Clinical research associate jobs in Hampden, PA - 219 jobs

Coordinates with Principal Investigator to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines. Participant pre-screening, recruitment and scheduling Complete protocol and trial system training Maintenance of regulatory documents Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study. Conducting participant visits Ability to perform basic lab and clinical procedures per protocol, such as: blood specimen collection (phlebotomy), blood pressure, vitals, EKGs, centrifuge operation, storing and shipping of lab specimens, and accountability of specimens and notification of courier for specimen pick-up Entering data in the EDC and resolving all queries Updating and maintaining trial logs and participant charts

**Penn State Health** - **Hershey Medical Center** **Work Type:** Full Time **FTE:** 1.00 **Shift:** Day **Hours:** Day **Recruiter Contact:** Denisse M. Rosado at ******************************** (MAILTO://********************************) **SUMMARY OF POSITION:** Responsible for assisting with the implementation of clinical research protocols under Physician Investigator and/or Clinical Research Specialists and coordinators. Participate in a variety of activities involved in the analysis, collection, compilation, and documentation of clinical research data. **MINIMUM QUALIFICATION(S):** + Either Associates Degree in a science or healthcare related field which includes job related coursework required or three (3) years experience in a healthcare or research setting required, or Bachelor's degree in a science or healthcare related field. + Active certification and/or appropriate licensure in respective field of expertise required (e.g. LPN, MLT, EMT, MA), if applicable. **WHY PENN STATE HEALTH?** Penn State Health offers exceptional opportunities to learn and grow, exposure to a wide patient population, and the ability to provide individualized, innovative, and specialized care to patients in the community. **Penn State Health offers an exceptional benefits package including medical, dental and vision with no waiting period as well as a Total Rewards Program that highlights a few of the many additional offerings below:** + **_Be Well_** with Employee Wellness Programs, and Fitness Discounts (University Fitness Center, Peloton). + **_Be Balanced_** with Generous Paid Time Off, Personal Time, and Paid Parental Leave. + **_Be Secured_** with Retirement, Extended Illness Bank, Life Insurance, and Identity Theft Protection. + **_Be Rewarded_** with Competitive Pay, Tuition Reimbursement, and PAWS UP employee recognition program. + **_Be Supported_** by the HR Solution Center, Learning and Organizational Development and Virtual Benefits Orientation, Employee Exclusive Concierge Service for scheduling. **WHY PENN STATE HEALTH MILTON HERSHEY MEDICAL CENTER?** Penn State Hershey Medical Center is Central Pennsylvania's only Academic Medical Center, Level 1 Regional Adult and Pediatric Trauma Center, and Tertiary Care Provider. As a four-time Magnet-designated hospital, Hershey Medical Center values the hard work and dedication that our employees exhibit every day. Through our core values of Respect, Integrity, Teamwork, and Excellence, our employees are a team committed to compassionate care for our diverse patient population, our community and each other. As a valued team member, we promote continued professional development, specialty certification, continuing education, and career growth. **YOU TAKE CARE OF THEM. WE'LL TAKE CARE OF YOU. State-of-the-art equipment, endless learning, and a culture of excellence - that's Penn State Health. But what makes our healthcare award-winning? That's all you.** _This job posting is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. Eligibility for shift differential pay based on the terms outlined in company policy or union contract._ _All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities._ _Penn State Health is an Equal Opportunity Employer and does not discriminate on the basis of any protected class including disability or veteran status. Penn State Health's policies and objectives are in direct compliance with all federal and state constitutional provisions, laws, regulations, guidelines, and executive orders that prohibit or outlaw discrimination._ **Union:** Non Bargained **Position** Associate Clinical Research I - Clin HV Cardio Research **Location** US:PA: Hershey | Research | Full Time **Req ID** 85729

CRA II OR Senior CRA (home-based in the U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field. + Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. + In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license \#LI-MM2 \#LI-Remote **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 maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here (****************************************************** 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. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

