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Clinical research associate jobs in Allentown, PA - 21 jobs

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Clinical Research Associate
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Clinical Research Scientist
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  • ONCOLOGY RESEARCH NURSE NAV I PRN

    Cooper University Health Care 4.6company rating

    Clinical research associate job in Ancient Oaks, PA

    About us At Cooper University Health Care , our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees to provide competitive rates and compensation programs. Cooper offers full and part-time employees a comprehensive benefits program, including health, dental, vision, life, disability, and retirement. We also provide attractive working conditions and opportunities for career growth through professional development. Discover why Cooper University Health Care is the employer of choice in South Jersey. Short Description Oncology and Research are specialized and require unique skill sets. Realigning our MD Anderson Research Department at Cooper with the MD Anderson Cancer Center at Houston's recommendation, allows research growth in both the structure and the types of studies we are able to offer our clients advanced care. The role of the Research Nurse Navigator provides advanced clinical management of research protocols. Research: 1.1 Works with research team to identify clinical trials that would be beneficial to the patient population. 1.2 Works with other nurse navigators to facilitate and assess possible patients for clinical trials, referring possible eligible patients to Research Department. Reviews physician schedules and patient charts to pre-screen inclusion criteria 1.3 Promotes research-based therapies/education to patients. 1.4 Works with clinical research coordinators to develop operational flow plans for each active research protocol New Patient Support & Education: 2.1 Educates, supports, and assists patients and their families, serving as a link to their doctors and supportive services before, during, and after their participation in a research study. This role is key in the implementation of multidisciplinary care throughout participation in a research protocol. 2.2 Facilitates and implements multidisciplinary cancer care for new research patients within the Cooper Cancer Institute. Functions across all disease sites and, therefore, is a vital resource for information and education related to all cancer research protocols. 2.3 Serves as liaison between new patients, physicians, and diagnostic services in order to expedite the start of participation in a research protocol. Explains role of nurse navigator to patient and family, triages/forwards questions to the appropriate disciplines 2.4 Understands the demands and experiences of cancer, the disease process/treatment and anticipates patient and family needs. Identifies areas in which the patient/family lack knowledge, then provides supportive information/teaching, incorporating the patient's cultural/spiritual beliefs. 2.5 Facilitates patient participation and control in clinical decision-making while providing emotional and informational support to the patient and family. 2.6 Completes all related documentation in a timely manner; provides communication throughout the oncology research team on an on-going basis. 2.7 Utilizes available data bases and other files in a manner that is understandable and accessible to other members of the team. New Patient Support & Education: 2.1 Educates, supports, and assists patients and their families, serving as a link to their doctors and supportive services before, during, and after their participation in a research study. This role is key in the implementation of multidisciplinary care throughout participation in a research protocol. 2.2 Facilitates and implements multidisciplinary cancer care for new research patients within the Cooper Cancer Institute. Functions across all disease sites and, therefore, is a vital resource for information and education related to all cancer research protocols. 2.3 Serves as liaison between new patients, physicians, and diagnostic services in order to expedite the start of participation in a research protocol. Explains role of nurse navigator to patient and family, triages/forwards questions to the appropriate disciplines 2.4 Understands the demands and experiences of cancer, the disease process/treatment and anticipates patient and family needs. Identifies areas in which the patient/family lack knowledge, then provides supportive information/teaching, incorporating the patient's cultural/spiritual beliefs. 2.5 Facilitates patient participation and control in clinical decision-making while providing emotional and informational support to the patient and family. 2.6 Completes all related documentation in a timely manner; provides communication throughout the oncology research team on an on-going basis. 2.7 Utilizes available data bases and other files in a manner that is understandable and accessible to other members of the team. Program Development: 3.1 Implements Research Physician outreach by assisting to identify areas of outreach need, overseeing physician outreach plans, and analyzing programmatic patient referrals and growth. 3.2 Works with Events Coordinator and program physicians in the planning and implementation of Research Community Education Programs. Multidisciplinary Tumor Board : 4.1 Attends and participates in Disease-Specific Tumor Boards. 4.2 Follows up and oversees if research plan agreed upon at tumor board is relayed to patient and necessary action taken. Also relays the agreed upon research follow up plan in writing to the multidisciplinary and clinical research teams. 4.3 Participates in multidisciplinary rounds and conferences. Helps to coordinate and assure all necessary data is available for multidisciplinary cancer team conference. Education: 5.1 Works with all CCI disciplines to develop, implement, participate and evaluate oncology research programs for patients, healthcare professionals and the community. Acts as liaison with outside research agencies 5.2 Develops educational resources for cancer patients and families interested in clinical research. 5.3 Provides education within the Cooper network and outside the institution as needed. 5.4 Provides educational programs and lectures for oncology fellows, surgical residents, medical students, and nurses. 5.5 Assists with onboarding and training of new research staff and other CCI faculty. Other: 6.1 Complies with all system and departmental policies and procedures; i.e., completes all related documentation. 6.2 Attends annual mandatory in-services. 6.3 Works efficiently, is flexible and sets priorities. 6.4 Maintains active and current professional credentials. 6.5 Back-up other research staff during vacations, etc. when qualified by education and credentials. 6.6 Performs other duties and functions necessary for the maintenance of efficient, economic and quality operation of the department and system. 6.7 Performs all related duties or special projects as assigned/required. 6.8 Is a participating member of the Research review Committee 6.9 Acts as a liaison/instructor for research staff for utilization of EPIC Experience Required 0-2 Years Required Minimum of 2 years Nursing experience required with oncology experience preferred. Minimum of 2 years research experience preferred Program Development experience preferred Education Requirements Bachelor's degree in nursing
    $50k-75k yearly est. 2d ago
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  • Lead Clinical Research Associate

