Clinical research associate jobs in Barnegat, NJ - 66 jobs
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ONCOLOGY RESEARCH NURSE NAV I PRN
Cooper University Health Care 4.6
Clinical research associate job in Mount Laurel, NJ
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 clinicalresearch 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 clinicalresearch 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 clinicalresearch. 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
$51k-75k yearly est. 2d ago
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Clinical Research Associate Trainer
Systimmune
Clinical research associate job in Princeton, NJ
Job DescriptionSystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
The CRA Trainer will play a critical role in developing and delivering global training programs for ClinicalResearchAssociates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinicalresearch experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials.
Responsibilities
Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education).
Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards.
Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance.
Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight.
Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability.
Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed.
Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions.
Stay current with regulatory updates and industry best practices to ensure training content remains relevant.
Support development of study-specific training for CRAs and site personnel.
Maintain documentation of all training activities for audit readiness.
Qualifications
Bachelor's degree in health sciences or related field.
Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise.
Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address.
Excellent verbal and written communication skills; strong presentation and facilitation abilities.
In-depth knowledge of ICH-GCP guidelines and clinical trial processes.
Critical thinking for troubleshooting monitoring challenges
Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO).
Strong organizational and time management skills; ability to manage multiple priorities.
Experience in developing training materials and delivering educational programs preferred.
Ability to travel as needed (up to 25%).
Compensation and Benefits:
The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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$120k-160k yearly 11d ago
Clinical Research Associate Trainer
Systimmune, Inc.
Clinical research associate job in Princeton, NJ
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
The CRA Trainer will play a critical role in developing and delivering global training programs for ClinicalResearchAssociates (CRAs) both Internal and functional service providers (FSPs) to ensure compliance with ICH-GCP guidelines, local regulations, and company SOPs. This position requires a highly organized, proactive individual with deep clinicalresearch experience and a passion for mentoring and education. The CRA Trainer will collaborate with Clinical Operations leadership to standardize best practices and enhance CRA performance across all phases of clinical trials.
Responsibilities
* Design, develop, and implement comprehensive CRA training programs (onboarding and ongoing education).
* Create training materials, including manuals, SOP guides, and learning modules aligned with regulatory and company standards.
* Conduct live and virtual training sessions on monitoring practices, site management, and protocol compliance.
* Mentor CRAs on effective site relationship management, patient recruitment strategies, and data quality oversight.
* Provide guidance on clinical trial systems (CTMS, EDC, eTMF, IRT, ePRO, etc.) and investigational product accountability.
* Assess CRA competency through evaluations, feedback sessions, performance metrics, co-monitoring and monitoring report review as needed.
* Collaborate with the Clinical Project Managers within Clinical Operations to identify training gaps and develop targeted solutions.
* Stay current with regulatory updates and industry best practices to ensure training content remains relevant.
* Support development of study-specific training for CRAs and site personnel.
* Maintain documentation of all training activities for audit readiness.
Qualifications
* Bachelor's degree in health sciences or related field.
* Experience as a line manager of CRAs and a minimum of 10 years of experience as a CRA, preferred strong oncology trial expertise.
* Proven ability to conduct and oversee monitoring visits (site evaluation, initiation, interim, close-out) as well as identify gaps with mitigation strategies to address.
* Excellent verbal and written communication skills; strong presentation and facilitation abilities.
* In-depth knowledge of ICH-GCP guidelines and clinical trial processes.
* Critical thinking for troubleshooting monitoring challenges
* Proficiency in Microsoft Office Suite and clinical trial systems (CTMS, EDC, eTMF, IRT and ePRO).
* Strong organizational and time management skills; ability to manage multiple priorities.
* Experience in developing training materials and delivering educational programs preferred.
* Ability to travel as needed (up to 25%).
Compensation and Benefits:
The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
$120k-160k yearly 11d ago
Clinical Research Associate
Summit Therapeutics Sub
Clinical research associate job in Princeton, NJ
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit s team is inspired to touch and help change lives through Summit s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The ClinicalResearchAssociate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial.
Role and Responsibilities:
Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
Initiates and builds solid professional relationships with clinical site staff
Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
Creation and development of study trackers
Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc.
Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
Following and implementing assigned study related plans, processes, agreements, and guidelines
Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
Reviews and approves essential document packages to enable timely site activations.
Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
Ensures the study is inspection ready contemporaneously
Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
Bachelor s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
A minimum of 3+ years of clinicalresearch experience in conducting clinical trials
Prior phase II or III experience required
A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Experience with clinical studies oncology and / or rare diseases a plus
Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
Tenacity to work in a fast-paced team environment
Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships
Ability to successfully engage and work collaboratively with global team members/colleagues
Ability to support building and delivery of patient enrolment strategies
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
Ability to review and assess clinical data
Possesses excellent planning, time management & coordination skills.
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Experience in working in a small organization a plus
Excellent written and oral communication skills
The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit s Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.
$97k-114k yearly Easy Apply 25d ago
Clinical Research Associate
Impulse Dynamics Germany GmbH 4.3
Clinical research associate job in Marlton, NJ
ClinicalResearchAssociate Marlton, NJ Hope is Here! Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM TM, which is delivered by the company's Optimizer Smart System. CCM is a first-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany.
The Clinical Department is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines. Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics. In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers.
How You'll Add Value
* Manage and organize all administrative aspects for assigned clinical trials, including creation and maintenance of site personnel contact information, mass mailings, study regulatory documents, and electronic or binder preparation for distribution.
* Assist the CTM with overseeing the monitoring visit scheduling and monitoring report review
* Prepare CST meeting minutes.
* Act as a resource for the clinical sites and research monitors for the trial.
* Assist with training of site staff who are working on the study.
* Collect regulatory documentation and ensure accuracy. Record the receipt of all key study documentation and contact site regarding missing records.
* Review various study-related tracking systems to determine and report the status of clinical trial documents.
* Collect outstanding documents by contacting the clinical trial sites or working with the field monitors.
* Send notifications to the clinical trial sites regarding their IRB renewal dates.
* Maintain and audit all study-related files in compliance with department standard operating procedures.
* Assist with the follow-up and resolution of noted observations on audit and monitoring reports.
* Work with the clinical trial sites to ensure all required testing is forwarded to and received by the Core Laboratories.
* Ensure consistent use of study tools and training materials and compliance with standard operating procedures and policies.
* Make all the arrangements for periodic meetings, such as Physician Adjudication Committees, Data Safety Monitoring Boards, and Monthly Webcast meetings, and assist the Clinical Trial Manager with the preparation of the meetings.
* Review and approve Site Qualification Reports for new clinical trial sites
* Train users on the EDC/case report forms and other systems that may be used (i.e., electronic regulatory Binders).
* Maintain the CTMS for site budgets and payments in accordance with the scheduled budget for each clinical trial site agreement. Ensure invoices are reviewed and approved on a timely basis and submitted to accounting for payment.
What You're Bringing with You
* 1-2 years of clinicalresearch experience with a bachelor's degree and/or
* 4 years of clinicalresearch experience with professional certification (CCRP, ACRP)
* Experience with communicating with hospital administrators, research nurses, and study coordinators.
* Working knowledge of FDA regulations, Good Clinical Practices (GCPs), and all applicable state, local, and federal regulatory requirements.
* Experience with IBM EDC, ClinPlus CTMS, Florence e-Binders, Egnyte, and/or other eRegulatory solutions.
* Medical device and/or heart failure clinical trials experience preferred.
* Bachelor's degree in life sciences or related field preferred or equivalent work experience.
Our commitment to you
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that's enjoyable, thorough, and fair. That's our way of inspiring the innovative brightest minds.
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around the diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
Annual Base Salary Range: $ 60,000 - $ 75,000
* Full Coverage Medical Benefits - Employee + family contribution is 100% covered by Impulse Dynamics.
* Paid Vacation, floating holidays, and sick time.
* Paid Holidays
* 401k Match (up to 6%)
* Annual bonus eligibility
Unless specifically indicated communicated otherwise in writing, all employees are "at-will" employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee's employment.
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.
$60k-75k yearly 7d ago
Research Coordinator
Regional Cancer Care Associates 4.2
Clinical research associate job in Freehold, NJ
Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management.
We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you!