Apply now Penn State Health - Hershey Medical Center Work Type: Full Time FTE: 1.00 Shift: Day Hours: Day Recruiter Contact: Denisse M. Rosado at [email protected] Responsible for assisting with the implementation of clinical research protocols under Physician Investigator and/or Clinical Research Specialists and coordinators. Participate in a variety of activities involved in the analysis, collection, compilation, and documentation of clinical research data. MINIMUM QUALIFICATION(S): * Either Associates Degree in a science or healthcare related field which includes job related coursework required or three (3) years experience in a healthcare or research setting required, or Bachelor's degree in a science or healthcare related field. * Active certification and/or appropriate licensure in respective field of expertise required (e.g. LPN, MLT, EMT, MA), if applicable. WHY PENN STATE HEALTH? Penn State Health offers exceptional opportunities to learn and grow, exposure to a wide patient population, and the ability to provide individualized, innovative, and specialized care to patients in the community. Penn State Health offers an exceptional benefits package including medical, dental and vision with no waiting period as well as a Total Rewards Program that highlights a few of the many additional offerings below: * Be Well with Employee Wellness Programs, and Fitness Discounts (University Fitness Center, Peloton). * Be Balanced with Generous Paid Time Off, Personal Time, and Paid Parental Leave. * Be Secured with Retirement, Extended Illness Bank, Life Insurance, and Identity Theft Protection. * Be Rewarded with Competitive Pay, Tuition Reimbursement, and PAWS UP employee recognition program. * Be Supported by the HR Solution Center, Learning and Organizational Development and Virtual Benefits Orientation, Employee Exclusive Concierge Service for scheduling. WHY PENN STATE HEALTH MILTON HERSHEY MEDICAL CENTER? Penn State Hershey Medical Center is Central Pennsylvania's only Academic Medical Center, Level 1 Regional Adult and Pediatric Trauma Center, and Tertiary Care Provider. As a four-time Magnet-designated hospital, Hershey Medical Center values the hard work and dedication that our employees exhibit every day. Through our core values of Respect, Integrity, Teamwork, and Excellence, our employees are a team committed to compassionate care for our diverse patient population, our community and each other. As a valued team member, we promote continued professional development, specialty certification, continuing education, and career growth. YOU TAKE CARE OF THEM. WE'LL TAKE CARE OF YOU. State-of-the-art equipment, endless learning, and a culture of excellence - that's Penn State Health. But what makes our healthcare award-winning? That's all you. This job posting is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. Eligibility for shift differential pay based on the terms outlined in company policy or union contract. All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities. Penn State Health is an Equal Opportunity Employer and does not discriminate on the basis of any protected class including disability or veteran status. Penn State Health's policies and objectives are in direct compliance with all federal and state constitutional provisions, laws, regulations, guidelines, and executive orders that prohibit or outlaw discrimination. Union: Non Bargained Apply now Join our Penn State Health Talent Network Get job alerts tailored to your interests and updates on new roles delivered to your inbox. Sign Up Now

CRA II OR Senior CRA (home-based in the U.S.) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical Research Associate or Clinical Research Associate II to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 1 year independent monitoring to be considered for a Clinical Research Associate II and a minimum of 3 years independent monitoring to be considered for a Senior Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license #LI-MM2 #LI-Remote 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 maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here 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. Are you a current ICON Employee? Please click here to apply