    Global Channel Management

    Clinical research associate job in Raritan, NJ

    Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Lead Clinical Research Associate needs: BS/BA, MS is desirable 5+ years of site management of which a minimum of 2 years field monitoring experience Knowledge of applicable standards and regulations for clinical trial Experience in Cardiovascular Therapeutic area IVD Stud Experience Medidata RAVE system Lead Clinical Research Associate duties: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: Implementation of enrollment and recruitment strategies Assistance in vendors' selection processes • Additional Information $45/hr 12 months
    $45 hourly 60d+ ago
  • Lead Clinical Research Associate

    Integrated Resources 4.5company rating

    Clinical research associate job in Raritan, NJ

    Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Lead Clinical Research Associate Location: Raritan, NJ 08869 Responsibilities: LEAD CLINICAL RESEARCH ASSOCIATE: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: • Implementation of enrollment and recruitment strategies • Assistance in vendors' selection processes • Development, execution, management and compliance assurance of the Monitoring Plan • Review and approve trip reports, track scheduling, report submission metrics, site deviations and action items • Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. • Development of training materials and study tools for site and CRA use • Assistance in formation of the Adjudication Committee including oversight of documentation collection and filing into the Trial Master File Qualifications Qualifications: LEAD CLINICAL RESEARCH ASSOCIATE: • BS/BA, MS is desirable • 5+ years of site management of which a minimum of 2 years field monitoring experience • Knowledge of applicable standards and regulations for clinical trial • Proven oral and written communication skills • Proven planning skills; ability to create and track detailed project plans • Proven interpersonal, leadership, organizational and effective time management skills • Microsoft Office proficiency • Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion • Experience in Cardiovascular Therapeutic area • IVD Stud Experience • Medidata RAVE system Additional Information Kind Regards, Sabanaaz Shaikh Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
    $50k-75k yearly est. 60d+ ago
  • Distinguished Scientist, Clinical Research, Thoracic Malignancies

    Merck 4.6company rating

    Clinical research associate job in Upper Gwynedd, PA

    Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology. The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. Specifically, the Executive Director, PDT Lead may be responsible for: + Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications. + Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations. + Planning clinical trials (design, operational plans, settings) based on these clinical development strategies + Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents + Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications + Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities. + Provide support for other therapeutic areas regarding clinical issues related to oncology compounds. The Executive Director, PDT Lead may: + Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects. + Supervise the activities of entire Clinical Teams in the execution of clinical studies. + Will report to and work collaboratively with the Section Head to promote the development strategy of the company on the indication of interest. + Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Executive Director is responsible for maintaining a strong scientific fund of knowledge by: + Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies + Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs + Establishing communications with prominent clinical investigators in their field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs + Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility. To accomplish these goals, the Executive Director, PDT Lead may: + Author detailed development documents, presentations, budgets, and position papers for internal and external audiences + Facilitating collaborations with external researchers around the world + Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. **Education:** M.D or M.D./Ph.D. **Required Experience and Skills:** + Must have experience in industry in the field of Thoracic Oncology + Minimum of 3 years of clinical medicine experience + Minimum of 5 years of industry experience in drug development + Demonstrated record of scientific scholarship and achievement + A proven track record in clinical medicine and background in biomedical research is essential + Strong interpersonal skills, as well as the ability to function in a team environment, are essential. **Preferred Experience and Skills:** + Board Certified or Eligible in Oncology (and/or Hematology) + Prior specific experience in clinical research and prior publication **Required Skills:** Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trial Planning, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Drug Development, Ethical Standards, Medical Research, Oncology, Pulmonology, Regulatory Requirements, Research Methodologies, Scientific Consulting, Scientific Leadership, Scientific Research, Strategic Leadership **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $310,900.00 - $489,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 01/30/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381175
    $80k-125k yearly est. 3d ago
  • Oncology Early Stage Clinical Scientist (Director, Non-MD)

