Clinical research associate jobs in Newberry, PA - 24 jobs

The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The SrCRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The SrCRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The SrCRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. The SrCSA performs all the duties of the CRA with higher proficiency, independency, accountability, and ability to take on additional tasks or tutor more junior personnel. A SrCRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD. **Key Accountabilities:** **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential): + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. - Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desirable):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as required. + Valid driving license per country requirements, as applicable \#LI-LO1 \#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.

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. 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

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

Full-time (80 hours biweekly) Weekdays, daytime hours and some evenings Coordinates clinical research activities and compliance to study requirements, and patient and staff considerations relative to specific clinical trials and/or studies. Monitors the clinical course and collection of research data for patients in clinical trials. Assists the medical investigators in achieving the objectives of clinical research studies and supports ongoing patient management approaches in the designated disease/treatment area(s). Considers nursing implications in areas of staff and patient educational needs, staff resources, and research objectives. Acts as a resource for clinical and support staff involved in the care of patients enrolled in appropriate studies. Coordinates and performs nursing responsibilities in specialty area(s) for clinical research patients. Essential Functions: * Participates in the review of research protocols and assesses the appropriateness, feasibility and resource requirements for implementation. Serves as the principle liaison for project, developing plans and tools as needed to conduct research. Performs nursing responsibilities for nursing care based on research study requirements. * Assists investigators in evaluating the quality of care and compliance to protocol requirements. Follows by ensuring compliance with all guidelines for human subject protection and research. * Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators, management, sponsors, and/or regulatory bodies. Ensures billing of study procedures to the appropriate funding source if needed. * Maintains an excellent working knowledge of all protocols. Develops and conducts formal and informal education to inform clinical and other staff of implications of protocol procedures. Distributes protocol and patient information in a timely manner. * Oversees patient pretreatment, eligibility and informed consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in research studies. Documents record of institutional patient registration. * Coordinates, observes and/or records data for protocol therapy. Monitors dosage modifications and actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses. * Evaluates and identifies potentially eligible protocol patients, and verifies according to protocol requirements. Provides direct patient education regarding protocol participation, and provides additional information as appropriate. Ensures the integrity of the informed consent process and assists in obtaining informed consent from patients. Works with internal and external registration and scheduling personnel as appropriate to facilitate study entry. * Coordinates, observes and/or records data for protocol therapy. Actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses. * Adheres to all protocol requirements to ensure validity of clinical research patient data. Submits complete and accurate forms and materials to external agencies as required in accordance with protocol requirements. * Coordinates protocol-related patient activities to ensure protocol compliance and optimal patient scheduling. Designs and compiles forms and educational materials to aid physicians and staff in complying with protocol requirements including tests and follow up visits. * Monitors and facilitates necessary documentation in the conduct of clinical research studies. Regularly reviews protocol study forms for accuracy and compliance to protocol standards. Performs consistency checks, edits for errors, and monitors timeliness of data submission. Identifies system inadequacies and augments the system as necessary. * Prepares and/or processes adverse event reports on protocol patients and submits these to the principal investigator and appropriate agencies. Alerts investigators and appropriate personnel of communications received regarding adverse events or drug reaction reports or investigational device related issues. * Oversees the receipt, secure storage and dispensing of medications provided for protocol patients. Reviews investigational drug logs and inventories to assure that appropriate documentation is maintained and federal guidelines are met. * Coordinates all site visit audits. Gathers records and other necessary materials required for audits. Reviews records with all site visit teams and responds to audit reports in a timely manner. * Develops and maintains effective and ongoing communication with clinical research participants, the Sponsor and PI. Acts as a liaison between national cooperative groups, institutional investigators, staff and affiliate groups. * Triages patient calls, attending to or resolving problems and answering questions. * Suggests improved methods for accomplishing research goals. * Remains flexible with scheduling to ensure that active research trials and clinical research participants are covered. * Travels to additional WellSpan sites as required to execute trials. * Attends and participates in research team meetings; educational research and clinically relevant workshops to maintain skill set, knowledge base and continuing educational credits. Common Expectations: * Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research/Human Subjects Protection Administrator, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to insure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research/Human Subject Protection Administrator and the appropriate Service Line Leader. * Demonstrates knowledge of the principles of growth and development over the life span of the assigned patient population. Assesses and interprets patient age specific data and provides appropriate, age specific treatment. Provides direct patient care to assigned patient age group(s). * Provides outstanding service to all customers; fosters teamwork; and practices fiscal responsibility through improvement and innovation. * Attends meetings as required. Minimum Education: * Bachelor's Degree Required * Master's Degree Preferred Work Experience: * 2 years' experience in nursing, medical research, or clinical trials required and * Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research required Licenses: * Licensed Registered Nurse Upon Hire Required or * Registered Nurse Multi State License Upon Hire Required and * Heartsaver CPR/AED Upon Hire Required * Certified Clinical Research Coordinator Upon Hire Preferred or * Certified Clinical Research Professional Upon Hire Preferred Courses and Training: * Appropriate RN specialty certification. Upon Hire Preferred Benefits Offered: * Comprehensive health benefits * Flexible spending and health savings accounts * Retirement savings plan * Paid time off (PTO) * Short-term disability * Education assistance * Financial education and support, including DailyPay * Wellness and Wellbeing programs * Caregiver support via Wellthy * Childcare referral service via Wellthy For additional details: Benefits & Incentives | WellSpan Careers (joinwellspan.org) Please submit your resume and outline the names of the research trials which you have worked with in the past. WellSpan Health's vision is to reimagine healthcare through the delivery of comprehensive, equitable health and wellness solutions throughout our continuum of care. As an integrated delivery system focused on leading in value-based care, we encompass more than 2,300 employed providers, 250 locations, nine award-winning hospitals, home care and a behavioral health organization serving central Pennsylvania and northern Maryland. Our high-performing Medicare Accountable Care Organization (ACO) is the region's largest and one of the best in the nation. With a team 23,000 strong, WellSpan experts provide a range of services, from wellness and employer services solutions to advanced care for complex medical and behavioral conditions. Our clinically integrated network of 3,000 aligned physicians and advanced practice providers is dedicated to providing the highest quality and safety, inspiring our patients and communities to be their healthiest.