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

APPLICATION INSTRUCTIONS: * CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. Please do not apply here, apply internally through Workday. * CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. Please do not apply here, apply internally through Workday. * If you are NOT a current employee or student, please click "Apply" and complete the application process for external applicants. JOB DESCRIPTION AND POSITION REQUIREMENTS: he Beat Childhood Cancer Research Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Monitor. The Beat Childhood Cancer Research Consortium (BCC) is an international clinical research sponsor and acts as a Contract Research Organization (CRO) of a network of 50+ hospitals across the US and Canada that participate in BCC's investigator-initiated clinical trials. This job does require travel to BCC hospital sites for monitoring visits approximately every 4-6 weeks. The ideal candidate will have a strong background in Clinical Trial Management, Human Subjects Research, and IND/IDE regulatory requirements. It is important that the candidate have experience working with a team, multiple Principal Investigators, and Phase I/II clinical trial projects. The candidate must have strong verbal and written communication skills and be able to multi-task while fostering an environment of collaboration and teamwork. For more information on BCC visit our website: Home | Beat Childhood Cancer (beatcc.org) BCC Specific Position Roles: The Clinical Trial Research Monitor is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. This position is the primary contact between the Investigational Sites and BCC Leadership. Key responsibility of this position is ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements and BCC SOPs. * Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. * Foster internal and external relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines. * In collaboration with Regulatory teammates, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials. * Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the BCC Study Monitoring Plan for each BCC study. This includes all monitoring visit types across all phases of a clinical trial including Site Initiation, Site Monitoring and Site Close Out. Visits may be conducted either onsite or remote as needed. * Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to BCC promptly. * Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Study Monitoring Plan. * Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Study Monitoring Plan and the Protocol. * Provide guidance to sites to help establish and/or enhance processes for data collection and data management. Educate BCC enrolling sites staff concerning protocols, EDC and regulatory requirements and expectations. This position will be filled at an Professional, Intermediate Professional depending on the candidate's education and experience. This position requires a Bachelor's Degree and 1+ years of relevant experience or an equivalent combination of education and experience. Additional education and/or experience required for higher level positions. This is a limited-term position funded for one year from date of hire, with possibility of refunding. This job requires that you operate a motor vehicle as a part of your job duties. A valid US driver's license and successful completion of a motor vehicle records check will be required in addition to standard background checks. Employment will require successful completion of background check(s) in accordance with University polices. The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms. We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission. The salary range for this position, including all possible grades is: $56,200.00 - $89,600.00 Salary Structure - additional information on Penn State's job and salary structure. CAMPUS SECURITY CRIME STATISTICS: Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here. Employment with the University will require successful completion of background check(s) in accordance with University policies. EEO IS THE LAW Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact ************. Federal Contractors Labor Law Poster PA State Labor Law Poster Penn State Policies Copyright Information Hotlines Hershey, PA