    Pfizer 4.5company rating

    Clinical research associate job in Collegeville, PA

    You will lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). You will lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. You will also work with other functional disciples to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as need within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine). POSITION RESPONSIBILITIES Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s) Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results Support execution for all FIH programs through proof-of concept Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends; review and query data; present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics. Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors Support and assist in the development of publications, abstracts, and presentations May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials. Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of early signs of efficacy [ESoE] and POC trials). Lead the preparation of clinical protocols and support other critical documents including clinical development plans, INDs, annual reports, clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships and mutual trust among teams and therapeutic areas. Coordinate with other clinical research activities within Oncology Research Development (ORD) and the broader Worldwide Research and Development (WRD) organization. Develop effective collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision medicine, and development operations. Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated into relevant programs for early efficacy signs and POC, as well as patient stratification. Establish and support relationships with external experts, consultants, key opinion leaders, regulators, and investigator networks to integrate the latest clinical thinking and guidelines into development plans and study designs, as well as manage study recruitment, analysis, interpretation, and presentation of results. Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas, including key clinical development issues. Perform other duties as assigned related to clinical programs. Support functional area priorities and contribute to or lead departmental initiatives as requested. MINIMUM QUALIFICATIONS / KEY SKILLS Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies Experience in or strong understanding of Oncology Drug Development especially in Early Development Strong knowledge of clinical procedures, ICH guidelines,GCP and familiarity with FDA, EMA, and global regulations. Strong scientific writing skills and communication skills (written and verbal) Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis. Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations. Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance. Experience building consensus and driving change across all levels of the organization including senior management. Data listing review experience Critical thinker, with experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform PREFERRED QUALIFICATION Experience leading a team This position does not require you to be medical qualified Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Perform complex data analysis NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS 5-10% Travel Work Location Assignment: Hybrid The annual base salary for this position ranges from $176,600.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical
    $99k-124k yearly est. Auto-Apply 4d ago
  • Clinical Trials-Project Coordinator

    Mindlance 4.6company rating

    Clinical research associate job in Collegeville, PA

    Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description • This role is to provide comprehensive project coordination support for reducing the risk of phishing by supporting Info Protect Culture Change Behavioral Research Project • Clinical experience is helpful but not mandatory • Provide operational support and project administration for the Info Protect Culture Change Behavioral Research Project. The role entails coordinating clinical project development and implementation, project monitoring and control, risk management, and project governance. Efforts must adhere to principles of transparency across the programs and enable comparability with other efforts. Incumbent will serve as an operational 'single point of contact'; Collaborate with internal and external partners and vendors; Develop and implement project activities as assigned by the project manager; Track study budget spend and report monthly; Review and reconcile invoices for payment approval; and create and maintain project documentation including project plans, meeting minutes and agenda, project risk and decision logs, and other documents needed for project execution. Qualifications • Experience running clinical trials or University studies not required but recommended. • Project Admin/Coordinator - Level of knowledge/expertise: Extensive capability and expert understanding Job Profile: project admin/coordinator Provide administrative project planning support to Programme/Project Manager as required and provide plans converted into various formats Convert the output of the PM meeting into a monthly report and maintain the ISAC and FPAC project tracking tools Provide support to the PMO as requested. • The Information Protection programme at multi-year global programme to protect information. Within the programme, there is an Information Protection Culture work stream with the goal to fundamentally drive worldwide employee culture change for protecting information through education and awareness.
    $50k-71k yearly est. 24m ago
  • Scientist - Clinical Biomarkers (Translational Sciences)

    Insight Global

    Clinical research associate job in Lower Gwynedd, PA

    Join our Translational Sciences team within Gastroenterology to support biomarker strategy and assay development for clinical trials. This role is ideal for a hands-on bench scientist passionate about molecular and cellular biology and eager to contribute to defining the mechanism of action for innovative therapies. ________________________________________ Key Responsibilities - Develop and qualify clinical assays for incorporation into clinical trials. - Perform bench work including: o Flow cytometry, ELISA, qPCR, and immunohistochemistry. o RNA isolation, protein extraction, and cell-based assays. o Isolation of immune cells from biopsies or blood. - Work with ex vivo biopsy samples, patient samples, and cell lines (BSL-II). - Execute novel assay development and maintain accurate documentation in Electronic Lab Notebook (ELN). - Conduct first-pass data analysis and summarize findings. - Collaborate with translational science leads and project teams to ensure alignment with clinical objectives. - Communicate effectively with internal stakeholders and external vendors. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to ********************.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: **************************************************** Skills and Requirements Qualifications - Education: Bachelor's or Master's degree in Biology, Immunology, Molecular Biology, or related field. - Experience: o 1-2 years of real-world bench experience (industry or academic). o Hands-on experience with immunoassays and molecular techniques. o Familiarity with human sample handling under BSL-II conditions. - Skills: o Strong organizational and documentation skills. o Ability to analyze and interpret experimental data. o Excellent verbal communication and team collaboration. Preferred Background - CRO experience. - Immunology expertise (oncology or neuroscience acceptable but less preferred). - Exposure to biomarker analysis and clinical trial workflows.
    $110k-141k yearly est. 60d+ ago
  • Clinical Study Manager

    Psg 4.2company rating

    Clinical research associate job in Collegeville, PA

    At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies. As specialists in recognising talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for. Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives. Job Description This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis. The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed. Qualifications pTMF Inspection Readiness activities Clinical Study Knowledge Experience: 3-5 years Education: Bachelors Degree Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT ************ ASAP! I want to know more about your preferences. If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!
    $50k-78k yearly est. 26m ago
  • Clinical Research_Medidate Rave exp_Raritan NJ_w2 only

    360 It Professionals 3.6company rating

    Clinical research associate job in Raritan, NJ

    360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description We are looking to fill a position for Clinical research Associate in Raritan NJ. Qualifications · 5+ years of site management of which a minimum of 2 years field monitoring experience · Knowledge of applicable standards and regulations for clinical trial • Proven oral and written communication skills • Proven planning skills; ability to create and track detailed project plans · Proven interpersonal, leadership, organizational and effective time management skills · Microsoft Office proficiency · Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion · Experience in Cardiovascular Therapeutic area · IVD Stud Experience · Medidata RAVE system Additional Information Webcam Interview is acceptable.
    $51k-75k yearly est. 60d+ ago
  • Clinical Project, Feasibility Analytics Manager

