Clinical Research Coordinator Jobs in West Seneca, NY

EPM is partnered with a clinical-stage biotech company that is creating innovative therapeis to treat patients with unmet medical needs in the Autoimmune, Fibrotic, and CNS space. With multi million dollar partnerships with peers in the industry, this opportunity offers an interesting blend of financial runway and room for growth. Their leadership has a proven track record of getting drugs to market and builiding high performance companies as well. Responsibilities Serve as the lead clinical scientist on the trial team, overseeing specific aspects of clinical and scientific execution for clinical protocols Help in developing program strategy including clinical development plan and generate KOL relationships Work cross functionally with various departments to develop protocols and related study materials (e.g., informed consent forms, amendments), and coordinate with Clinical Operations on study deliverables Ensure case report forms (CRFs) are designed to align with protocol requirements, working closely with Clinical Data Management and Programming Collaborate across functions to monitor clinical data, ensuring the quality, completeness, and integrity of trial conduct Qualifications 12+ years of experience with a Bachelor's degree, or 10+ years with a postgraduate degree Experience in clinical drug development, or a PhD, Pharm D, or RN degree is preferred Strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH) Ability to manage multiple priorities with effective planning, time management, and prioritization skills Strong analytical skills to interpret clinical trial data and draw conclusions Scientific expertise to propose, design, and execute clinical research and development studies, and author documents related to clinical trials (e.g., medical monitoring plans, statistical analysis plans, informed consent forms, clinical study reports) Ability to interact with key stakeholders across Clinical Development functional areas Proactive approach, strategic thinking, and leadership in driving clinical study goals Benefits Medical Dental Vision

Physician Affiliate Group of New York (PAGNY) at Lincoln Medical Center, a leading community hospital in the South Bronx, is seeking a Board-Certified/Board-Eligible Hematologist-Oncologist to serve as the Director of Clinical Oncology Research. This role combines clinical excellence, leadership in oncology research, and teaching responsibilities in a dynamic academic environment. The Director will lead and expand clinical trials and translational research programs while also providing compassionate patient care. New/Recent graduates are welcome. Lincoln Medical Center is affiliated with Weill Medical College of Cornell University. The Mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and has established the ICARE standards for all staff. NYC Health + Hospitals is the nation's largest municipal health care delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, and regardless of immigration status or ability to pay. The Hematology/Oncology division is part of the Department of Medicine. It provides adult inpatient consultations across the hospital and runs a busy hematology/oncology outpatient service and infusion center. Teaching & Mentorship: Work closely with Internal Medicine residents Oversee and mentor Hematology/Oncology fellows rotating from New York Medical College Position Highlights: Academic Appointment: Affiliation with Weill Cornell Medical College State-of-the-art facilities including a busy 11-chair infusion center Schedule & Call: Monday through Friday, 8-hour shifts On-call coverage is phone-based only Research & Clinical Balance: 0.3 FTE dedicated to cancer research 0.7 FTE dedicated to clinical Hematology/Oncology practice Participation in oncology clinical research required, with an opportunity to serve as the local Principal Investigator Qualifications MD/DO degree from an accredited institution. Board Certified / Eligible in Hematology-Oncology. Eligible for medical licensure in New York. Experience in clinical trials, translational oncology research, or investigator-initiated studies. Strong commitment to academic medicine, mentorship, and patient-centered cancer care. Preferred (not required): Track record of peer-reviewed publications and research funding. Experience in early-phase trials, immunotherapy, or precision oncology. Leadership experience in an academic or clinical research setting is preferred but not required. This position offers an attractive compensation & benefits package; excellent work/life balance; clinical research and teaching opportunities; flexible starting date and schedule; reasonable call schedule. Wages and Benefits include: Annual Base Salary: $375,000* based on 40-hour work week. Additional compensation available for extra call or sessional/per diem hours. The annual total value of the compensation package is estimated at $450,000**, which includes the baseline salary, 401(k) contribution, and other factors as set forth below: Projected bonus of up to $40,000 (based on previous year's average), contingent upon meeting quality and productivity targets. 401(k) Company Contribution (subject to IRS contribution limits): Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required. After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required. Annual Continuing Medical Education (CME) Reimbursement. Generous Annual Paid Time Off (PTO): Vacation, Sick, Holiday, and CME days. Medical, Prescription, and Dental Coverage: Top-tier plans with employee contributions significantly below market rates. Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 2x your salary (up to a maximum of $300,000) provided at no cost to you. Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family. Loan Forgiveness: Position may be eligible for loan forgiveness through certain state or federal programs. Medical Malpractice Coverage (equivalent to occurrence-based): Provided at no cost to the employee. Healthcare and Dependent Care Flexible Spending Accounts (FSAs). Pre-tax employee-paid contributions for commuting expenses. Visa sponsorship will be considered for this position. Physician Affiliate Group of New York, P.C. (PAGNY) mission is to provide accountable, responsive, quality care with the highest degree of sensitivity to the needs of the diverse population that lives in our New York Community. PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Our providers are highly skilled professionals with outstanding credentials who deliver the highest level of quality healthcare to patients throughout New York City. Physician Affiliate Group of New York, P.C. (PAGNY) is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. We are committed to fostering an inclusive environment where everyone feels valued and respected. Our policies ensure equal opportunities for all. Learn more about our initiatives by visiting our Diversity, Equity, and Inclusion page. *Salary Disclosure Information: The annual base salary listed complies with the New York City law on Salary Transparency in Job Advertisements. The annual base salary listed is for full-time employment and does not include bonuses/incentive compensation or benefits. Actual total compensation depends on many factors, including experience, specialties, historical productivity, and historical collections. **The annual total value of the compensation package shown is provided as an illustration and is not guaranteed. Apply for this opportunity Click the button below to visit our job portal and fill out an application for this opportunity. #J-18808-Ljbffr