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Nuclear Medicine Technology Faculty and Clinical Coordinator Time Type: Full time and Qualifications: is for the LANCASTER, PA location. The Clinical Coordinator of the Nuclear Medicine Technology (NMT) Program provides effective leadership in developing, conducting, and ongoing assessment of the clinical education program. This includes but is not limited to review, revision, and implementation of curriculum, student recruitment and progression, simulation integration, and management of the program's clinical activities. The Clinical Coordinator works closely with the Nuclear Medicine Technology Program Director and the Executive Director of Allied Health Program in the School of Nursing and Allied Health (SNAH). This is a 12-month full time faculty position with both clinical and teaching responsibilities. Essential Duties and Responsibilities: ● Promotes and contributes to enhancing the University's high-performing learner-centered environment. ● Facilitates didactic, laboratory, and/or clinical instruction, using strategies that stimulate interest and maximize student learning. ● Incorporates current theories, research, and practice into the design of instruction, including plans for development and revision of curriculum. ● Supervises and assesses student learning to achieve outcomes at the course and/or program level. ● Contributes to the development, implementation, and evaluation of courses, programs, and School strategies. ● Demonstrates a commitment to scholarship through professional development that enhances teaching, learning, and administrative capabilities. ● Demonstrates service to the SNAH, the University, profession, and /or community. ● Participates in faculty and leadership meetings within the SNAH. ● Demonstrates a commitment to scholarship through participation in professional development that enhances teaching and learning. ● Assists in the daily operations of the program as instructed by the Program Director and/or the Director of Allied Health Programs. ● Models professional values in support of the mission, vision, educational outcomes, and strategic direction of the University. ● Performs other duties that may be in the best interest of the SNAH and University as requested by academic leadership. In addition to the job duties listed above, the Clinical Coordinator is responsible for the following: ● Responsible for the daily operations of clinical education, including program administration, organization, and supervision of students to optimize program effectiveness. ● Facilitates frequent and consistent contact with students, clinical faculty, and clinical affiliates in all program locations. ● Coordinates clinical assignments and experiences at the clinical affiliates. ● Monitors student compliance with site requirements. ● Contacts and evaluates clinical sites for suitability as a required or elective rotation experience and works with site representatives to identify suitable preceptors to supervise students. ● Ensures orientation to the program's requirements of the personnel who supervise or instruct students at clinical sites. ● Ensures appropriate supervision/assessment of students is available at all clinical sites. ● Organizes and develops clinical curriculum needed for the development of evolving practice skills. ● Assesses the overall effectiveness of the clinical training for all students. ● Works with the Program Director to ensure that student clinical experiences are coordinated with didactic and laboratory education. ● Manages student issues according to program-specific, SNAH, and University policies. ● Collaborates with the Program Director and Strategic Enrollment Management in student recruitment, retention, and marketing efforts. ● Participates in periodic program assessments, such as continuous quality review, evaluation of program effectiveness, and improvement of the program. ● Assists the Program Director in the training and onboarding of regular and adjunct faculty in the classroom, laboratory, and clinical settings. ● Contributes to the development, review, and revisions to program outcomes, curriculum, course syllabi, course evaluations, policies, and procedures. ● Provides effective leadership in developing, conducting, and ongoing assessment of the clinical education program. ● Conducts in-person site visits at each clinical site once per semester. Minimum Qualifications: Required ● Bachelor's degree from an accredited academic institution. ● Certification and registration in nuclear medicine technology from a national certification board. ● Have a minimum of two years post‐certification nuclear medicine technology experience. ● Excellent verbal and written communication. ● Ability to solve problems creatively and effectively. ● Exceptional interpersonal skills. ● High level of emotional intelligence and self-awareness. ● Ability to work independently and collaboratively as required by the circumstances. ● Flexibility in managing a dynamic and evolving academic program. Preferred ● ARRT (CT) certification; preferred but not required. Saint Joseph's University is a private, Catholic, Jesuit institution and we expect members of our community to be knowledgeable about - and to make a positive contribution to - our mission. Saint Joseph's University is an equal opportunity employer that seeks to recruit, develop and retain a talented and diverse workforce. The University is committed to the diversity of its faculty and staff so that our students, our disciplines and our community as a whole can benefit from the multiple perspectives it offers. The University seeks qualified candidates who share our commitment to equity, diversity and inclusion. EOE Saint Joseph's University prohibits discrimination on the basis of sex in its programs and activities, including admission and employment, in accordance with Title IX of the Education Amendments of 1972. The Title IX Coordinator is responsible for overseeing compliance with Title IX and other civil rights laws and regulations. To contact the Title IX Coordinator, e-mail ***************, visit Campion Student Center suite 243, or call ************. To learn more about the University's Title IX policies, the process for filing a report or formal complaint of sex discrimination, sexual harassment, or other form of sexual misconduct, and the University's response to reports and/or formal complaints, please visit ******************** Inquiries may also be directed to the Federal agency responsible for enforcing Title IX, the U.S. Department of Education Office for Civil Rights. Applicant Information & Disclosures Please review this article of important information pertaining (but not limited) to: Background checks, the Form I-9, Equal Opportunity Employment (EOE), and Title IX. Applicant Information & Disclosures Please review this article of important information pertaining (but not limited) to: Background checks, the Form I-9, Equal Opportunity Employment (EOE), and Title IX. Pay Transparency & Benefits Overview Please click to read more about the university's approach to pay and benefits transparency. Adjunct instructor compensation can be found in the article. Otherwise, an estimated pay range is listed below. This position's estimated pay range is: $70,000.00 - $80,000.00