Apply now Penn State Health - Hershey Medical Center Work Type: Full Time FTE: 1.00 Shift: Day Hours: 8-hour shifts Recruiter Contact: Denisse M. Rosado at [email protected] The Research RN will plan, direct, or coordinate clinical research projects. The Research RN will direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. The research nurse may evaluate and analyze clinical data. The Research RN will monitor study activities to ensure compliance with protocols and will all relevant local, federal and state regulatory and institutional policies. MINIMUM QUALIFICATION(S): * Bachelor's degree in Nursing or equivalent required. * Two (2) years effective experience required. * Currently licensed to practice as a Registered Nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact required. * AHA BLS prior to end of orientation period. PREFERRED QUALIFICATION(S): * Experience in a clinical research setting preferred 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

**Penn State Health** - **Hershey Medical Center** **Work Type:** Full Time **FTE:** 1.00 **Shift:** Day **Hours:** 8-hour shifts **Recruiter Contact:** Denisse M. Rosado at ******************************** (MAILTO://********************************) **SUMMARY OF POSITION:** The Research RN will plan, direct, or coordinate clinical research projects. The Research RN will direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. The research nurse may evaluate and analyze clinical data. The Research RN will monitor study activities to ensure compliance with protocols and will all relevant local, federal and state regulatory and institutional policies. **MINIMUM QUALIFICATION(S):** + Bachelor's degree in Nursing or equivalent required. + Two (2) years effective experience required. + Currently licensed to practice as a Registered Nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact required. + AHA BLS prior to end of orientation period. **PREFERRED QUALIFICATION(S):** + Experience in a clinical research setting preferred **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** Coordinator Clinical Research I - DAY SHIFT - Clinical Heart and Vascular Cardio Research **Location** US:PA: Hershey | Nursing | Full Time **Req ID** 68506