    Iqvia 4.7company rating

    Clinical research associate job in Durham, PA

    This Clinical Project Manager/Feasibility role plays a critical role in clinical trial planning and delivery by leading feasibility activities across the continuum-from program/protocol feasibility through country and site selection. This position combines strategic leadership, operational excellence, and cross-functional collaboration to ensure high-quality feasibility outputs that inform study planning and accelerate trial start-up. Key Responsibilities Ensure all services adhere to policies, local regulatory requirements, and ICH-GCP guidelines. Collaborate with Global Program Leads (GPLs), Global Trial Leads (GTLs), and study teams to execute feasibility-related objectives. Perform feasibility activities including: Program/protocol feasibility Country and site selection Data compilation and analytics development Creation of presentation-ready slides for study teams Develop integrated feasibility plans aligned with study objectives and timelines. Partner with analytics teams, study team members, and country contacts to deliver feasibility outputs on time and with high quality. Support survey distribution, follow-up, and response analysis. Assist with site list development, management, and communication. Generate content for newsletters and other communications to ensure successful execution of feasibility processes. Advanced Responsibilities: Act as a Global Feasibility Lead within a therapeutic area, managing a book of work autonomously. Lead end-to-end feasibility processes for assigned studies. Project Leadership Integration: Collaborate with cross-functional teams to identify risks and implement mitigation strategies. Monitor progress against feasibility timelines and proactively communicate updates to stakeholders. Contribute to lessons learned and best practices for continuous improvement. Support staff development and mentor less experienced team members on feasibility processes. Interfaces Other: Global Feasibility TA Heads, Feasibility Insights Managers, Feasibility Data Sciences, Project Management Organization, Global Clinical Operations, EBIS, IT External: CRO feasibility teams, investigational sites, vendors focused on study placement, protocol design, and patient recruitment/retention Education & Experience Bachelor's degree required Minimum 3+ years of pharmaceutical industry experience in roles such as data procurement, business development, data strategy, or similar 3+ years as part of a clinical trial feasibility team at a pharma or CRO Direct feasibility experience preferred Advanced PowerPoint skills and intermediate Excel proficiency Strong organizational skills and ability to manage multiple projects Understanding of assigned therapeutic area Ability to analyze survey results and compile insights Excellent written and verbal communication skills, including compelling slide design Proven success working within a matrix organization to deliver high-quality outputs Extensive experience in feasibility analytics interpretation IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
    $93.1k-232.8k yearly Auto-Apply 60d+ ago
  • Program of Study Coordinator & Recruiter