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

We are seeking an experienced Clinical Research Coordinator to join a dynamic team at one of the most prestigious academic research institutes in the world. You will be working with state-of-the-art equipment on high-profile studies sponsored by well-known organizations. Your role will be crucial in pioneering scientific discoveries in cancer research and translating these discoveries into new models of cancer prevention and treatment. Responsibilities * Coordinate and manage clinical research projects, ensuring they meet established timelines and objectives. * Interact comfortably and professionally with physicians and other healthcare professionals. * Conduct patient enrollment, informed consent, and patient scheduling. * Perform chart reviews and data entry following Good Clinical Practice (GCP) guidelines. * Manage oncology research studies as a study coordinator. * Report adverse events using CTCAE 4.0 and manage cancer medication protocols. * Ensure compliance with IRB and human research protection regulations. Essential Skills * Minimum of two to three years of clinical research experience. * Strong experience in oncology research and clinical coordination. * Proficiency in MS Office Suite. * Knowledge of IRB and human research protection regulations. Additional Skills & Qualifications * Experience in lymphoma or oncology preferred. * Experience with cancer medications and adverse event reporting preferred. Work Environment The work environment is fast-paced and takes place on a large campus. You will be part of the largest lymphoma team at the cancer center, which includes 2 project managers, a nurse practitioner, 5 clinical research nurses, 5 clinical research coordinators, and 3 research assistants. The team aligns its staff with specific principal investigators they support, focusing heavily on CAR-T studies. The Cancer Center enjoys a vibrant, well-funded research base with a mission to reduce cancer incidence, mortality, and morbidity while training future cancer researchers. It ranks fifth in funding from the National Cancer Institute and fourth in American Cancer Society funding. Job Type & Location This is a Contract to Hire position based out of Philadelphia, PA. 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 Jan 21, 2026. 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. 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Full-time Description We are seeking an on-site Clinical Research Coordinator to join our growing CCAY Clinical Research team! This position is a full-time (Monday-Friday) ON-SITE position in York, PA. About Us For more than 40 years, Cancer Care Associates of York has been an independent, physician-owned practice dedicated to serving the York, PA community. Our mission is to provide compassionate, patient-centered oncology and hematology care while supporting our staff with a collaborative, growth-minded environment. Learn more about us: *********************** What you will be doing... Under the guidance and supervision of the Lead Clinical Research Nurse Coordinator, in collaboration with the Principal Investigator (PI), the Clinical Research Coordinator plays a key role in ensuring the integrity, quality, and compliance of clinical research studies. This position is responsible for supporting and coordinating clinical trials in accordance with Good Clinical Practice (GCP) guidelines as well as applicable federal, state, and local regulations. The Clinical Research Coordinator will actively participate in patient recruitment, informed consent, protocol compliance, data collection, and patient education while maintaining accurate and timely documentation. Essential Functions Qualified individuals must have the ability - with or without reasonable accommodation - to perform the following: Collaborate with PI and research team to develop study timelines, processes, and source documents in adherence to study protocols. Coordinate and participate in study initiation visits and site monitoring activities. Recruit, screen, and enroll patients into clinical trials in alignment with study requirements and enrollment goals. Present study concepts to patients, participate in informed consent discussions, and ensure accurate consent documentation. Collect, process, and verify research data, samples, and/or specimens following strict protocol requirements. Conduct blood draws, EKGs, and obtain patient vitals as needed per the scope of practice. Monitor patients for adverse events, protocol compliance, and response to investigational therapies, thoroughly documenting all findings. Accurately enter, maintain, and review case report forms and research data per FDA guidelines. Maintain investigational product accountability and provide patient education on drug administration procedures. Educate patients, their families, and clinic staff regarding research protocols and investigational agents. Remain audit-ready through consistent, accurate documentation and adherence to regulatory standards. Attend required meetings, ongoing education programs, and maintain certifications such as GCP and IATA. Requirements Desired Professional Skills and Experience: Previous clinical research experience is preferred. Certified Medical Assistant (CMA), Licensed Practical Nurse (LPN), or Register Nurse (RN) preferred; unlicensed professionals with clinical research experience may be considered. Knowledge of or training in Good Clinical Practice (GCP) guidelines preferred; the candidate will be required to complete GCP training and other training Excellent communication and organizational skills Independence, multitasking, and attention to detail Experience in Microsoft Word and Excel SoCRA or ACRP certification preferred, or willingness to obtain within 2-3 years of hire. What we offer: Competitive Compensation & Generous Paid Time Off 401(K) & Profit Sharing Plan w/ generous company contribution Affordable Medical, Dental, and Vision Plans Life Insurance Plan - company paid Employee Assistance Program Short & Long Term Disability Plans (voluntary) Consistent Day Schedule (M-F) w/ no weekends, evenings or holidays