Employment Type: Full Time
Location: Freehold, NJ
Compensation: $27.09 - $36.54 per hour
Compensation packages based on your unique skills, experience, and qualifications
As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being and professional growth of our employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Demonstrate understanding of the protocol elements and requirements.
Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial
Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality.
Screening, recruit, enroll prospective patients using EMR, EDC, CTMS
Create and maintain enrollment logs for each trial from beginning to end
Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial.
Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial.
Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance.
Enter all the data to EDC, and EMR within 24 hours of data collection.
Communicate and resolve all the data queries within 5-days
Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents
Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times.
Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP
Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements.
Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues.
Supports internal and external audits
Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements.
Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions.
Conduct clinical trial weekly and monthly meetings within the division.
Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings.
Track and submit clinical trial patient reimbursement.
Other duties as assigned.
Requirements
Minimum Job Qualifications:
Minimum 1 year of experience with oncology interventional clinical trials.
ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified ClinicalResearch Professional with one year of oncology trial experience.
High School diploma with four years of oncology clinical trial experience.
Computer literate with good interpersonal, writing, and verbal communication skills.
Previous regulatory affairs experience is a plus.
Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network.
Prior experience working with centrifuge and handling biofluid specimens is preferred.
Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure.
Working Conditions:
Traditional office environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.)
Large percent of time performing computer based work is required
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Salary Description $27.09 - $36.54
$27.1-36.5 hourly 60d+ ago
Associate Director, Clinical Research Scientist
Taiho Oncology 4.4
Clinical research associate job in Princeton, NJ
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.
Hybrid
Employee Value Proposition:
At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As an Associate Director, ClinicalResearch Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinicalresearch and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research.
Position Summary:
The Associate Director, ClinicalResearch Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed.
Performance Objectives:
Uses medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures.
At the asset level, assists the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages).
Works with the medical lead to prepare presentations (internal and external), abstracts, manuscripts.
Inputs into the of ICF/reviews ICF.
Works with data management on CRF design and completion guide.
Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan.
Reviews protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raises queries and coordinates with the medical lead.
Reviews safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations.
Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study.
Ensures TMF compliance for clinical development/medical study level TMF documents.
Answers specific site protocol questions as needed, after consultation with the medical lead.
Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead.
Escalates protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member.
Reviews the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead.
Education/Certification Requirements:
PhD, PharmD or other related Advanced Medical Scientific Degree.
Experience in oncology is a must.
Knowledge, Skills, and Abilities:
At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents.
Ability to critically review and interpret Clinical data.
Working knowledge of the drug development process in the USA and EU is required.
Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
The pay range for this position at commencement of employment is expected to be between $213,350 - $251,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-Hybrid
$75k-124k yearly est. 6d ago
Clinical Research Coordinator Sr.
Cenexel 4.3
Clinical research associate job in Marlton, NJ
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinicalresearch managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel ClinicalResearch also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Compensation: $35-$41/h depending on education, experience, and skillset.
Essential Responsibilities and Duties:
Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.
Organizes research information for clinical trials.
Observes subjects and assists with data analysis and reporting.
Oversees study protocol scheduling and collection of data.
Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
Manages, monitors, and reports research data to maintain quality and compliance.
Performs administrative and regulatory duties related to the study as appropriate.
Participates in other protocol development activities.
Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.
Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
Educates potential participants and caregivers on protocol specific details and expectations.
Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities.
Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness.
Trains, mentors, and/or manages Research Assistants and lower level ClinicalResearch Coordinators.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:
Must have proper experience and demonstrate mastery of ClinicalResearch Coordinator II position.
Bachelor's degree, preferred.
CCRC certification preferred.
5 years of experience in the medical field or Masters Degree, preferred.
Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
Strong leadership and mentorship skills.
Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
Works independently as well as functioning as part of a team.
Must be able to effectively communicate verbally and in writing.
Working Conditions
Indoor, Office environment.
Shift work, depending on location.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
Overnight travel may be required for training and/or investigative meetings.
CenExel ClinicalResearch is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
$35-41 hourly 19d ago
Clinical Research Assistant
Mid Atlantic Retina 3.9
Clinical research associate job in Cherry Hill, NJ
This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires.