This job manages physician preference items (PPI) at Allegheny Health Network in the Neurosurgical and Orthopedic categories. The awarded candidate is responsible for developing specialty specific physician panels to drive product and process decisions throughout the network. Following the contract creation process, the incumbent ensures that compliance levels are maintained for select PPI contracts as well as supports Provider Supply Chain Partner's business development. Additionally, the incumbent is responsible for generating savings opportunities to contribute to supply chain's annual savings goal. **ESSENTIAL RESPONSIBILITIES** + Build relationships with physicians and clinical staff within the service line to manage a broad based group of contract categories. As the liaison between the vendors and the physicians/staff, work with the vendors to ensure that they are providing the proper training and support for the procedures. Follow regular call pattern with physicians to enhance engagement. + Partner with the physician panel members to develop PPI contracts, work through requests for new technologies and support resolution of any product issues across their practice. + Drive compliance and standardization across the service line within partner organizations working with physicians to ensure proper usage of on-contract products. + Support clinical contracting across a broad based group of contract categories to reach savings goals by facilitating clinician involvement in decision making. + Meet with senior leadership throughout partner organizations to discuss conversion and/or implementation plans, financial impact, as well as clinical perspective. + Support business development for Provider Supply Chain Partners by serving as the clinical expert to help drive contract penetration at the affiliate hospitals. + Train and mentor other Clinical Integration Coordinators on the team to help them work through the contracting process and any compliance concerns. + Other duties as assigned. **EDUCATION** **Required** + Bachelors Degree in Business Administration/Management **Substitutions** + Any applicable (Bachelors or Higher) degree may be substituted for a degree in management **Preferred** + None **EXPERIENCE** **Required** + 7 - 10 years in the Healthcare Industry + 3 - 5 years in Sales **Preferred** + 3 - 5 years in Medical Sales + 1 - 3 years in Clinical Services **LICENSES OR CERTIFICATIONS** **Required** + None **Preferred** + None **SKILLS** + Relationship-builder with Unsurpassed Interpersonal Skills + Building and Leading Teams + Communication Skills + Continuous Improvement + Cost Saving Initiatives + Excellent Multi-Tasker + Leading Effective Meetings + Creative Problem Solving + Analytical and Logical Reasoning/Thinking **Languages (other than English)** None **Travel Requirement** 50% - 75% **PHYSICAL, MENTAL DEMANDS and WORKING CONDITIONS** **Position Type** Remote Teaches / trains others regularly Occasionally Travel regularly from the office to various work sites or from site-to-site Frequently Works primarily out-of-the office selling products/services (sales employees) Never Physical work site required Yes Lifting: up to 10 pounds Does Not Apply Lifting: 10 to 25 pounds Does Not Apply Lifting: 25 to 50 pounds Does Not Apply **_Disclaimer:_** _The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job._ **_Compliance Requirement:_** _This position adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies._ As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times. In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company's Handbook of Privacy Policies and Practices and Information Security Policy. Furthermore, it is every employee's responsibility to comply with the company's Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements. **Pay Range Minimum:** $67,500.00 **Pay Range Maximum:** $126,000.00 _Base pay is determined by a variety of factors including a candidate's qualifications, experience, and expected contributions, as well as internal peer equity, market, and business considerations. The displayed salary range does not reflect any geographic differential Highmark may apply for certain locations based upon comparative markets._ Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on any category protected by applicable federal, state, or local law. We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact the email below. For accommodation requests, please contact HR Services Online at ***************************** California Consumer Privacy Act Employees, Contractors, and Applicants Notice Req ID: J270477

Posting Date 11/24/2025 1695 Roosevelt AveSuite A, York, Pennsylvania, 17408-8521, United States of America DaVita is hiring a Clinical Coordinator to lead outpatient dialysis care for patients with end-stage renal disease. In this role, you'll oversee treatment, guide clinical staff, and ensure the highest standards of care and safety. Key Responsibilities: * Coordinate patient care plans and monitor outcomes * Supervise clinical staff, including PCTs * Ensure safe, compassionate dialysis delivery * Build long-term relationships with patients and families * Work in a fast-paced, team-oriented environment Requirements: * Current RN license and CPR certification * 18+ months RN experience, including 6+ months dialysis * Charge RN readiness approval required * ADN required; BSN preferred * ICU, ER, or Med/Surg experience preferred * CNN/CDN certification a plus * Basic computer skills (MS Word, Outlook) * Flexible schedule, including weekends and holidays What We Offer: * Medical, dental, vision, 401(k) match * PTO and PTO cash-out * Paid training and development * Family and mental health support (Headspace, EAP, child/elder care) Ready to lead and make a difference? Apply now. #LI-AF1 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.