    Lackawanna College 4.1company rating

    Clinical research associate job in Bethlehem, PA

    Job Description LACKAWANNA COLLEGE HAS BEEN VOTED ONE OF THE “BEST PLACES TO WORK IN PA” FOR 2014, 2015, 2016, 2017, 2019, 2020, 2023 and 2024! Lackawanna College is a private, accredited college serving the people of Northeastern Pennsylvania. Our main campus is located in downtown Scranton, and our footprint includes satellite centers in Covington Twp., Hawley, Hazleton, Sunbury, Towanda and Tunkhannock Our mission is to provide a quality education to all persons who seek to improve their lives and better the communities in which they live. We provide our students with a direct path to a bachelor's degree, associate degree, or one of many different professional certifications. Additionally, our Continuing Education department helps put the people of Northeastern Pennsylvania back to work with modern career skills. Lackawanna is also one of the most cost-efficient regional higher education institutions. If our mission inspires you, and you are willing to go the extra mile to help our students succeed, please feel free to apply for this or future employment opportunities for which you meet the minimum qualifications. Please know that only the candidates who meet the minimum qualifications can be considered, and only those selected for interviews will be contacted by a college representative. No phone calls, please. ESSENTIAL FUNCTIONS, PRIMARY RESPONSIBILITIES AND OBJECTIVES: The Program of Study Coordinator & Recruiter is responsible for supporting secondary to postsecondary transitions by implementing and managing articulated Programs of Study aligned with Pennsylvania's SOAR initiative. This role fosters strong partnerships with secondary schools, recruiting eligible students, and providing advising services to assist students in earning postsecondary credit and enrolling in Lackawanna College degree programs. Through curriculum alignment, data management, and stakeholder collaboration, the Coordinator ensures students are prepared to seamlessly continue their education toward a certificate or associate degree at Lackawanna College. This hybrid role requires some in-person attendance and up to 50% travel, inclusive of occasional overnight stays. The successful candidate must live within a commutable distance of Scranton or one of our Satellite Centers. *This is a full-time, 100% Perkins grant-funded position. ESSENTIAL FUNCTIONS: Coordinate and manage SOAR Programs of Study (POS) in accordance with Pennsylvania Department of Education (PDE) guidelines, ensuring proper implementation, alignment, and compliance with statewide articulation agreements. Collaborate with the Registrar's Office to ensure the accurate awarding and recording of SOAR credits, maintenance of academic records, and proper documentation of articulation agreements. Promote and recruit students into SOAR and POS programs by delivering presentations, attending career fairs, coordinating school visits, and providing outreach to students, parents, and high school staff. Provide advising services and support to students pursuing SOAR credits, including reviewing eligibility requirements, assisting with application processes, and explaining the benefits of earning postsecondary credit. Develop and maintain articulation agreements between secondary school districts, Career and Technical Centers (CTCs), and Lackawanna College to create seamless secondary-to-postsecondary pathways for Perkins approved majors. Serve as the primary liaison between secondary schools and Lackawanna College, fostering strong relationships with administrators, counselors, and CTE personnel to support dual enrollment, career pathways, and postsecondary transition for Perkins approved majors. Support the onboarding of new students entering Perkins approved majors, including assisting with freshman scheduling, coordinating transcript and task list evaluations, and ensuring students meet criteria for advanced credit based on program guidelines. Work with Academic Program Directors to align curricula, update marketing materials, and provide program-specific information to secondary schools and prospective students. Coordinate with Admissions and Enrollment teams across all Lackawanna College locations to ensure Perkins-eligible students are identified, tracked, and supported throughout the recruitment and enrollment process. Track and maintain data related to student participation, articulation agreements, enrollment trends, and credit attainment in college systems such as Jenzabar and JRM, ensuring accuracy and integrity for institutional reporting. Assist with PIMS and Perkins reporting by gathering required student and school-level data, coordinating submissions, and supporting the Local Application Administrator with accurate information. Monitor program outcomes such as retention, credential attainment, placement, and NOCTI performance, and use this data to recommend improvements or report on program impact. Serve as a member of Lackawanna College's Curriculum Committee. Participate in professional development opportunities related to CTE, SOAR, and dual enrollment by attending workshops, conferences, and training; maintain professional memberships as appropriate. Prepare and submit regular reports and activity logs (weekly/bi-weekly) summarizing activities, outreach, recruitment progress, school relationships, and updates on student credit evaluations. Support continuous improvement of the SOAR program through collaboration with internal and external stakeholders, curriculum updates, and identification of new opportunities for articulation or student engagement. Represent Lackawanna College and the Pre-College Department at public events, advisory councils, and external meetings to promote college access, career readiness, and post-secondary success. KEY COMPETANCIES: Good written and spoken communication skills. Good organizational skills. Excellent interpersonal skills. Ability to relate to diverse population groups. Proficient computer skills. Ability to prioritize and multitask responsibilities. Commitment to fulfillment of the College mission. EDUCATION: Bachelor's Degree required in related field. EXPERIENCE: 1 year recruiting experience preferred. Applications will only be accepted via online method by clicking the link below. Deadline for applications, February 13, 2026. No phone calls, please. ************************************************************************************************************************ Id=19000101_000001&job Id=560455&lang=en_US&source=CC2 In compliance with Title IX of the Education Amendments of 1972, Title VII of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, and all other applicable non-discrimination laws, Lackawanna College does not discriminate on the basis of race, color, religion, national or ethnic origin, sex, sexual orientation, age, disability, veteran's status, or genetic information in its educational programs and activities, admissions, and with regard to employment. Lackawanna College is an accredited, private, non-profit educational institution providing opportunities for career and personal development within selected associates degree, certificate and continuing education program.
    $36k-43k yearly est. 1d ago
  • Assistant/Associate Clinical Professor of SLPD Applied Research & Practice Coordinator

    Moravian University 4.2company rating

    Clinical research associate job in Bethlehem, PA

    CLASSIFICATION: Faculty 12-month, part-time DEPARTMENT: School of Rehabilitation Sciences, College of Health FLSA STATUS: Exempt SUPERVISION RECEIVED: Associate Dean of School of Rehabilitation Sciences; Program Director, Doctorate of Speech-Language Pathology SUPERVISION EXERCISED: N/A POSITION SUMMARY: Moravian University invites applications for a part-time, twelve-month clinical professor position (at the level of assistant or associate clinical professor) in the Speech-Language Pathology Doctorate (SLPD) program to serve as the Applied Research and Practice Coordinator. The primary responsibility of this role is to coordinate and support the successful completion of the applied research and practice projects that serve as the culminating project in the SLPD program. The faculty member will work collaboratively with students, mentors, and the program director to foster scholarly inquiry and translational application within the profession of speech-language pathology. This includes the day-to-day operations of the applied research and practice process. Moravian University's SLPD program is remote with one intensive on-campus learning experience. Thus, there is opportunity for this position to be remote. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Facilitate mentor-student matches Ensure academic writing standards Sponsor the IRB process Provide individualized support to students related to the applied research and practice process Maintain ongoing communication with students regarding their projects Contribute to policy and program development Support students to align projects with program expectations Teach coursework in the area of expertise or related to the applied research and practice course Participate in departmental, college, and university service initiatives Review of applications will begin on December 15, 2025. All positions are subject to budget availability. QUALIFICATIONS: Earned doctorate required (SLPD, PhD, EdD) Minimum of 5 years of experience practicing as a speech-language pathologist Active State SLP license ASHA CCC Preferred Evidence of an established scholarly agenda preferred At least 3 years of experience teaching academic courses or mentoring students or professionals (e.g., supporting advocacy projects, theses, capstones, dissertations, student research projects, community outreach, workplace improvement projects, supervision of student clinicians or clinical fellows, etc.) Demonstrated excellence in academic writing and familiar with APA-7 guidelines TO APPLY: Qualified candidates should attach their (1) cover letter, (2) curriculum vita, (3)statement of teaching philosophy, (4) statement of mentorship philosophy, and (5) names and contact information for at least three (3) references to their online application by clicking “Apply Now”. Please attach documents as a PDF file. Review of the applications will begin December 15, 2025, and continue until the position is filled. Incomplete applications will not be considered.
    $45k-58k yearly est. Auto-Apply 54d ago
  • Clinical Coordinator, Emergency Department - Warren and Easton Campuses (Full-time, Evenings)