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

Clinical Research Coordinator-Pool - (25003464) Description Temple University's Clinical Research Department is searching for a Clinical Research Coordinator to join our team!Become a part of the Temple family and you will have access to the following: Full medical, dental, vision coverage Paid time off 11 Paid Holidays Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE A generous retirement plan and so much more!Salary Grade: T25Learn more about the “T” salary structure Salary Range: $50,000 to $55,000A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details. Job Details:*This is a grant-funded position*This position requires the following background checks: Cash Handling *Clinical Research Coordinators may be hired for a specific department or as a pooled coordinator. *Hybrid work options may be considered depending on study and departmental needs. Position Summary: The Clinical Research Coordinator works under the leadership of the Principal Investigator and/or other Research Staff and is responsible for specific research tasks associated with clinical research projects or clinical trials, ensuring high-quality data collection, regulatory compliance, and seamless study operations. As a Clinical Research Coordinator, you will also have the opportunity to advance your career through our structured step increase program. We also recognize and reward professional development. Coordinators who successfully earn industry-recognized certifications, such as the Certified Clinical Research Professional (CCRP ) through SOCRA or the Certified Clinical Research Coordinator (CCRC ) through ACRP, may qualify for advancement sooner. At Temple University's Lewis Katz School of Medicine, you will be part of a nationally recognized, state-of-the-art research community that is driving innovation in patient care. Our clinical research programs span a wide range of disciplines and provide coordinators with the opportunity to contribute to groundbreaking studies that directly impact the health and well-being of diverse populations. With access to advanced resources, collaborative teams, and a strong commitment to excellence, Temple offers an ideal environment for Clinical Research Coordinators to grow their careers while shaping the future of medicine. Required Education and Experience: Bachelor's degree in a life science or other health professions field*A minimum of three years of related experience *An equivalent combination of education and experience may be considered. Responsibilities:The Clinical Research Coordinator performs study coordination tasks independently, following established protocols and procedures. The coordinator makes decisions that require interpretation of policies, procedures, or instructions to ensure accurate and compliant execution of clinical research projects. *Oversees the day-to-day activities of all assigned research projects and clinical trials. *Screens, tracks, and enrolls patients in clinical trials and other research studies for the Lewis Katz School of Medicine at Temple University. Schedule and attend sponsor visits. *Enrolls human subjects for clinical trials. Obtains informed consent, schedules subjects for visits, performs clinical assessments and collects and enters study data. *Performs various research, database, and clerical tasks to support clinical trials, aiding investigators in organizing, gathering, and compiling clinical research data. *Organizes and maintains documentation required for clinical trials and/or other research projects. Maintains up-to-date regulatory binders. *Inform the Principal Investigator or designated individual about any issues regarding patient responses to treatment, medication, or adverse effects. *May submit IRB paperwork to ensure compliance with IRB regulations. *Assist the Principal Investigator with Institutional Review Board (IRB) filings and annual reviews. *Offer clerical and technical support to ensure adherence to research protocols and maintain the quality of information received. *May prepare, review, and submit IRB and regulatory paperwork, ensuring full compliance with institutional, FDA, IRB, and state requirements; supports complex filings and amendments. Adheres with FDA, IRB, Pennsylvania, and other applicable regulations. *Performs other duties as assigned*May present project updates at clinical research meetings and/or assist with grant or manuscript preparation. Performs other duties as assigned Required Skills and Abilities:*Demonstrated computer skills, and proficiency with MS Office Suite software programs. *Aptitude in professionalism*Excellent written and oral communications skills*Ability to work evenings/weekends hours as needed. *Knowledge of medical terminology*Able to resolve problems/issues*Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants*Demonstrated organizational and prioritization skills, along with the ability to work in a dynamic environment and to perform multiple tasks simultaneously. *Knowledge of IRB and human subject protection*Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines. *Ability to travel to off-site locations that may not be accessible via public transportation. *Strong time management skills Preferred Skills and Abilities:*Prior experience with IRB submissions. *Prior experience processing and shipping biological samples. *Prior phlebotomy certification or willing to learn. *Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders. *Prior Electronic Data Capture (eDC) data entry skills. *Prior research experience in a healthcare setting. *Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies. 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. Go here to review. You may request a copy of the report by calling Temple University's Department of Public Safety at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science HallJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