This position provides research project support to requesting department to ensure timelines and effectiveness in activation and completion of needed research projects. Responsible for routine to moderately complex project coordination / project management as well as communication and documentation as required by the research departments. **Please note that a video interview through Microsoft Teams will be required as well as potential onsite interviews and meetings** We are committed to offering flexible work options where approved and stated in the job posting. However, we are currently not considering candidates who reside or plan to reside in the following states: **California, Connecticut, Hawaii, Illinois, New York, Rhode Island, Vermont, and Washington** **Essential Functions** + **Research Support and Administration:** Support various clinical research studies and departments across the Intermountain system. Based on role, may coordinate (1) review of IRB/HRPP submissions and provide support to research oversight committees and research programs, coordinate review and oversee submission, or (2) centralized administrative and technical functions associated with grants, contracts and other agreements from external funding sources. + **Project Planning & Execution:** Define, develop, and execute clinical research project plans, including work plans and schedules. Identify needed resources, roles, and responsibilities for assigned studies. Facilitate feedback from key participants and participate as a team member when needed. + **Budget & Scope Management:** Develop comprehensive budget and scope documents for clinical research studies. Assist with business case and proposal development, including budget preparation and completion of required forms for internal and external routing. + **Study Requirements & Compliance:** Analyze study requirements to ensure sponsor and study requirements are met. Communicate impacts on existing studies to internal and external stakeholders. Look for cost-effective methods to facilitate study execution while meeting functional and regulatory requirements. + **Quality Assurance & Documentation:** Participate in quality assurance plans and reviews as requested. Document clinical research study deliverables, track and communicate timelines, and prepare reports and presentations on findings. Ensure completion of deliverables per specified deadlines. Support research billing by reviewing research accounts and reconciling invoices. + **Study Lifecycle Management:** Manage study startup, maintenance, and closeout activities. Provide support and guidance to Clinical Research study teams on study financials, and act as a source expert and liaison. As requested, provide support and back up as clinical research coordinator. + **Medicare Coverage Analysis:** Support the development of Medicare Coverage Analysis for clinical trials. Draft and prepare coverage analysis documents, review reimbursement guidelines, ensure correct billing, and provide coverage review. + **Auditing & Risk Management:** Coordinate project assessments and response planning. Communicate risks, develop and execute strategies, and lead auditing activities to ensure compliance with guidelines and regulations. **Skills** + Budgeting + Financial negotiation + Attention to detail + Multitasking + Clear written and verbal communication + Task Prioritization + Process Improvement + Critical thinking + Collaboration + Research **Physical Requirements** + Ongoing need for employee to see and read information, labels, monitors, etc. and to see to identify equipment and supplies and to utilize a wide variety of information including organizing and completing documentation and forms, accessing and entering computer information, and identifying needs and urgent issues. + Frequent interactions with providers, colleagues, customers, patients/clients, and visitors that require employee to verbally communicate as well as hear and understand spoken information, needs, and issues quickly and accurately. + Manual dexterity of hands and fingers to manipulate complex and delicate equipment with precision and accuracy. This includes frequent computer use and typing for documenting patient interactions, accessing needed information, operating telephones and other office equipment, including manipulating paper - requiring the ability to move fingers and hands. + Expected to bend, lift, and carry patient files, documents, equipment, and supplies. + Remain sitting or standing for long periods of time while interacting with others or to perform work on a computer, telephone, or other equipment. + For roles requiring driving: Expected to drive a vehicle which requires sitting, seeing and reading signs, traffic signals, and other vehicles. **Physical Requirements:** **Minimum Qualifications** + Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills; Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills: Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment. + Demonstrated experience working in a collaborative team environment. + Experience using word processing, spreadsheet, database, internet, e-mail, and scheduling applications. + Ability and willingness to travel within the Intermountain system and work from different locations as assigned. Occasional overnight travel may be required. + Clinical licensure, experience or certification may be required due to grant funding requirements. · Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified. + Two (2) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **OR** + Three (3) years of experience in a research or relevant healthcare/business role requiring strong demonstrated attention to detail and ability to adhere to policies and procedures. **Preferred Qualifications** + Experience in clinical research setting, including relevant study management experience. · Experience in a healthcare or hospital setting. **Location:** Intermountain Health Intermountain Medical Center **Work City:** Murray **Work State:** Utah **Scheduled Weekly Hours:** 40 The hourly range for this position is listed below. Actual hourly rate dependent upon experience. $27.65 - $43.55 We care about your well-being - mind, body, and spirit - which is why we provide our caregivers a generous benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged. Learn more about our comprehensive benefits package here (***************************************************** . Intermountain Health is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At Intermountain Health, we use the artificial intelligence ("AI") platform, HiredScore to improve your job application experience. HiredScore helps match your skills and experiences to the best jobs for you. While HiredScore assists in reviewing applications, all final decisions are made by Intermountain personnel to ensure fairness. We protect your privacy and follow strict data protection rules. Your information is safe and used only for recruitment. Thank you for considering a career with us and experiencing our AI-enhanced recruitment process. All positions subject to close without notice.