    St. Lukes University Health Network 4.7company rating

    Clinical research associate job in Phillipsburg, NJ

    St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Clinical Coordinator is responsible for planning, coordinating, directing and evaluating daily operations and guiding the unit-based team. JOB DUTIES AND RESPONSIBILITIES: Develops, evaluates and adjusts current and future staffing based upon patient care needs. Assigns responsibility for patient care with the unit-based team. Maintains departmental records for administrative and regulatory purposes. Facilitates staff education activities (i.e. orientation, competency, skill reviews, mandatory in-servicing). Provides input to annual performance reviews of assigned staff. Participates in hiring and counseling staff. Conducts customer service activities and handling of complaints - patients, families, staff or physician. Assists with management functions on unit. Manages daily operations within budget parameters. Performs in depth, systematic assessment of all assigned patients. Formulates collaborative plans of care and identifies expected patient outcomes. Implements, evaluates and documents patient care interventions and effectiveness in accordance with care plan. Organizes, coordinates and prioritizes patient care consistently utilizing available resources. Demonstrates competency in the assessment, range of treatment, knowledge of growth and development and communication appropriate to the age of the patient treated. Takes active role in unit-based performance improvement and committees, as appropriate. PHYSICAL AND SENSORY REQUIREMENTS: Sit up to 2 hours per day; 1 hour at a time. Stand for up to 8 hours per day; 4 hours at a time. Walk up to 6 hours per day; 10 minutes at a time. Consistently lift, carry and push objects up to 10 pounds. Frequently lift, carry and push objects up to 75 pounds. Transport patients weighing up to 250 lbs. via wheelchair, bed and/or stretcher with assistance when appropriate. Consistently pull up to 10 lbs. Frequently pull up to 250 lbs. with assistance when appropriate. Frequently stoop and bend, crouch, kneel and climb. Frequently reach above shoulder level. Occasional crawling. Must be able to perceive attributes of an object through touch. Frequently finger and handle objects. Occasionally firmly grasp, twist, turn objects with hands and fingers. Must be able to hear as it relates to normal conversation, and high and low frequencies. Must be able to see as it relates to general, near, far color, and peripheral vision, depth perception, and visual monotony (e.g. computer screen). EDUCATION: Registered Nurse with current license to practice in the State of New Jersey or Pennsylvania, depending on work location. TRAINING AND EXPERIENCE: Two to five years nursing experience in unit specialty. Evidence of successful completion of BLS. MINIMUM - MAXIMUM COMPENSATION PAY RANGE: $74,800.00 - $119,680.00 St Luke's University Health Network is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. We will meet minimum wage or minimum of the pay range (whichever is higher) based on state requirements. BENEFIT OFFERINGS: St. Lukes offers comprehensive health, dental, vision, short term and long term disability, life insurance, generous PTO, sick leave and professional development opportunities. Join us to experience a supportive workplace with a focus on your growth and well-being. Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!! St. Luke's University Health Network is an Equal Opportunity Employer.
    $74.8k-119.7k yearly Auto-Apply 60d+ ago
  • Lead Clinical Research Associate

    Global Channel Management

    Clinical research associate job in Raritan, NJ

    Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Lead Clinical Research Associate needs: BS/BA, MS is desirable 5+ years of site management of which a minimum of 2 years field monitoring experience Knowledge of applicable standards and regulations for clinical trial Experience in Cardiovascular Therapeutic area IVD Stud Experience Medidata RAVE system Lead Clinical Research Associate duties: Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations. The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL). Additional responsibilities include: Implementation of enrollment and recruitment strategies Assistance in vendors' selection processes • Additional Information $45/hr 12 months
    $45 hourly 23m ago
  • Clinical Scientist