CLASSIFICATION: Faculty 12-month, part-time DEPARTMENT: School of Rehabilitation Sciences, College of Health FLSA STATUS: Exempt SUPERVISION RECEIVED: Associate Dean of School of Rehabilitation Sciences; Program Director, Doctorate of Speech-Language Pathology SUPERVISION EXERCISED: N/A POSITION SUMMARY: Moravian University invites applications for a part-time, twelve-month clinical professor position (at the level of assistant or associate clinical professor) in the Speech-Language Pathology Doctorate (SLPD) program to serve as the Applied Research and Practice Coordinator. The primary responsibility of this role is to coordinate and support the successful completion of the applied research and practice projects that serve as the culminating project in the SLPD program. The faculty member will work collaboratively with students, mentors, and the program director to foster scholarly inquiry and translational application within the profession of speech-language pathology. This includes the day-to-day operations of the applied research and practice process. Moravian University's SLPD program is remote with one intensive on-campus learning experience. Thus, there is opportunity for this position to be remote. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Facilitate mentor-student matches Ensure academic writing standards Sponsor the IRB process Provide individualized support to students related to the applied research and practice process Maintain ongoing communication with students regarding their projects Contribute to policy and program development Support students to align projects with program expectations Teach coursework in the area of expertise or related to the applied research and practice course Participate in departmental, college, and university service initiatives Review of applications will begin on December 15, 2025. All positions are subject to budget availability. QUALIFICATIONS: Earned doctorate required (SLPD, PhD, EdD) Minimum of 5 years of experience practicing as a speech-language pathologist Active State SLP license ASHA CCC Preferred Evidence of an established scholarly agenda preferred At least 3 years of experience teaching academic courses or mentoring students or professionals (e.g., supporting advocacy projects, theses, capstones, dissertations, student research projects, community outreach, workplace improvement projects, supervision of student clinicians or clinical fellows, etc.) Demonstrated excellence in academic writing and familiar with APA-7 guidelines TO APPLY: Qualified candidates should attach their (1) cover letter, (2) curriculum vita, (3)statement of teaching philosophy, (4) statement of mentorship philosophy, and (5) names and contact information for at least three (3) references to their online application by clicking “Apply Now”. Please attach documents as a PDF file. Review of the applications will begin December 15, 2025, and continue until the position is filled. Incomplete applications will not be considered.