**UPMC is hiring a Clinical Transplant Coordinator! This is a full time, day shift position with an on call and weekend rotation required, and those with ED and Critical Care experience are encouraged to apply! Travel to other sites within PA throughout the month is required.** **Purpose:** This Clinical Transplant/VAD Coordinator I has the authority, responsibility, and accountability for the delivery of nursing care through the use of the nursing process. The Clinical Transplant/VAD Coordinator I, in collaboration with Clinical Transplant/VAD Coordinators IIs, Supervisor, Clinical Transplant/VAD Coordinators, the transplant/VAD team and other health care professionals, applies competent clinical knowledge and skills to achieve quality care outcomes. The Clinical Transplant/VAD Coordinator I must demonstrate the entry-level knowledge and skills necessary to provide care that is relevant to patients under their care, as well as apply principles of growth and development over the life span. The Clinical Transplant/VAD Coordinator I also must possess the ability to assess and interpret patient data needed to identify each patient's requirements relative to his or her age specific needs. **Responsibilities:** + TRANSPLANT/VAD REFERRAL AND EVALUATION1. Identifies appropriate transplant/VAD candidates upon referral and interacts with appropriate hospital staff.2. Identifies requirements for candidate evaluation.3. Coordinates the evaluation process for potential transplant/VAD candidates with the multidisciplinary team.4. Functions as candidate advocate by applying knowledge of growth, development, educational and cultural background during candidate and family interaction.5. Provides data to regulatory agencies.6. Demonstrates knowledge of compliance with United Network for Organ Sharing (UNOS) policies and listing requirements. + POST-TRANSPLANT/VAD OUT-PATIENT PERIOD21. Identifies and responds to recipient and family needs in post-transplant/VAD phase.22. Reinforces educational and follow-up requirements.23. Collects and reviews data pertinent to recipient's health and organ function.24. Provides and maintains comprehensive documentation of recipient's progress.25. Implements changes in drug therapy as ordered by physician.26. Arranges for consultations, diagnostic procedures, and hospitalization when indicated.27. Maintains communication with referring physician and other health care providers.28. Assesses recipient's compliance with medications and medical regime; collaborates with transplant/VAD team to attain and maintain compliance. + POST-TRANSPLANT/VAD IN-PATIENT PERIOD18. Monitors patient progress post-transplant.19. Educates recipient and family regarding care and responsibilities after transplantation.20. Collaborates with transplant/VAD team to establish and implement patient plan of care. + PROFESSIONAL GROWTH AND DEVELOPMENT29. Obtains ABTC Certification.30. Attends practice-related conferences.31. Participates in educational and outreach activities. 32. Constructively receives feedback and direction.33. Identifies and communicates learning needs to manager. 34. Takes action to improve knowledge, skills and performance based on feedback or on self-identified developmental needs.35. Participates in self-review as requested by manager.36. Responsible for adhering to On-Call schedule. + PERI-OPERATIVE PERIOD13. Participates in transplant/VAD process according to UPMC protocol.14. Reviews potential recipient's current medical status to determine eligibility for transplant.15. Facilitates admission or transfer to UPMC.16. Communicates with organ procurement agency/ORC and collects the appropriate data necessary for decision making re organ acceptance/rejection for transplant as applicable.17. Exhibits ability to remove transplant recipient from the list per UNOS regulations as applicable. + PRE-TRANSPLANT/VAD PERIOD7. Develops and institutes a teaching plan addressing transplant/VAD candidates learning needs.8. Maintains communication with patient and referring physician.9. Recognizes potential problems and/or significant changes during the waiting period and coordinates required care.10. Acts as a resource person for internal and external health care providers.11. Provides and maintains comprehensive documentation of candidate process.12. Exhibits ability to maintain and update candidate listing status per UNOS regulations as applicable. 2 years recent clinical nursing experience. Demonstrated competence in professional nursing practice. Diploma or Associates Degree in Nursing. BSN preferred. Must obtain a Solid/Strong/Good or higher on annual performance review to be promoted to Clinical Transplant/VAD Coordinator II. **Licensure, Certifications, and Clearances:** Current Pennsylvania licensure as a Registered Professional Nurse. It is preferred that within 2 years employee will obtain and maintain certification from the American Board for Transplant Certification (ABTC) as a Certified Clinical Transplant Coordinator (CCTC), CHFN (Certified Heart Failure Nurse), or other UPMC approved certification associated with the service line upon eligibility in order to be promoted to Clinical Transplant Coordinator II. + Advanced Cardiac Life Support (ACLS) + Registered Nurse (RN) + Act 34 *Current licensure either in the state where the facility is located or, if the facility is in a state covered by the multistate Nursing Licensure Compact (NLC) agreement, a multistate license issued by a participating NLC state. Hires and current employees working on an out-of-state NLC license who later change their residency to the state where the facility is also located will have 60 days upon changing their residency to apply for licensure within that state. **UPMC is an Equal Opportunity Employer/Disability/Veteran**

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#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.