The successful candidate will join the team of Dr. Grace Chan at Children's Hospital of Philadelphia. The Chan Lab is dedicated to advancing the survival and health of mothers, newborns, and children. Our research focuses on improving health outcomes in low-resource settings, particularly in the prevention and management of preterm and small babies, neonatal infections, and optimizing growth and development. The primary goal of our research program is to design, test, and scale interventions that prevent morbidity and early mortality among mothers and children worldwide. The Clinical Research Program Manager II at the Chan Lab is responsible for overseeing and managing a diverse portfolio of clinical and population health research projects aimed at improving health outcomes for mothers, newborns, and children, particularly in low-resource settings. This role involves managing multi-country clinical trials, epidemiologic studies, and collaborations with global partners; ensuring compliance with regulatory standards; and providing leadership and mentorship to research staff. It is anticipated that the CRPM will make multiple trips to Ethiopia to oversee the conduct of a clinical trial and meet with collaborators. The CRPM will be responsible for grant writing, financial management, and the preparation of reports for various stakeholders and should have experience in these areas. The ideal candidate will also have outstanding communication and relationship skills and experience with international public health research, project and program administration, and staff supervision. Additionally, the ability to be agile, assess the environment, and develop new programs is essential. The CRPM must also support and lead existing programs in reporting outcomes and activities in collaboration with key global health stakeholders. The expected breakdown of responsibilities would be as follows: 40% grant writing 40% program management (including clinical trial) 10% publication support (contributing to writing, submissions, coordinating co-authors) 10% communications - CHOP and external What you will do Direct and indirect supervision, training, support, and management of staff to ensure compliance with study protocol, NIH and FDA policies. Work collaboratively and effectively with the individual study management teams, various core groups at CHOP's Research Institute and other participating institutions. As part of Management Team, develop, review, and update program policies and procedures as needed. Serve as primary liaison between research and other hospital staff to carry out the needs of the research project(s). Assist with analysis of data and preparation of manuscripts and scientific presentations, as needed. Track regulatory compliance of CHOP and other sites. Oversee clinical trial budget preparations and billing plans and resolution of billing/budget issues. Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials. Provide supervision and support for other clinical research coordinators and or/ monitors who are assigned to specific protocols and who will help with the overall clinical research of the program. Provides a leadership role in developing, implementing, and evaluating the conduct of clinical research Responsible for Regulatory compliance for clinical research program. Critically evaluate decisions on staffing, finances, and regulatory needs for the study lifecycle. Additional responsibilities may include: Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports. Primary contact for trial for internal and external participants. Education Qualifications Bachelor's Degree Required Master's Degree in a related field Preferred Experience Qualifications At least eight (8) years of relevant & complex research experience - Required At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management - Required At least three (3) years of leadership, management or supervisory experience - Required At least ten (10) years of relevant & complex research experience - Preferred At least five (5) years of research administration or management experience, including budget administration, financial planning, and grants management - Preferred At least five (5) years of leadership, management or supervisory experience in a clinical research or academic environment - Preferred Skills and Abilities Excellent verbal and written communications skills Excellent interpersonal skills Excellent customer service skills Excellent time management skills Strong critical thinking / problem-solving skills Excellent project management skills Excellent organizational skills Excellent analytical skills Strong leadership skills Ability to maintain confidentiality and professionalism Ability to work independently with minimal supervision Ability to convey complex or technical information in an easy-to-understand manner Ability to collaborate with stakeholders at all levels Ability to be flexible and adaptable to change