    Integrated Resources 4.5company rating

    Clinical research associate job in Collegeville, PA

    A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description RESPONSIBILITIES: • The Supporting Clinician will provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program. • coordinating and leading the investigation process on all manufacturing and laboratory incidents related to all deviations including biomanufacturing process and equipment deviations and deviations for all analytical assays. • protocol and study training • Data review and interpretation • study and/or program scientific and integrity oversight • safety review and communication • regulatory document, study report and publication preparation and review • Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician • Support the preparation of other clinical documents as required • DATA REVIEW AND INTERPRETATION: o Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables o Responsible for review of patient level data across a study and coordinating with Lead Clinician for study level review as delegated o Study analysis and decision point preparation o Interprets data and is able to identify issues of moderate/difficult complexity o Conducts data review independently • STUDY MEDICAL OVERSIGHT: o Collaborates with the Lead Study Clinician(s) and COSTL to provide guidance during the execution of the study o Provide input into the monitoring plan • SAFETY: o Ensure timely communication of safety issues o Review and approval of subject narratives as delegated by the Lead Clinician • REGULATORY AND PUBLICATIONS: o Provide input, review and edit clinical study reports (CSR) o Provide full review of content and integrates information from literature and other sources as appropriate o Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan, IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses) o Audit responses as delegated by the Lead ClinicianCLINICAL PROGRAM IMPLEMENTATION: o Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues o Initiate and coordinate corrective action for major medical/safety/scientific study level issues o Along with Lead Study Clinician(s) and COSTL and with regard to medical/safety concerns, ensures study level issues are resolved o Collaborate with Lead Clinician and COSTL to arrive at major site level decisions based on input from the team o Coordinates with Lead Study Clinician(s) and COSTL to maintain study timelines o Along with the Lead Study Clinician(s) and COSTL and other study team members, participates in training of Study Management Staff and monitoring staff o In collaboration with the Lead Study Clinician(s) and COSTL and study team, ensures the clinical trial material requirements of the study are met o Ensure standard processes, tools, and procedures used consistently and globally o Participates in developing training strategy for study with the study team members Provide input into the preparation of study level training materials in collaboration with Lead Study Clinician(s) and COSTL and team members o Ensures appropriate filing of documentation in the trial master file Qualifications QUALIFICATIONS AND SKILLS NEEDED: • M.D., PhD, Pharm. D. Degree in science or health-related field preferred, will consider highly motivated and experienced MA or MS • 10+ years of pharmaceutical/CRO experience preferred TECHNICAL SKILLS: • Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field • Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents • Has independently authored clinical study documents • Has experience with participating in and informally leading an operational team • Applies knowledge of internal/external business challenges to facilitate process improvements • Has ability to proactively resolve issues and work independently with minimal supervision • Has working knowledge of statistics, data analysis, and data interpretation • Has exceptional written and oral communication and cross-functional collaborative skills • Is proficient in MS Word, Excel, and PowerPoint
    $115k-143k yearly est. 60d+ ago
  • Clinical Trials-Project Coordinator

    Mindlance 4.6company rating

    Clinical research associate job in Collegeville, PA

    Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description• This role is to provide comprehensive project coordination support for reducing the risk of phishing by supporting Info Protect Culture Change Behavioral Research Project • Clinical experience is helpful but not mandatory • Provide operational support and project administration for the Info Protect Culture Change Behavioral Research Project. The role entails coordinating clinical project development and implementation, project monitoring and control, risk management, and project governance. Efforts must adhere to principles of transparency across the programs and enable comparability with other efforts. Incumbent will serve as an operational 'single point of contact'; Collaborate with internal and external partners and vendors; Develop and implement project activities as assigned by the project manager; Track study budget spend and report monthly; Review and reconcile invoices for payment approval; and create and maintain project documentation including project plans, meeting minutes and agenda, project risk and decision logs, and other documents needed for project execution. Qualifications• Experience running clinical trials or University studies not required but recommended. • Project Admin/Coordinator - Level of knowledge/expertise: Extensive capability and expert understanding Job Profile: project admin/coordinator Provide administrative project planning support to Programme/Project Manager as required and provide plans converted into various formats Convert the output of the PM meeting into a monthly report and maintain the ISAC and FPAC project tracking tools Provide support to the PMO as requested. • The Information Protection programme at multi-year global programme to protect information. Within the programme, there is an Information Protection Culture work stream with the goal to fundamentally drive worldwide employee culture change for protecting information through education and awareness.
    $50k-71k yearly est. 60d+ ago
  • Clinical Research_Medidate Rave exp_Raritan NJ_w2 only

    360 It Professionals 3.6company rating

    Clinical research associate job in Raritan, NJ

    360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description We are looking to fill a position for Clinical research Associate in Raritan NJ. Qualifications · 5+ years of site management of which a minimum of 2 years field monitoring experience · Knowledge of applicable standards and regulations for clinical trial • Proven oral and written communication skills • Proven planning skills; ability to create and track detailed project plans · Proven interpersonal, leadership, organizational and effective time management skills · Microsoft Office proficiency · Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion · Experience in Cardiovascular Therapeutic area · IVD Stud Experience · Medidata RAVE system Additional Information Webcam Interview is acceptable.
    $51k-75k yearly est. 24m ago
  • Clinical Coordinator-Operating Room