Job Description
The primary responsibility of the Research Assistant is to assist the Research Unit in conducting clinical trials. The Research Assistant is responsible for collecting and processing clinical data and providing administrative support to the Research Team.
Essential Functions
* Assists the Research Coordinator with the conduction of clinical trials and patient flow.
* Accurately collects clinical data on research patients. Maintains and updates information in data base.
* Assists Coordinator with monitor preparation and follows up on any action items and query resolution.
* Assists in trial recruitment (chart reviews, communicating with Physicians, database reports).
* Aides in regulatory submissions and assists Regulatory Specialist as needed.
* Assists Fellows and Physicians on research projects and data collection.
* Maintains temperature logs for drug closet, freezer and refrigerator. Reports any deviations. Checks and replaces batteries as needed.
* Performs administrative duties for the Research Department including answering phones, scheduling appointments, and ordering supplies.
* Telephone screening of patients.
* Screens research subjects with Coordinator assistance.
* Regular and predictable on-site attendance required.
* Works overtime as needed.
* Travels to other MAR locations as needed.
* Performs other duties as assigned.
Supervisory Responsibility
This position has no direct supervisory responsibilities.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Physical and Cognitive Demands
The physical and cognitive demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
* This position is very active and requires standing and walking all day in order to get patients and bring them to rooms, assist physicians and rotate assignments with other staff.
* While performing the duties of this job, the employee is regularly required to talk, communicate verbally in front of groups, one to one and over the telephone and in email.
* Occasional bending, kneeling, stooping, and crouching.
* Lift or move objects weighing over 15 pounds as needed.
* Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Working environment in exam rooms is often in moderate light.
* Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina.
* Ability to raise dominant arm above shoulder height to administer drops.
* Use senses to observe and examine patients, paying attention to detail.
* Works with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying and recording, storing and retrieving information.
* Using words to communicate ideas, reading with comprehension, writing reports or other documentation, teaching or training patients.
* Sustain physical contact with another person in order to guide them due to their diminished vision.
* Ability to follow through on plans or instructions.
Travel
Willingness to travel is required.
Required Education and Experience
* 1 year clinicalresearch experience or ophthalmic experience.
$44k-59k yearly est. 46d ago
Clinical Research Coordinator II
Iterative Health
Clinical research associate job in Toms River, NJ
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinicalresearch sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
ClinicalResearch Coordinator II
Iterative Health is a healthcare technology and services company powering the acceleration of clinicalresearch to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinicalresearch sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, experienced ClinicalResearch Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
Schedule all patient research visits and procedures consistent with protocol requirements
Conduct patient visits as outlined within each study protocol
Dispense study medication, collect vital signs and perform ECGs
Perform blood draws, process and ship specimens per study protocol and IATA regulations
Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
Act as point of contact for study participants
Adhere to Research SOPs, Good Clinical Practices, and the study protocols
Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
Ensure all safety data is reviewed by the PI in a timely manner
Maintain inventory of study equipment and supplies onsite at all times
Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance
Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
Schedule and prepare for monitor visits
Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
Complete and maintain case report forms per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
Perform quality work within deadlines with or without direct supervision
Interact professionally with other employees, customers and suppliers
Work effectively as a team contributor on all assignments
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
Medical Assistant, LPN, Associates or Bachelor's degree in a clinical or scientific-related discipline preferred
Minimum 3 years of clinicalresearch experience
Experience in phlebotomy preferred
Strong written and verbal communication skils
Ability to read, interpret, and apply clinic policies and research protocols
Ability to use standard office software
Must be able to lift up to 25 pounds
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
$51k-76k yearly est. Auto-Apply 36d ago
Clinical Research Coordinator
U.S. Urology New Jersey Practice
Clinical research associate job in Voorhees, NJ
About the Role
The ClinicalResearch Coordinator (CRC) is responsible for conducting and documenting clinicalresearch and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations.
What You'll Be Doing
Administratively and clinically coordinates a team to effectively conduct a minimum six clinical trials (level 1-3 clinicalresearch protocol) and evaluates/analyzes clinical data and trial results. Schedule, plan and participate in study monitoring visits and addresses any potential queries or deviations in accordance to the study contract. Acts as a liaison between sponsor and the research department.
In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures. Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria.