Role Description This is a contract role for a Clinical Research Coordinator, located on-site in Bryn Mawr, Pennsylvania. The Clinical Research Coordinator will be responsible for managing the day-to-day clinical trial activities, obtaining informed consent from study participants, ensuring protocol adherence, conducting clinical research tasks, and managing clinical trial documentation. Qualifications Experience in obtaining Informed Consent and ensuring Protocol adherence Strong background in Research, with a focus on Clinical Research Experience Proficiency in managing Clinical Trials and related tasks Excellent organizational and documentation skills Ability to work collaboratively in an on-site environment Knowledge of regulatory requirements and GCP (Good Clinical Practice) guidelines Bachelor's degree in a related field or equivalent experience NOTE: This role will start at 20 hrs/week with ability to convert to full-time.

The United Health Services Clinical Coordinator is responsible and accountable for ensuring implementation of and compliance with all standards of practice and professional development in accordance with the New York State Nurse Practice Act, United Health Services Hospitals and Nursing Division policies, ANA Scope and Standards of Practice, Code of Ethics for Nurses, Joint Commission and the Bill of Patient Rights. The Clinical Coordinator supports the United Health Services Physician Practices as a liaison between the practices and United Health Services Nursing and Medical Group leadership. Works collaboratively with United Health Services Physician Practice leadership to manage clinical staffing to support safe patient care. CMH Walk-in - Days, 8 am - 5 pm #IND2 Primary Department or Work Location: UHS Walk-In Norwich Primary Work Shift: Scheduled Weekly Hours: 40 Compensation Range: $33.57 - $51.39 per hour, depending on experience - Education/Experience Minimum Required: Graduate of an accredited school of registered nursing. At least 3 years' experience in a health care setting with evidence of having obtained proficiency in those areas emphasized in the Registered Nurse curriculum. Preferred: Bachelor's degree in nursing Previous leadership and/or supervisory experience. Previous experience in a walk in / primary care/ specialty care setting. Knowledge of Joint Commission, NYS Department of Health, CMS and Article 28 standards. Working knowledge of Microsoft Word, Excel and PowerPoint programs. License/Certification Minimum Required: Current NY State RN license. CPR within 3 months of hire Preferred: Current driver's license. - Why You'll Love Working at UHS At United Health Services (UHS), we believe every connection-to patients, to purpose, to each other-makes a difference. That's why we're intentional about supporting our team in ways that go beyond the job. Whether through meaningful benefits, personal growth, or fun along the way, we're here to help you thrive in work and life. A Culture of Connection - We support each other like family and create space for every voice to be heard. Engagement Councils, peer recognition, and initiatives like Walk in my Shoes for senior leaders are just a few ways we foster belonging and collaboration. Outside of work, we stay connected through team events like trivia, trunk-or-treat, volunteer days, our staff choir, or seasonal celebrations. Comprehensive Benefits for Life & Family - We offer medical, dental, and vision coverage starting the first of the month after hire for employees working 24+ hours/week. With flexible plan options and coverage tiers, you can choose what fits your life best. Additional perks include discounted childcare through Bright Horizons and voluntary benefits like pet insurance, legal