Works under direct supervision and assists research coordinators with organizing, gathering and compiling clinical research data. Tracks and maintains credentialing documentation for staff and all researchers participating in clinical trials in accordance with IRB regulations. May provide clerical and technical support to ensure adherence to research protocols and quality of information received. Performs a variety of research, data base and clerical duties in support of clinical trials to assist investigators in organizing, gathering and compiling clinical research data. Organizes and maintains documentation required for clinical trial(s). Informs Principal Investigator and/or designated individual on any issues concerning patient's response to treatment/medication/ any adverse effects overall to patients. Assists Principal Investigator with IRB filings and annual reviews. May assist in the enrollment of human subjects. Education: Minimum High School Diploma or equivalent. AND Experience: Experience in research or clinical setting preferred. Work Shift Workday Day (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson University Primary Location Address 833 Chestnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here

Benefits: 401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance The CRC will work at the Foot & Ankle Center in Bryn Mawr, Pennsylvania. The center is dedicated to conducting basic, clinical, and translational research on podiatric conditions and diseases to advance foot and ankle health and treatment options. The CRC will focus on research initiatives related to podiatric conditions, treatments, and interventions. This includes research in foot and ankle health, diabetic foot care, sports injuries, and congenital podiatric abnormalities. The role will involve working with a multidisciplinary team committed to advancing podiatric care through research, education, and quality improvement initiatives. The Clinical Research Coordinator will be a key member of the Research Team working closely with the Principal Investigator in coordinating clinical, behavioral, and community-engaged research to improve podiatric health outcomes. Under the direction of the Principal Investigator(s), Co-Investigators, and Research Manager, the Clinical Research Coordinator will perform various research duties for multiple research and quality improvement projects. Core responsibilities: · Support IRB submissions and regulatory filings · Adhere to IRB-approved protocols. · Coordinate protocol-related research procedures, study visits, and follow-up care. · Participate in the informed consent process of study subjects. · Screen, recruit, and enroll patients/research participants. · Support the safety of clinical research patients/research participants. · Maintain study source documents. · Under the supervision of PI, report adverse events. · Understand Good Clinical Practice (GCP) and regulatory compliance. · Educate subjects and families on protocol, study interventions, etc. · Comply with institutional policies, standard operating procedures (SOPs), guidelines, HIPAA, and management of confidential materials. · Comply with federal, state, and sponsor policies. Related responsibilities: · Complete case report forms (paper & electronic data capture) and address queries. · Submit documents to regulatory authorities (e.g., IRB, FDA) and/or review/monitoring boards (e.g., DSMB, independent safety officer). · Facilitate pre-study, site qualification, study initiation, and monitoring visits as appropriate. · Facilitate study close-out activities as appropriate. · Collect, process, and ship samples as applicable to the protocol. · Schedule subject visits and procedures. · Retain records/archive documents after study closeout. Education Qualifications: · Bachelor's Degree preferred. · Phlebotomy and/or Lab skills (MST, MSLT, etc) Experience Qualifications: · At least three (3) years of clinical research-related experience required. · Prior work in a medical clinic Compensation: $65,000.00 - $70,000.00 per year At Pace Foot and Ankle Centers, PLLC you are our most valuable asset! Our healthcare team is dedicated to the art and science of advanced foot and ankle treatments. Medicine and surgery are constantly evolving, and our physicians strive to stay current. Our goal is to incorporate our extensive training and knowledge into a rewarding healthcare experience. We value communication and teaching where our patients, who range from pediatric to geriatric, and their families are active participants in making decisions regarding their health and wellness. This business is independently owned and operated by the business owner. Your application will go directly to the business owner, and all hiring decisions will be made by the management of this business. All inquiries about employment at this business should be made directly to the business location, and not to PACE: Foot and Ankle Centers Corporate.