Acts as a study resource for patients and family. Discusses study protocols with patients and verifies the informed consent process and documentation. Addresses any questions or concerns the research patient may have regarding the study. Provides patient with written communication of their participation.
Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction.
Dispenses study medications in accordance to protocol requirements within his/her scope of practice. Performs Investigational Product accountability for accurate compliance.
Collects, processes and ships blood/urine specimens at scheduled times.
Supervisors scheduling of research patient visits and procedures consistent with protocol requirements. Performs study specific procedures, including but not limited to ECG's, vital signs, height, weight, injections etc. within his/her scope of practice.
Collect, compile and maintain source documentation. Completes and maintains case report forms per FDA guidelines while ensuring source completeness and accuracy. Prepares and participates in quality assurance audits by study sponsors, federal agencies, or specially designated review groups.
Responsible for the reporting of and follow up on adverse events and serious adverse events per study protocol.
Screens all laboratory and radiographic results following protocol procedures regarding abnormal results assuring that all results are reviewed by a physician, PI or SI for clinical significance.
Contacts outside health care providers and communicates with subjects to obtain follow up information.
Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
Ensures filing and maintenance of all regulatory documents.
Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums.
Maintains required continuing education hours required for certifications.
Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS).
Maintains a high level of patient confidentiality.
Performs all other duties as assigned.
What We Expect from You
Associates or Bachelor's Degree from an accredited college or university.
Good Clinical Practice (GCP) Certificate
International Air Transport Association (IATA) Certificate
CCRC certification through an accredited organization (ACRP/SoCRA) is required
2-3 years related Research experience Preferred.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills
To perform this job successfully, an individual should have thorough knowledge in computer information systems.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Travel
Travel is primarily local during the business day, although some out-of-the-area and overnight travel may be expected.
Salary Range
$17- $22 per hour
The compensation range listed reflects the anticipated base pay for this position. Actual compensation will be determined based on factors such as relevant experience, education, skills, and work location.
What We are Offer You
At U.S. Urology Partners, we are guided by four core values. Every associate living the core values makes our company an amazing place to work. Here “Every Family Matters”
Compassion
Make Someone's Day
Collaboration
Achieve Possibilities Together
Respect
Treat people with dignity
Accountability
Do the right thing
Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more.
About US Urology Partners
U.S. Urology Partners is one of the nation's largest independent providers of urology and related specialty services, including general urology, surgical procedures, advanced cancer treatment, and other ancillary services. Through Central Ohio Urology Group, Associated Medical Professionals of NY, Urology of Indiana, and Florida Urology Center, the U.S. Urology Partners clinical network now consists of more than 50 offices throughout the East Coast and Midwest, including a state-of-the-art, urology-specific ambulatory surgery center that is one of the first in the country to offer robotic surgery. U.S. Urology Partners was formed to support urology practices through an experienced team of healthcare executives and resources, while serving as a platform upon which NMS Capital is building a leading provider of urological services through an acquisition strategy.
U.S. Urology Partners is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.
$17-22 hourly Auto-Apply 13d ago
Clinical Research Assistant
Astera Cancer Care 4.0
Clinical research associate job in East Brunswick, NJ
Why Join Us?
For us, what matters most is excellence. We are caring professionals, people who live, work and dedicate themselves to the communities within New Jersey and Pennsylvania. As such, we strive to provide a sanctuary of excellence, precision, thoroughness and genuine compassion. We also take a whole-person approach to patient care and treatment, tailoring all that we do around their unique needs. And we do all we can for patients, going the extra mile to see that they're supported, informed and getting the one-on-one care and service they deserve.
Job Description:
As an Oncology ClinicalResearch Assistant (CRA), you will be assisting team members at Astera Cancer Care on recruiting participants, collecting and managing the study data for the successful management of clinical trials. This is a full-time position.
Responsibilities Include:
Assisting ClinicalResearch Coordinator (CRC) to ensure that clinicalresearch activities are performed in accordance with local and federal regulations and adhere to policies and procedures of Astera and the sponsors and CROs
Assisting CRC on the coordination of tests and visits for patients and maximizing work efficiency and productivity.
Assisting Regulatory Specialist (RS) on IRB submissions and interact to maintain regulatory documents and administrative files for each protocol.