services, and identity theft protection. Well-Being & Financial Security - From day one, PTO starts accruing so you can take time to recharge. We support your long-term wellness with a 403(b) retirement plan and company match, flexible spending accounts, access to financial advisors, and up to $400/year in wellness rewards. When life gets tough, we're here with 24/7 EAP counseling, virtual mental health support, a food pantry, PTO donation program, and professional attire through the Classy Closet. Growth That Moves with You - With access to 100,000+ online courses, leadership programs, tuition reimbursement, clinical ladders, and internal mobility, we help you grow wherever your passion leads. We also continuously review compensation to ensure market competitiveness and internal equity, so you can feel confident your work is valued and rewarded fairly. A Place to Call Home - Located in New York's Southern Tier, UHS offers more than a career-we offer a lifestyle. Enjoy four-season recreation, affordable living, top-rated schools, minor league sports, craft brews, a close-knit community, and more, all within reach of the Finger Lakes, the Catskills, and major Northeast cities. - About United Health Services United Health Services (UHS) is a locally owned, not-for-profit healthcare system in New York's Southern Tier comprising four hospitals, long-term care and home care services, and physician practices in Broome and surrounding counties. UHS provides healthcare and medical services for two-thirds of the region's population, produces $1.3 billion a year in total economic impact, and boasts a workforce of more than 6,300 employees and providers. At UHS, our work is guided by our Values of Compassion, Trust, Respect, Teamwork, and Innovation. Whether you provide direct patient care or support behind the scenes, you are part of a shared purpose: to improve the health and well-being of the communities we serve. Every employee plays a meaningful role in fulfilling our mission-we'd love for you to consider joining us! United Health Services is an Equal Opportunity Employer. - United Health Services, Inc. and the members of the UHS System neither are affiliated with, sponsored, endorsed nor approved by, nor otherwise associated with, Universal Health Services, Inc. (NYSE: UHS), UHS of Delaware, Inc. nor their affiliates, which can be found at ***************

Department Precision Employment Type Full Time Location Manhattan, New York Workplace type Onsite Compensation $125,000 - $135,000 / year Key Responsibilities Skills, Knowledge and Expertise About Precision Neuroscience Precision is building a direct connection between the human brain and computers, to benefit the hundreds of millions of people worldwide suffering from neurological conditions. Established in 2021, we are a leader in the development and commercialization of brain-computer interfaces (BCI). As a Precision employee, you will be collaborating with experts across a diverse array of fields-including neurosurgery, mechanical engineering, machine learning, and microfabrication-to push the boundaries of what is possible. You will be joining a well capitalized and fast-moving company. In the two years since Precision's founding, we have built and validated a product and have begun human trials in partnership with some of the country's leading neurosurgery programs. And you will be working toward a deeply meaningful goal: restoring function to people living with devastating neurological conditions, including stroke, spinal cord injury, traumatic brain injury, and neurodegenerative disease such as ALS. Our platform will enable these individuals to regain independence, communicate with loved ones, and return to work.