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. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. 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_

Job DescriptionDescription: 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

**Penn State Health** - **Hershey Medical Center** **Work Type:** Full Time **FTE:** 1.00 **Shift:** Day **Hours:** 8-hour shifts **Recruiter Contact:** Denisse M. Rosado at ******************************** (MAILTO://********************************) **SUMMARY OF POSITION:** Responsible for the facilitation, coordination and implementation of clinical research protocols under physician investigator guidance and delegation, including liaison with faculty and external sponsors/agencies, patient management and education, budget review and quality management. **MINIMUM QUALIFICATIONS:** Bachelor's degree in Nursing or Master's degree in Nursing required. 2 years clinical experience as an RN required. 2 years clinical research experience required. Currently licensed to practice as a Registered Nurse by state of employment or holds a multistate RN license through the interstate Nurse Licensure Compact. Research certification (SoCRA or ACRP) required. If not certified, must be willing to pursue and obtain certification within six months. **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** Coordinator Clinical Research II - DAY SHIFT - Clinical Heart and Vascular Cardio Research **Location** US:PA: Hershey | Nursing | Full Time **Req ID** 68507

Full-time (80 hours biweekly) Weekdays, daytime hours Hybrid Work Options Designs, coordinates and conducts designated research activities and provides related education, resources and consultation for staff members. Manages a system for planning, organizing and controlling workflow of clinical studies approved for implementation. Adheres to regulatory guidelines and ensures timely, complete and accurate reporting of sensitive and confidential patient information. Has regular contact with physicians, health care personnel and patients. Assists resident physicians with required scholarly activity (Institutional Review Board (IRB) submission, presentations, manuscripts). Essential Functions: * Works collaboratively with and/or assists physicians, residents and related healthcare providers in the planning, coordinating, implementation and completion of research studies, clinical studies and/or multi-center clinical trials, and other scholarly activities. * Recruits and screens subjects for research studies. Collects baseline and follow up data from subjects. Checks for validity and accuracy of data ensuring compliance with quality assurance requirements and clinical relevance. * Acts as a resource for researchers by providing literature searches, assistance in research design, coding and abstracting data, computer data entry, media production and IRB submission. * Assists researchers in preparing presentations and publications, as well as, contributing authorship to portions of manuscripts. * Ensures that research activities comply with safety, professional, organizational and federal standards and/or regulations. * Coordinates research activities in designated area and ensures efficient use of time, equipment, personnel and other resources to achieve objectives. * Instructs students and novice researchers in proper research techniques and procedures. * Maintains a working knowledge of all research protocols. Transmits and distributes protocol information, including protocol amendments, to the Institutional Review Board (IRB), physicians and staff members. Serves as a senior non-medical resource for protocol and clinical research information. * Adheres to all protocol requirements to ensure validity of clinical research patient data. Coordinates activities of clinical studies/trials and ensures adherence to the protocol by all personnel involved. * Collects or ensures that all pertinent and required data is properly abstracted and recorded on data collection forms for each study subject. * Creates and maintains patient database to ensure all data time points are captured. Designs and distributes materials which aid physicians and other staff members in complying with protocol requirements and patient enrollment. * Meets regularly with principal investigators of studies to review data accuracy and overall study progress. Identifies areas for improvement and initiates corrective action. * Prepares reports on individual patients as required by the study sponsor and/or the principal investigator. Prepares and/or processes adverse event reports on patients enrolled in studies and submits to the principal investigator, the IRB, study sponsors and appropriate agencies. * Educates staff of affiliate departments as needed to conduct clinical trials and seeks to develop and maintain a working relationship with affiliates. * Prepares for and participates in audits of studies, both by internal and external parties. In conjunction with the principal investigator, writes audit summary and reports and develops/coordinates corrective action plans as needed. * Under the direction of the principal investigator, prepares new study requests and protocol consent modifications to be sent to the IRB. Prepares annual protocol renewal requests and termination reports for the principal investigator. Common Expectations: * Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research Clinical Operations, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to ensure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research Clinical Operations and the appropriate Service Line Leader. * Provides outstanding service to all customers; fosters teamwork; and practices fiscal responsibility through improvement and innovation. Minimum Education: * Bachelor's Degree Required * Master's Degree Preferred Work Experience: * 2 years Clinical research or nursing experience required and * Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research. Required Licenses: * Certified Clinical Research Coordinator within 2-1/2 years Required or * Certified Clinical Research Professional within 2-1/2 years Required Knowledge, Skills, and Abilities: * Excellent organizational skills. * Ability to follow multiple, detailed directions of various research protocols. * Knowledge of medical terminology. * Excellent oral and written communication skills. * Ability to work independently. * Comprehensive knowledge of clinical research principles, regulations and guidelines. * Comprehensive knowledge of research design, basic statistics, and the responsible conduct of research. * Ability to assist in training and day- to-day oversight of subordinate personnel. * Excellent computer skills including word processing, spreadsheet, relational database, project management, statistical and graphics software. Benefits Offered: * Comprehensive health benefits * Flexible spending and health savings accounts * Retirement savings plan * Paid time off (PTO) * Short-term disability * Education assistance * Financial education and support, including DailyPay * Wellness and Wellbeing programs * Caregiver support via Wellthy * Childcare referral service via Wellthy For additional details: Benefits & Incentives | WellSpan Careers (joinwellspan.org) WellSpan Health's vision is to reimagine healthcare through the delivery of comprehensive, equitable health and wellness solutions throughout our continuum of care. As an integrated delivery system focused on leading in value-based care, we encompass more than 2,300 employed providers, 250 locations, nine award-winning hospitals, home care and a behavioral health organization serving central Pennsylvania and northern Maryland. Our high-performing Medicare Accountable Care Organization (ACO) is the region's largest and one of the best in the nation. With a team 23,000 strong, WellSpan experts provide a range of services, from wellness and employer services solutions to advanced care for complex medical and behavioral conditions. Our clinically integrated network of 3,000 aligned physicians and advanced practice providers is dedicated to providing the highest quality and safety, inspiring our patients and communities to be their healthiest.

