance throughout the duration of the study and coordinate all aspects of retention. Maintain study records and related documentation as required by protocol and regulatory bodies (internal and external). Work with external study sites and coordinating centers as required. Participate in study meetings (in-person and by phone) as required. Perform study related testing and/or procedures as certified/trained. Maintain the highest level of confidentiality regarding patient and study records. Assist in the training of study support staff and student interns as assigned. Support and complete all study related paperwork including requirements of the Internal Review Board. Conduct screenings of preschool children as necessary to maintain recruitment goals (after training). Other related duties as assigned. Required Qualifications Minimum of Bachelor's Degree in or the equivalent combination of education and work experience. Please review the Equivalency Chart for additional information. Minimum of Experience working in a research environment desirable Proficiency in computer based operations including word processing, spreadsheets, REDCap and data base software. Excellent time management and organizational skills Excellent record keeping skills Ability to work independently Excellent interpersonal skills Comfortable working with children Familiarity with standard concepts, practices and procedures within study related field and study specific skills. Physical Demands Typically sitting at a desk/table Location The Eye Institute - Oak Lane Additional Information This position is classified as Exempt, grade J Compensation for this grade ranges from [$ 47,490 to $71,230 per year] [. Please note that the offered rate for this position typically aligns with the minimum to midrange of this grade, but it can vary based on the successful candidate's qualifications and experience, department budget, and an internal equity review. Applicants are encouraged to explore the Professional Staff salary structure and Compensation Guidelines & Policies for more details on Drexel's compensation framework. For information about benefits, please review Drexel's Benefits Brochure. Special Instructions to the Applicant Please make sure you upload your CV/resume and cover letter when submitting your application. Additional Required Documents A review of applicants will begin once a suitable candidate pool is identified.

Could you be our next Clinical Research Assistant at Lankenau Institute for Medical Research? Why work as a Clinical Research Assistant with Main Line Health? * Make an Impact! As a Clinical Research Assistant, you will be supporting clinical research personnel in the implementation and management of clinical research activities. You will be assisting in screening and enrolling potential study patients as specified per protocol as assigned. Collaborate with your team in collecting and entering date required for research study. * Develop and Grow your Career! Invest in furthering your education through seeking certifications or advanced degrees by taking advantage of our Tuition Reimbursement! This position is eligible for up to $6,000 per year based upon your Full or Part Time status. * Join the Team! Like our patients, the Main Line Health Family encompasses a wide range of backgrounds and abilities. Just as each of our patients requires a personalized care plan, each of our employees, physicians, and volunteers, bring distinctive talents to Main Line Health. Regardless of our unique design, we all share a purpose: providing superior service and care. * Position-Specific Benefits include: We also offer a number of employee discounts to various activities, services, and vendors... And employee parking is always free! Position: Clinical Research Assistant Shift: Day Shift Experience: 1. Experience with Microsoft Office required. 2. Good verbal and written communication skills. Education: BS preferred or equivalent experience in clinical research preferred. Licensures/Certifications: N/A Additional Information * Requisition ID: 74757 * Employee Status: Regular * Schedule: Full-time * Shift: Day Job * Pay Range: $18.01 - $27.91 * Job Grade: 205

Part Time Clinical Research Coordinator-Opthalmology25000971Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The part-time Clinical Research Coordinator will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators to provide research support requiring the application of standard clinical research practices. The Clinical Research Coordinator will be responsible for the planning, implementation, and execution of Clinical Trials in the Ophthalmology department at the Temple University Lewis Katz School of Medicine. Currently, the department's research focuses on AI assisted diabetic retinopathy screening, Thyroid eye disease and intraocular lens for cataract surgery. Essential Functions: Responsibilities include assisting with screening, tracking and enrolling patients in active clinical trials; obtaining informed consent; scheduling and conducting study visits; preparing IRB submissions; acting as the primary contact for study sponsors and participants, processing and shipping laboratory specimens, interacting with study sponsors, faculty and staff, and collecting and entering study data into study database. The incumbent will schedule and participate in sponsor meetings and resolve queries in a timely fashion. Assist with start-up activities for new studies including feasibility review and pre-start up sponsor meetings. At Temple, you will find it easy to fit in while staying true to yourself. We value what makes each employee unique and strive to maintain a culture of diversity and inclusion. As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity. Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills and Abilities: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred Skills and Abilities: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant funded position. This position is assigned a hybrid work arrangement (on-campus and remote), the duration of this hybrid work arrangement is at the discretion of Temple University and the Department. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science HallWork Locations: Kresge Science Hall Schedule: Part-time Job Posting: Apr 16, 2025, 7:51:09 PM