Syndax Pharmaceuticals is looking for a Clinical Research Associate At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: Perform a key role in building relationships with site Clinical Coordinators, Study Investigators, and Service Provider partners and contribute significantly to the execution of the clinical trial. Collaborate with cross-functional team members in this high-profile role. Communicate regularly with CTMs regarding work progress. Apply knowledge of clinical site oversight and other monitoring activities as a co-monitor with contract CRAs and as a primary site monitor for study sites. Key Responsibilities: Assist in the development of information/consent forms. Assist in the development of study training materials, study plans and study tools. Review Monitoring Plans and monitoring visit reports. Track metrics for monitoring visits and monitoring visit reports and document trends. Conduct remote and on-site monitoring oversight visits as specified in the Oversight Plan for each assigned study. Work closely with Clinical Supplies to resolve outstanding site action items. If applicable, ensure study drug blind is maintained in all interactions with blinded study team members and site staff. Ensure the Monitoring Plan is followed. Perform in-house clinical study data review. Collect and review study site regulatory documents for study start-up, annual reviews, and study close-out. Create and maintain study-related tracking tools. Participate as needed in site study drug training (unblinded CRA role). Assist in the maintenance of the clinical trial master file; perform study file audits. Participate in QC of study documents (protocol, ICF template(s), TMF, etc.) and the UAT of EDC and IRT systems. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance, or support and coordinate with the CRO's CRAs on these activities. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audits, Health Authority Inspections and required follow-up actions. Daily interaction with Clinical Operations management and members of the cross-functional study team. Work with the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., CRO, Vendors, Regulatory, Investigator Sites, etc.). Lead and partake in regular team meeting/teleconferences; Participate/present at CRO, Vendor and Investigator Site meetings as necessary; Participate/present at Site and Investigator Meetings as necessary. Communicate any Site, CRO or Vendor escalations or issues to upper management as soon as identified. Desired Experience/Education and Personal Attributes: BS degree in life sciences or healthcare discipline, Master's degree is preferred; at least 3 years of clinical operations experience including at least 2 years of experience monitoring oncology trials preferred. Knowledge of good clinical practice (GCP) and FDA and ICH regulations and guidelines. Good verbal and written communication skills; enjoys frequent interaction with others. Able to prioritize tasks and work independently. Works collaboratively in a small team environment. Experience working with Risk-Based Monitoring and Centralized Monitoring Experience working with EMR, EDC, eTMF and CTMS systems. Able to travel an average of 25%, both domestically and internationally. Location: Syndax's corporate office is in New York, NY. Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $110,000 -$125,000. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit *************** or follow the Company on X (formerly Twitter) and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-remote

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

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

**Penn State Health** - **Hershey Medical Center** **Work Type:** **Temporary** **FTE:** 1.00 **Shift:** Varied **Hours:** 8-hour shifts **Recruiter Contact:** Denisse M. Rosado at ******************************** (MAILTO://********************************) **SUMMARY OF POSITION:** Responsible for the implementation of clinical research protocols under the direction of Physician Investigators and/or Clinical Research Specialists and Coordinators including the evaluation of new clinical research protocols and submission of initial regulatory documentation and preparation of IRB applications. Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. **MINIMUM QUALIFICATION(S):** + Associates Degree plus three (3) years of experience in a healthcare or research setting required, or five (5) years of experience in a healthcare or research setting required, or Bachelor's degree plus one (1) year or experience. + Active certification and/or appropriate licensure in the respective field of expertise required (i.e. EMT, LPN, MLT), if applicable. + Must have either a SoCRA or ACRP certification. 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. **For more information:** About Us | Careers | Penn State Health (************************************************************** **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. **For a full list with more detailed information:** ****************************************************************** **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 description is a general outline of duties performed and is not to be misconstrued as encompassing all duties performed within the position. All individuals (including current employees) selected for a position will undergo a background check appropriate for the position's responsibilities._ _Penn State Health is fundamentally committed to the diversity of our faculty and staff. We believe diversity is unapologetically expressing itself through every person's perspectives and lived experiences. We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information. If you are unable to use our online application process due to an impairment or disability, please call ************ between the hours of 7:00 AM and 5:00 PM, Eastern Standard Time, Monday through Friday, email *********************************** or download our Accommodation Instructions for Job Applicants PDF for more detailed steps for assistance._ **Union:** Non Bargained **Position** Associate Clinical Research II - VARIED SHIFTS - Emergency Medicine **Location** US:PA: Hershey | Allied Health | Temporary **Req ID** 51301