Assisting CRC on confirming patient's eligibility into clinical trials.
Assisting Clinical Data Coordinator (CDC) and RS on maintaining patient and regulatory research records.
Confer with all members of the clinical team to confirm appropriateness and timeliness of tests.
Collect follow-up data on patient's post-treatment as required by the protocol.
Assisting CDC on entering research data into a centralized database as per protocol requirements.
Prepare other study materials as requested by the Principal Investigator such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs.
Qualifications:
A Bachelor's degree preferred.
Experience with Microsoft applications.
Able to travel between offices within the offices in Northeast Jersey area.
Excellent communication skills.
Excellent time management skills.
$40k-55k yearly est. Auto-Apply 60d+ ago
Clinical Research Associate
Summit Therapeutics Sub, Inc.
Clinical research associate job in Princeton, NJ
Job Description
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The ClinicalResearchAssociate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial.
Role and Responsibilities:
Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
Initiates and builds solid professional relationships with clinical site staff
Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
Creation and development of study trackers
Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc.
Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
Following and implementing assigned study related plans, processes, agreements, and guidelines
Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
Reviews and approves essential document packages to enable timely site activations.
Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
Ensures the study is “inspection ready” contemporaneously
Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
A minimum of 3+ years of clinicalresearch experience in conducting clinical trials
Prior phase II or III experience required
A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
Experience with clinical studies oncology and / or rare diseases a plus
Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
Tenacity to work in a fast-paced team environment
Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships
Ability to successfully engage and work collaboratively with global team members/colleagues
Ability to support building and delivery of patient enrolment strategies
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
Ability to review and assess clinical data
Possesses excellent planning, time management & coordination skills.
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
Experience in working in a small organization a plus
Excellent written and oral communication skills
The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit's Talent Acquisition team at ********************* to obtain prior written authorization before referring any candidates to Summit.
$97k-114k yearly Easy Apply 24d ago
Clinical Research Associate
Systimmune, Inc.
Clinical research associate job in Princeton, NJ
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are seeking a motivated ClinicalResearchAssociate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements.
This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers.
Responsibilities
* Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits.
* Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries.
* Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts.
* Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders).
* Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned.
* Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy.
* Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level.
Qualifications
* Bachelor's degree in health sciences or related field.
* 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC).
* Exposure to oncology trials.
* Knowledge of ICH-GCP guidelines and regulatory requirements.
* Strong organizational skills, attention to detail, and ability to work both independently and within a team.
* Willingness to travel regionally (approx. 50%-75%).
Preferred
* 1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role.
* Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance.
* Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight.
Compensation and Benefits:
The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
$60k-90k yearly 11d ago
Clinical Research Associate
Systimmune
Clinical research associate job in Princeton, NJ
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are seeking a motivated ClinicalResearchAssociate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements.
This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers.
Responsibilities
Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits.
Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries.
Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts.
Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders).
Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned.
Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy.
Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level.
Qualifications
Bachelor's degree in health sciences or related field.
1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC).
Exposure to oncology trials.
Knowledge of ICH-GCP guidelines and regulatory requirements.
Strong organizational skills, attention to detail, and ability to work both independently and within a team.
Willingness to travel regionally (approx. 50%-75%).
Preferred
1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role.
Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance.
Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight.