    St. Lukes University Health Network 4.7company rating

    Clinical research associate job in Allentown, PA

    St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Clinical Coordinator is responsible for planning, coordinating, directing and evaluating daily operations and guiding the unit based team. JOB DUTIES AND RESPONSIBILITIES: Develops, evaluates and adjusts current and future staffing based upon patient care needs. Assigns responsibility for patient care with the unit-based team. Maintains departmental records for administrative and regulatory purposes. Facilitates staff education activities (i.e. orientation, competency, skill reviews, mandatory in-servicing). Provides input to annual performance reviews of assigned staff. Participates in hiring and counseling staff. Conducts customer service activities and handling of complaints - patients, families, staff or physician. Assists with management functions on unit. Manages daily operations within budget parameters. Performs in depth, systematic assessment of all assigned patients. Formulates collaborative plans of care and identifies expected patient outcomes. Implements, evaluates and documents patient care interventions and effectiveness in accordance with care plan. Organizes, coordinates and prioritizes patient care consistently utilizing available resources. Demonstrates competency in the assessment, range of treatment, knowledge of growth and development and communication appropriate to the age of the patient treated. Takes active role in unit-based performance improvement and committees, as appropriate. PHYSICAL AND SENSORY REQUIREMENTS: Sit up to 2 hours per day; 1 hour at a time. Stand for up to 8 hours per day; 4 hours at a time. Walk up to 6 hours per day; 10 minutes at a time. Consistently lift, carry and push objects up to 10 pounds. Frequently lift, carry and push objects up to 75 pounds. Transport patients weighing up to 250 lbs. via wheelchair, bed and/or stretcher with assistance when appropriate. Consistently pull up to 10 lbs. Frequently pull up to 250 lbs. with assistance when appropriate. Frequently stoop and bend, crouch, kneel and climb. Frequently reach above shoulder level. Occasional crawling. Must be able to perceive attributes of an object through touch. Frequently finger and handle objects. Occasionally firmly grasp, twist, turn objects with hands and fingers. Must be able to hear as it relates to normal conversation, and high and low frequencies. Must be able to see as it relates to general, near, far color, and peripheral vision, depth perception, and visual monotony (e.g. computer screen). EDUCATION: Registered Nurse with current license to practice in the State of New Jersey or Pennsylvania, depending on work location. TRAINING AND EXPERIENCE: Two to five years nursing experience in unit specialty. Evidence of successful completion of BLS. Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!! St. Luke's University Health Network is an Equal Opportunity Employer.
    $55k-73k yearly est. Auto-Apply 39d ago
  • Clinical Trials Manager

    Global Channel Management

    Clinical research associate job in Raritan, NJ

    Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Qualifications Bachelor Degree required, preferably in biological or medical sciences. Master's Degree or higher is desirable. Minimum of 8 years direct clinical research experience, of which a minimum of 4 years clinical research supervisory or management capacity with budgetary responsibility. Knowledge of applicable standards and regulations for clinical trial and laboratory conduct Proven oral and written communication skills Proven planning skills; ability to create and track detailed project plans Proven interpersonal, leadership and organizational skills & Effective time management Ability to work independently and within a cross-functional team environment to analyze and solve problems, and to make sound decisions Basic biostatistical knowledge Must be willing to periodically work with potentially biohazardous materials in an approved safe manner and to work in biohazardous environments Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates Preferred: 2 years IVD Monitoring experience Experience in Cardiac clinical studies Strong technical lab expertise with demonstrated ability in assay analysis and data interpretation Additional Information $44/hr 12 months
    $44 hourly 60d+ ago
  • Clinical Coordinator, Pelvic Health- Outpatient Rehab

    St. Lukes University Health Network 4.7company rating

    Clinical research associate job in Bethlehem, PA

    St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care. The Clinical Coordinator, Outpatient Rehab is responsible for coordinating the therapy services of their specialty by developing strategies and objectives, providing services, and assisting in directing staff. JOB DUTIES AND RESPONSIBILITIES: Functions as a Physical Therapist, Occupational Therapist or Speech Language Pathologist or Audiologist. Evaluates and treats patients. Assists Program Manager in developing and implementing department programs by means of interacting with clinical staff to support program growth. Interact and actively promote the practice with physicians concerning appropriate patient referrals, provision of services, new programs, patient status, etc. Review of monthly referral/marketing reports and quarterly reports to make recommendations on marketing efforts. Orient/teach new techniques, share clinical knowledge, plan CEU opportunities to improve patient care. Review clinical outcomes and satisfaction scores of clinicians. Collaborate with the Program Managers, Facility Directors, Area Managers, and Regional Directors to develop action plans to improve as needed. Schedule, mentor, facilitate educational opportunities for students, fellows, and residents. In conjunction with the Program Managers, Facility Directors, Area Managers and Regional Directors, helps to develop the budget for fiscally responsible management of the department. Recommend policies for management of the department. Other duties may be assigned PHYSICAL AND SENSORY REQUIREMENTS: Must be able to sit for up to ninety minutes at a time. Be able to tolerate standing for thirty to forty-five minutes consecutively. Must be able to use hands/fingers to manipulate dials on machines. Must have the ability to lift/move patients up to 200 lbs., push/pull patients weighing up to 200lbs. Must have the ability to occasionally stoop/bend, squat, crouch, kneel, and reach to above shoulder level. Must be capable of tactile sensation as it relates to feeling muscle spasms, textures, and skin temperature. Must have the ability to hear as it relates to normal conversation and ability to hear call bells. Must be capable of seeing as it relates to general vision, depth perception, and peripheral vision. EDUCATION: Master's Degree from an accredited physical therapy, occupational therapy, audiology, or speech language program required. Doctorate Degree from an accredited physical therapy, occupational therapy, audiology, or speech language program preferred. Current Basic Life Support certification. TRAINING AND EXPERIENCE: At least 2 years full time clinical experience treating specialized patient population. Please complete your application using your full legal name and current home address. Be sure to include employment history for the past seven (7) years, including your present employer. Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable. It is highly recommended that you create a profile at the conclusion of submitting your first application. Thank you for your interest in St. Luke's!! St. Luke's University Health Network is an Equal Opportunity Employer.
    $55k-73k yearly est. Auto-Apply 31d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Allentown, PA?

The average clinical research associate in Allentown, PA earns between $46,000 and $108,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Allentown, PA

$70,000
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