div id="job-details" /u/strong/p pUMass Amherst, the Commonwealth's flagship campus, is a nationally ranked public research university offering a full range of undergraduate, graduate, and professional degrees. The University sits on nearly 1,450-acres in the scenic Pioneer Valley of Western Massachusetts and offers a rich cultural environment in a bucolic setting close to major urban centers. In addition, the University is part of the Five Colleges (including Amherst College, Hampshire College, Mount Holyoke College, and Smith College), which adds to the intellectual energy of the region./p p /p pstrongu Job Summary/u/strong/p pThe Community-Engaged Research Coordinator works with the PI's in the Department of Psychological and Brain Sciences (PBS) conducting community-engaged research aimed at eliminating health inequities and addressing the harmful effects of violence and discrimination on marginalized communities. This role is to support this research as well as serve as liaison between the community, the researching staff, and local collaborators in Holyoke, MA amp; Springfield, MA. /p p /p pstrongu Essential Functions/u/strong/p ul type="disc" li Works with Department of Psychological and Brain Sciences (PBS) PI's conducting community-engaged research to help sustain reciprocal community research partnerships./li li Builds, strengthens and sustains relationships between PBS PIs and community organizations to support the mission of community-engaged research. This specifically includes working with community stakeholders to develop strategies for answering community questions as well as advancing community priorities related to health and well-being./li li Supports training of undergraduate research assistant(s) and volunteers(s) working on community-engaged research projects as needed./li li Represents community-engaged PI's research group(s) at campus, statewide and community events relevant to their research missions./li li Creates a community advisory committee comprised of adult and youth perspectives. Ensures regular communication and follow-up and completion of assigned project tasks./li li Coordinates meetings (and other events), including reserving meeting space, drafting agendas, confirming attendance, taking detailed minutes, and arranging refreshments as appropriate./li li Researches and maintains an updated list of local community events. Attends relevant events as necessary and coordinates the staffing at community events./li li Assists with dissemination of research findings to community partners and participating families (e.g., newsletters, community presentations and reports), in English and Spanish./li li Works effectively with diverse communities, researchers, faculty, administrators, and others./li /ul p /p pstrongu Other Functions/u/strong/p ul type="disc" li Works collaboratively and effectively to promote teamwork, diversity, equality, and inclusiveness. /li li Works in partnership with colleagues within the CNS community and across the campus to support Dean's strategic priorities./li li Demonstrates strong understanding of the principles and practices of community-based research, broad and deep familiarity with community-based organizations, and strong organizational skills./li li Performs other duties as assigned in support of the mission and goals of the College of Natural Sciences./li /ul p /p pstrongu Minimum Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure)/u/strong/p ul li Associate's degree and six (6) years of relevant work experience in forming and maintaining community-based research and partnerships OR Bachelor's degree and four (4) years of relevant work experience in forming and maintaining community-based research and partnerships OR Master's degree and two (2) years of experience in forming and maintaining community-based research partnerships. /li li Bilingual fluency in English and Spanish, speaking, reading, and writing./li li Valid driver's license./li li Previous experience with Microsoft Office suite./li li Excellent written and oral communication skills./li /ul p /p pstrongu Preferred Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure)/u/strong/p ul li Master's degree in Psychology, Public Health, Social Work, or related fields./li li Experience in forming and maintaining community-based research partnerships can be through Master's program./li /ul p /p pstrongu Physical Demands/Working Conditions/u/strong/p ul li Typical office environment./li /ul p /p pstrongspan style="text-decoration: underline"Additional Details/span/strong/p ul li This position is located at both the UMass Amherst campus and the UMass Center - Springfield and will require travel between locations./li /ul p /p pstrongu Work Schedule/u/strong/p ul li Monday - Friday, 8:30 am - 5:00 pm with flexibility to accommodate night and weekend events./li li Some nights and weekends are required./li /ul pem /em/p pstrongu Salary Information/u/strong/p pLevel 26/p pa href="******************************************************** rel="noopener noreferrer" target="_blank" title="PSU Hiring Ranges"PSU Hiring Ranges/a/p p /p pstrongu Special Instructions to Applicants/u/strong/p pAlong with the application, please submit a resume and cover letter which includes a Contributions to Inclusive Excellence Statement (see below). References will be checked at the finalist stage. Please be prepared to provide contact information for three (3) professional references. Applications will be reviewed on a continuous basis until the position is filled. Early submissions are encouraged./p pAt UMass Amherst and in CNS, we strive to be a community where every individual feels a sense of belonging, where every individual is included, and where every individual is valued. You can find these values and goals here: a href="******************************************************************************************************** For this reason, we request that all applicants submit a Contributions to Inclusive Excellence Statement that addresses how you see yourself contributing to our community and campus climate and/or our shared goals of building a more inclusive, equitable, and diverse community./p p /p pem UMass Amherst is committed to a policy of equal opportunity without regard to race, color, religion, caste, creed, sex, age, marital status, national origin, disability, political belief or affiliation, pregnancy and pregnancy-related condition(s), veteran status, sexual orientation, gender identity and expression, genetic information, natural and protective hairstyle and any other class of individuals protected from discrimination in employment, admission to and participation in academic programs, activities, and services, and the selection of vendors who provide services or products to the University. To fulfill that policy, UMass Amherst is further committed to a program of affirmative action to eliminate or mitigate artificial barriers and to increase opportunities for the recruitment and advancement of qualified minorities, women, persons with disabilities, and covered veterans. It is the policy of UMass Amherst to comply with the applicable federal and state statutes, rules, and regulations concerning equal opportunity and affirmative action./em/p /div