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 the Sponsor's 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. **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 the Sponsor's 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 Site Care Partner 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 Site Care Partner 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 the Sponsor's credibility, scientific leadership and in order to facilitate their 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 **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#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.

Full-time (80 hours biweekly) Weekdays, daytime hours Hybrid Work Options Designs, coordinates and conducts designated research activities and provides related education, resources and consultation for staff members. Manages a system for planning, organizing and controlling workflow of clinical studies approved for implementation. Adheres to regulatory guidelines and ensures timely, complete and accurate reporting of sensitive and confidential patient information. Has regular contact with physicians, health care personnel and patients. Assists resident physicians with required scholarly activity (Institutional Review Board (IRB) submission, presentations, manuscripts). **Essential Functions:** + Works collaboratively with and/or assists physicians, residents and related healthcare providers in the planning, coordinating, implementation and completion of research studies, clinical studies and/or multi-center clinical trials, and other scholarly activities. + Recruits and screens subjects for research studies. Collects baseline and follow up data from subjects. Checks for validity and accuracy of data ensuring compliance with quality assurance requirements and clinical relevance. + Acts as a resource for researchers by providing literature searches, assistance in research design, coding and abstracting data, computer data entry, media production and IRB submission. + Assists researchers in preparing presentations and publications, as well as, contributing authorship to portions of manuscripts. + Ensures that research activities comply with safety, professional, organizational and federal standards and/or regulations. + Coordinates research activities in designated area and ensures efficient use of time, equipment, personnel and other resources to achieve objectives. + Instructs students and novice researchers in proper research techniques and procedures. + Maintains a working knowledge of all research protocols. Transmits and distributes protocol information, including protocol amendments, to the Institutional Review Board (IRB), physicians and staff members. Serves as a senior non-medical resource for protocol and clinical research information. + Adheres to all protocol requirements to ensure validity of clinical research patient data. Coordinates activities of clinical studies/trials and ensures adherence to the protocol by all personnel involved. + Collects or ensures that all pertinent and required data is properly abstracted and recorded on data collection forms for each study subject. + Creates and maintains patient database to ensure all data time points are captured. Designs and distributes materials which aid physicians and other staff members in complying with protocol requirements and patient enrollment. + Meets regularly with principal investigators of studies to review data accuracy and overall study progress. Identifies areas for improvement and initiates corrective action. + Prepares reports on individual patients as required by the study sponsor and/or the principal investigator. Prepares and/or processes adverse event reports on patients enrolled in studies and submits to the principal investigator, the IRB, study sponsors and appropriate agencies. + Educates staff of affiliate departments as needed to conduct clinical trials and seeks to develop and maintain a working relationship with affiliates. + Prepares for and participates in audits of studies, both by internal and external parties. In conjunction with the principal investigator, writes audit summary and reports and develops/coordinates corrective action plans as needed. + Under the direction of the principal investigator, prepares new study requests and protocol consent modifications to be sent to the IRB. Prepares annual protocol renewal requests and termination reports for the principal investigator. **Common Expectations:** + Is knowledgeable of and complies with institutional research policies, procedures and guidelines. With the oversight of the Director of Research Clinical Operations, has knowledge of and complies with governmental regulations regarding responsible conduct of research, research ethics and integrity and protection of the safety and welfare of human subjects (i.e., DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as applicable, such as those governing specimen banks, genetic research, etc.). Instructs less experienced personnel and advises others to ensure that research is conducted safely and in compliance with the