We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will be responsible for recruiting, screening, and enrolling subjects into clinical trials, explaining the informed consent process, and documenting adverse events. You will also be responsible for collecting study documents, protocols, regulatory documents, informed consents, case report forms, and source documents, as well as preparing Institutional Review Board (IRB) applications. Responsibilities * Recruit, screen, and enroll subjects into clinical trials * Explain the informed consent process to patients * Document adverse events * Collect study documents, protocols, regulatory documents, informed consents, case report forms, and source documents * Prepare Institutional Review Board (IRB) applications Essential Skills * Experience in patient recruitment and consenting * Experience with adverse event reporting * Effective communication and writing skills * Knowledge of IRB and human research protection regulations * 1-3 years of clinical research experience Additional Skills & Qualifications * BA/BS preferred * Experience with in-hospital clinical research Work Environment This role involves a combination of office and hospital/outpatient surgery settings. The work environment is very fast-paced with a high volume of industry and investigator studies. You will be working in one of the most prestigious academic research institutes in the world, utilizing state-of-the-art equipment, and working on high-profile studies with well-known sponsors. Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information. Pay and Benefits The pay range for this position is $25.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 30, 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.

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

Clinical Research Coordinator Nephrology/Opthalmology - (25000844) Description Grade: T25 The link below will give you information about the University's “T”salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Clinical Research Coordinator will work under the direct supervision of the Director, CRORA in collaboration with the Principal Investigators to provide research support requiring the application of standard clinical research practices. The Clinical Research Coordinator will be responsible for the planning, implementation, and execution of Clinical Trials for both the Department of Medicine/section of Nephrology and Ophthalmology departments at the Temple University Lewis Katz School of Medicine. Performs other duties as assigned. Essential Functions: Responsibilities include assisting with screening, tracking and enrolling patients in active clinical trials; obtaining informed consent; scheduling and conducting study visits; preparing IRB submissions; acting as the primary contact for study sponsors and participants, processing and shipping laboratory specimens, interacting with study sponsors, faculty and staff, and collecting and entering study data into study database. The incumbent will schedule and participate in sponsor meetings and resolve queries in a timely fashion. Assist with start-up activities for new studies including feasibility review and pre-start up sponsor meetings. Additional responsibilities include working independently to drive day to day research activities, supporting multiple active protocols simultaneously, assisting with investigator-initiated research, writing protocols, submitting studies to local and central IRBs, maintaining regulatory compliance and documentation, updating study records on clinicaltrials.gov, and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations and Temple policies. Performs other duties as assigned. At Temple, you will find it easy to fit in while staying true to yourself. We value what makes each employee unique and strive to maintain a culture of diversity and inclusion. As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity. Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills and Abilities: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred Skills and Abilities: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). Hybrid work opportunities may be available. Duration and arrangements at the discretion of Temple University and the Department. This position requires a background check. This position requires Child Abuse Certifications prior to the commencement of service. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science HallJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Clinical Research Coordinator-Obstetrics - (25000641) Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Lewis Katz School of Medicine has an exciting opportunity for a clinical research Coordinator (CRC) to work on a translational grant funded by the National Institutes of Health that seeks to identify biomarkers and examine factors that are likely to influence the consequences of fetal alcohol exposure during pregnancy. The CRC will work under the Director, CRORA and will work closely with the research team of clinical and basic scientists to carry out all clinical aspects of this project. The CRC will recruit study participants, obtain informed consent, administer questionnaires, collect urine and blood samples, and assist with specimen processing and perform data management. The CRC will be involved with all day-to-day study activities and will be an integral member of the study team. Essential Functions: • Submissions to IRB for review and approval; • Maintenance of regulatory and study-related documents; • Patient recruitment and tracking participants throughout the study; • Obtaining informed consent; • Administration of the alcohol exposure questionnaire; • Storage of all clinical samples; • Oversee collection of blood samples from 300 subjects during their first visit with the OB/GYN team (first trimester), then during their follow-up visits during their second and third trimesters; • Processing, aliquoting and storing blood samples and urine in a freezer; • Perform all the biochemical and molecular assays, maintain inventories, order supplies, and generally will participate in the organization of the laboratory; • Data management and data entry; • Responsible for preparation of exosomal RNA and protein samples from serum, from EtOH-used subjects and controls; • Organizing matching groups for Controls and alcohol consumed cases for further biomarkers assays. Benefits of working at Temple University include: 403(B) Retirement Plan Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or Health Professions field and at least three years of directly related experience. An equivalent combination of education and experience may be considered. Required Skills: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC) Job: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will be responsible for recruiting, screening, and enrolling subjects into clinical trials. You will also play a key role in explaining the informed consent process, documenting adverse events, and collecting various study documents and protocols. Additionally, you will prepare Institutional Review Board (IRB) applications. Responsibilities * Recruit, screen, and enroll subjects into clinical trials * Explain the informed consent process to study participants * Document adverse events in a timely and accurate manner * Collect study documents, protocols, regulatory documents, informed consents, case report forms, and source documents * Prepare and submit Institutional Review Board (IRB) applications Essential Skills * Experience with patient recruitment and consenting * Strong understanding of the informed consent process * Proficiency in documenting adverse events * Knowledge of IRB and human research protection regulations * 2+ years of clinical research experience * Effective communication and writing skills Additional Skills & Qualifications * Bachelor's degree (BA/BS) preferred * Experience with in-hospital clinical research * Familiarity with oncology clinical trials * Knowledge of Good Clinical Practice (GCP) and Electronic Data Capture (EDC) Work Environment This position involves working in a combination of office and hospital/outpatient surgery settings. The work environment is very fast-paced with a high volume of industry and investigator studies. You will be part of one of the most prestigious academic research institutes in the world, working with state-of-the-art equipment on high-profile studies sponsored by well-known organizations. Pay and Benefits The pay range for this position is $28.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 30, 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.