Coordination of clinical research studies. Performance of regulatory tasks including IRB and sponsor/CRO regulatory correspondence. Communication with IRBs, sponsors, and protocol-related Upstate Departments. Pre-screen, Screen, and enroll research participants in outpatient and inpatient clinical trials. Process and ship lab samples. Schedule and conduct follow up research appointments for clinical trial participants. Data collection and entry into paper and electronic databases. Maintenance of clinical research supply inventory. Processing clinical trial billing and payments. Administration of study questionnaires and assessments. Occasional travel. Minimum Qualifications: Bachelor's degree and 2-year's related experience or equivalent combination of education and experience. Preferred Qualifications: Prior experience with clinical research protocols and/or experience with coordinating clinical trials. ACRP and/or SOCRA certification. Work Days: Mon- Fri 8-4:30 with occasional after hours Message to Applicants: Salary Range-$58,000-$60,000 Recruitment Office: Human Resources

Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team. Responsibilities Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols. Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team. Ensure compliance with the Good Clinical Practice guidelines in clinical research. Monitor study patients for adverse events in collaboration with clinical team and report as required. Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements. Qualifications Education requirement: BS Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments. Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office. Under general supervision, the Clinical Research Associate - IVI is responsible for performing series of qualitative and quantitative analyses of patient intravascular image (IVI)s. ESSENTIAL DUTIES AND RESPONSIBILITIES Acts as a point person for assigned trials Responsible for setting up new trial documentation, Case Report Forms, Technician Worksheets; uses templates and revises for assigned client Becomes familiar with protocols and sub study for assigned client. Creates or revises, as needed, for review by Medical Director and Assistant Director, IVI Creates initial database/excel spreadsheet to track work Acquires images, logs work that is being completed Archives, digitizes, controls the quality, and performs measurements and image interpretation of intravascular ultrasound (IVUS), Virtual HistologyTM (VH)-IVUS, optical coherence tomography (OCT), near infrared spectroscopy (NIRS), and physiology recordings received in the core lab, related to ongoing contracted studies Follows training IVUS, VH-IVUS, OCT, NIRS, physiology and any other intravascular imaging modalities to maintain consistency of readings Responsible for analysis of assigned trials Receives and answers queries; contacts site coordinators or PIs and works with the sponsor to resolve issues May be responsible for data management activities Responsible for additional research, presentation, and academic activities as assigned Initially works in catheterization laboratory once a week or at department director's discretion to understand how to set up the ultrasound scanner, perform on-line measurements and understand basic coronary anatomy and principle of percutaneous interventions Additional duties as assigned QUALIFICATIONS B.A. or B.S. degree in Biomedical Engineering or Life Sciences 0 - 2 years working experience in a medical, academic or pharmaceutical environment Knowledge of medical terminology and morphology of the heart preferred Must be proficient in Microsoft Excel, Word, and Outlook Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment Ability to verbally communicate effectively with staff, physicians, nurses, managers, trial sponsors and colleagues. Ability to communicate effectively when reading and writing e-mail, letters, Manual of Operations, Case Report Forms and other reports or company documents Ability to analyze information and solve problems relating to intravascular images BENEFITS Choice of health plans include medical, Dental, and vision coverage Company-paid short-term and long-term disability and life insurance Health and dependent care flexible spending accounts Pre-tax travel expenses through TransitChek program 401(k) plan Generous paid time off (PTO) Ten paid holidays each year COMPENSATION The hiring range for this position is $52,000 - $58,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience. CONTACT INFORMATION To be considered for this opportunity, please submit your resume. Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day *********** CRF is an equal opportunity employer.