above. Reports apparent or potential problems to the Director of Research Clinical Operations and the appropriate Service Line Leader. + Provides outstanding service to all customers; fosters teamwork; and practices fiscal responsibility through improvement and innovation. **Minimum Education:** + Bachelor's Degree Required + Master's Degree Preferred **Work Experience:** + 2 years Clinical research or nursing experience required and + Training/experience in the responsible conduct of research, including medical/ research ethics and protection of the safety and welfare of human subjects in research. Required **Licenses:** + Certified Clinical Research Coordinator within 2-1/2 years Required or + Certified Clinical Research Professional within 2-1/2 years Required **Knowledge, Skills, and Abilities:** + Excellent organizational skills. + Ability to follow multiple, detailed directions of various research protocols. + Knowledge of medical terminology. + Excellent oral and written communication skills. + Ability to work independently. + Comprehensive knowledge of clinical research principles, regulations and guidelines. + Comprehensive knowledge of research design, basic statistics, and the responsible conduct of research. + Ability to assist in training and day- to-day oversight of subordinate personnel. + Excellent computer skills including word processing, spreadsheet, relational database, project management, statistical and graphics software. **Benefits Offered:** + Comprehensive health benefits + Flexible spending and health savings accounts + Retirement savings plan + Paid time off (PTO) + Short-term disability + Education assistance + Financial education and support, including DailyPay + Wellness and Wellbeing programs + Caregiver support via Wellthy + Childcare referral service via Wellthy For additional details: Benefits & Incentives | WellSpan Careers (joinwellspan.org) (*************************************** WellSpan Health's vision is to reimagine healthcare through the delivery of comprehensive, equitable health and wellness solutions throughout our continuum of care. As an integrated delivery system focused on leading in value-based care, we encompass more than 2,300 employed providers, 250 locations, nine award-winning hospitals, home care and a behavioral health organization serving central Pennsylvania and northern Maryland. Our high-performing Medicare Accountable Care Organization (ACO) is the region's largest and one of the best in the nation. With a team 23,000 strong, WellSpan experts provide a range of services, from wellness and employer services solutions to advanced care for complex medical and behavioral conditions. Our clinically integrated network of 3,000 aligned physicians and advanced practice providers is dedicated to providing the highest quality and safety, inspiring our patients and communities to be their healthiest. **Quality of Life** Founded in 1741, the city of York is considered by many as the first capital of the United States. The Articles of Confederation were signed by the Second Continental Congress here in 1777. Its beautifully restored historic district is an architectural treasure. While York retains its farming and manufacturing heritage, at its heart York is a thriving cultural community that has attracted creative talent and innovative entrepreneurial investors from across the nation. Life in York County offers affordable housing, options for higher education, a thriving arts and cultural community, historical attractions, parks and recreational resources, semi-professional baseball team, fine dining and more - within an easy drive of major East Coast cities. York County residents can find local employment in healthcare, manufacturing, technology, agricultural and service sectors. (Patient population: 445,000) WellSpan Health is an Equal Opportunity Employer. It is the policy and intention of the System to maintain consistent and equal treatment toward applicants and employees of all job classifications without regard to age, sex, race, color, religion, sexual orientation, gender identity, transgender status, national origin, ancestry, veteran status, disability, or any other legally protected characteristic.

**Penn State Health** - **Hershey Medical Center** **Work Type:** Full Time **FTE:** 1.00 **Shift:** Day **Hours:** Monday - Friday 8:00a - 4:30p **Recruiter Contact:** Hector Diaz at ****************************** (MAILTO://******************************) **SUMMARY OF POSITION:** Responsible for assessing staffing needs based on information gathered from a variety of sources, obtaining additional staffing resources as needed, and assuring that staffing resources and unit needs are appropriately matched on a weekly, daily, and shift basis. **MINIMUM QUALIFICATION(S):** + High school diploma or equivalent required. + Two (2) years of experience required. + Act 31 training completion required within 45 days of hire. **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** Coordinator Clinical Staffing - Orthopaedics **Location** US:PA: Hershey | Clerical and Administrative | Full Time **Req ID** 87060