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

Clinical Research Coordinator-Obstetrics - (25000641) Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Lewis Katz School of Medicine has an exciting opportunity for a clinical research Coordinator (CRC) to work on a translational grant funded by the National Institutes of Health that seeks to identify biomarkers and examine factors that are likely to influence the consequences of fetal alcohol exposure during pregnancy. The CRC will work under the Director, CRORA and will work closely with the research team of clinical and basic scientists to carry out all clinical aspects of this project. The CRC will recruit study participants, obtain informed consent, administer questionnaires, collect urine and blood samples, and assist with specimen processing and perform data management. The CRC will be involved with all day-to-day study activities and will be an integral member of the study team. Essential Functions: • Submissions to IRB for review and approval; • Maintenance of regulatory and study-related documents; • Patient recruitment and tracking participants throughout the study; • Obtaining informed consent; • Administration of the alcohol exposure questionnaire; • Storage of all clinical samples; • Oversee collection of blood samples from 300 subjects during their first visit with the OB/GYN team (first trimester), then during their follow-up visits during their second and third trimesters; • Processing, aliquoting and storing blood samples and urine in a freezer; • Perform all the biochemical and molecular assays, maintain inventories, order supplies, and generally will participate in the organization of the laboratory; • Data management and data entry; • Responsible for preparation of exosomal RNA and protein samples from serum, from EtOH-used subjects and controls; • Organizing matching groups for Controls and alcohol consumed cases for further biomarkers assays. Benefits of working at Temple University include: 403(B) Retirement Plan Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or Health Professions field and at least three years of directly related experience. An equivalent combination of education and experience may be considered. Required Skills: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC) Job: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Clinical Research Coordinator (Recruitment Only) - (16001534) Description The Clinical Research Coordinator, in collaboration with the Clinical Investigators at the Lewis Katz School of Medicine, 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; process informed consent paperwork; and ensure study payment is processed and received in a timely fashion. Additional responsibilities include working independently to drive day-to-day research activities; 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 at least three 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 strong attention to detail and 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:*Prior Surgical Department experience. *Experience with eDC database. Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status protected by law.Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and. employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety and can be found at: ********************************** You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Student Faculty CenterJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will be responsible for recruiting, screening, and enrolling subjects into clinical trials, explaining the informed consent process, and documenting adverse events. You will also be responsible for collecting study documents, protocols, regulatory documents, informed consents, case report forms, and source documents, as well as preparing Institutional Review Board (IRB) applications. Responsibilities * Recruit, screen, and enroll subjects into clinical trials * Explain the informed consent process to patients * Document adverse events * Collect study documents, protocols, regulatory documents, informed consents, case report forms, and source documents * Prepare Institutional Review Board (IRB) applications Essential Skills * Experience in patient recruitment and consenting * Experience with adverse event reporting * Effective communication and writing skills * Knowledge of IRB and human research protection regulations * 1-3 years of clinical research experience Additional Skills & Qualifications * BA/BS preferred * Experience with in-hospital clinical research Work Environment This role involves a combination of office and hospital/outpatient surgery settings. The work environment is very fast-paced with a high volume of industry and investigator studies. You will be working in one of the most prestigious academic research institutes in the world, utilizing state-of-the-art equipment, and working on high-profile studies with well-known sponsors. Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information. Pay and Benefits The pay range for this position is $25.00 - $31.25/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 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.

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