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

The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The CRC will work collaboratively with the principal investigator (PI), the Sr. Clinical Research Coordinator (SCRC), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. * Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. * Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). * Assist in the process of maintaining and updating each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. * Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312), with assistance as applicable. * Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product (IP), IP side effects and safety, communication with study staff and research rights. * Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. * Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. * Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI, with assistance as needed. * Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance with the study protocol by our clinical partners, with assistance as needed. * Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. * Aid in the coordination of long-term storage of research records in accordance with contractual requirements, with direction from the Director of Clinical Research. * Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits or regulatory authority inspections. * Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports, with assistance as needed. * Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. * Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. * Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. * Adheres to the USRC Research quality assurance program guidelines. * Travel to Investigator Meetings or similar research related meetings is required. * Travel may be required between dialysis facilities or nephrology practices within the community. * Develops a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. * May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. * Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. * Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. * Participate in staff meetings as required. * Regular and reliable attendance is required for the job. * Actively promotes GUEST customer service standards; develops effective relationships at all levels of the organization. * Participates in team concepts and promote a team effort; performs duties in accordance with company policies and procedures. * Regular and reliable attendance is required for the job.

Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs. The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists. Job Responsibilities * Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy * Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA) * The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience * May co-lead study team meetings in partnership with Clinical Operations study lead * Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting. * Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs) * Provides strategic clinical science support for assigned studies and programs * Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required * May author and/or review clinical narratives in conjunction with pharmacovigilance * in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming * Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians * In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts) * As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists * Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff. * As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects * Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment Core Competencies * Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally * Outstanding written communication skills * Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points * Comfortable working in fast paced entrepreneurial environment * Ability to travel up to 20% Education and Experience * Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred) * Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials * experience in CAR T-cell therapy is preferred * Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols * Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research Physical Requirements * In office 4 days per week, required * Sedentary, desk position Salary Range * $175,000-225,000 (final salary is dependent on candidate's experience and credentials)

The Clinical Center Associate will schedule appointments using the following systems: scheduling.com, RIS and EMR. The Clinical Center Associate will check in patients, answer phones, file paperwork, download orders into EMR, and ensure insurance authorizations are in place.

This position provides clinical supervision, development, coordination and oversight of substance use and mental health treatment. The Clinical Coordinator oversees program planning, and implementation of clinical services and evidence-based practices. Responsibilities Provides clinical leadership, direction, education and training within the organization's residential treatment programs. Establishes and coordinates addictions evidence-based practices to meet the ongoing and changing treatment and support needs of the programs' residents. Provides substance use disorder screening, intake, and orientation as needed. Provides treatment planning, individual and group counseling, family counseling, and psycho-social education as needed, as well as training for clinical staff. Reviews and final approves clinical documentation. Participates in the development, coordination and implementation of organizational policies and procedures. Requirements Must possess a valid New York State driver's license. Advanced level CASAC or other QHP required with a Bachelor's degree in a social sciences, mental health or human relations field and a minimum of three years' full-time experience in the areas of administration, program development and clinical supervision of substance abuse and mental health programs. Or Master's or Advanced level CASAC or other QHP required with a Master's degree in a social sciences, mental health or human relations field and at least three years' full-time experience in the areas of administration, program development and clinical supervision of substance abuse and mental health programs. Salary Description $64,000/Year