Compensation and Benefits:
The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
$60k-90k yearly Auto-Apply 9d ago
Clinical Research Associate
Summit Therapeutics Plc 4.5
Clinical research associate job in Princeton, NJ
Site
4
days
per
week
at
our
Princeton
NJ
or
Miami
FL
Summit
Summit
Therapeutics
Inc
is
a
biopharmaceutical
oncology
company
with
a
mission
focused
on
improving
quality
of
life
increasing
potential
duration
of
life
and
resolving
serious
unmet
medical
needs
At
Summit
we
believe
in
building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology Summit has multiple global Phase 3 clinical studies including Non small Cell Lung Cancer NSCLC HARMONi Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who were previously treated with a 3rd generation EGFR TKIHARMONi 3 Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLCHARMONi 7 Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLCColorectal Cancer CRC HARMONi GI3 Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration NMPA Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland Overview of Role The ClinicalResearchAssociateCRAisresponsible for Supporting all aspects of Clinical Trial Management for complex global studies from study planning and start up through study close out This role will collaborate withfunctional team members CROsand vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or DirectorThe CRAis responsible foradherenceto all performance metrics and quality of deliverables in the clinical trial Role and Responsibilities Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained remain current with project requirements and have a thorough understanding of study milestones and deliverables Reviewapprovetrack vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites Initiates and builds solid professional relationships with clinical site staff Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high quality data Creationand developmentof study trackers Develop and provide clear complete documentation of study specific meetings actionitemsand action item closure for assigned study meetings Responsible for the development and management of clinical trial documents including but not limited to consent documents site welcome packets study binders etc Responsible for reviewing assigned study related plans processes agreements and guidelines Following and implementing assigned study related plans processes agreements and guidelines Responsible for requesting and logging CRO and vendor RFIs RFPs contractswork orders and specifications to enable studyobjectivesto be met Reviews and approves essential document packages to enabletimelysite activations Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed Assess and support investigator performance guidance and adherence to protocol and proactively addresses conduct issues andenrollmentproblems as necessary Responsible for oversight on the maintenance of the TMF and completeness at the end of the study Perform periodic QC of the TMF Oversee the execution of clinical trial activitiesin accordance with Good Clinical Practices Ensures compliance of clinical trials with national regulatory requirements and co monitoring the assigned clinical trial following company SOPs Ensures the study is inspection ready contemporaneously Responsible for supporting functional activities of Clinical Trial Associatesallocatedto the project through leadership and training as indicated and appropriate All other duties as assigned Experience Education and Specialized Knowledge and Skills Bachelors degree or equivalent in life science nursing pharmacy medical laboratory technology or other healthmedical related area preferred A minimum of 3years of clinicalresearch experience in conducting clinical trials Prior phase II or III experiencerequired A solid understanding of the recruitment methods drug development process ICH guidelines GCP and specifically each step within the clinical trial process Experience with clinical studies oncology and or rare diseases a plus Sophisticated understanding and highlyskilfulutilizationof Microsoft Apps such as Outlook Word Excel and Teams Ability to travel internationally to visit clinical sites and for study meetings Amount will vary upon project needs up to 20 Tenacity to work in a fast paced team environment Enjoys building relationships with KOLs and site personnel Willing to travel toestablishrelationships Ability to successfully engage and work collaboratively with global team memberscolleagues Ability to support building and delivery of patientenrolmentstrategies Excellent interpersonal anddecision makingskills Demonstrates innovationpossessesdriveenergyand enthusiasm to deliver the programobjectives Ability to review and assess clinical data Possesses excellent planning time management & coordination skills Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements interactions with external parties timelines and complex clinical programs Experience in working in a small organization a plus Excellent written and oral communication skills The pay range for this role is 97000 114000 annually Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location This may be different in other locations due to differences in the cost of labor The total compensation package for this position may also include bonus stock benefits andor other applicable variable compensation Summit does not accept referrals from employment businesses andor employment agencies in respect of the vacancies posted on this site All employment businessesagencies are required to contact Summits Talent Acquisition team atrecruitingsmmttxcomto obtain prior written authorization before referring any candidates to Summit
$52k-84k yearly est. 25d ago
Research Coordinator
Regional Cancer Care Associates 4.2
Clinical research associate job in Howell, NJ
Are you ready to be a pivotal force in groundbreaking cancer research? RCCA is in search of an outstanding Research Coordinator who will serve as the main point of contact and oversee each assigned clinical trial from start to finish. Under the guidance of the Clinical Trial Management.
We're seeking someone with a knack for multitasking, a positive outlook, and an undeniable passion for making a difference. If you're eager to join a team that's leading the charge in cutting-edge cancer care and places the patient at the forefront, we want to hear from you!
Employment Type: Full Time
Location: Howell, NJ
Compensation: $27.09 - $36.54 per hour
Compensation packages based on your unique skills, experience, and qualifications
As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities.
We believe these benefits underscore our commitment to the well-being and professional growth of our employees.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Demonstrate understanding of the protocol elements and requirements.
Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial
Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality.
Screening, recruit, enroll prospective patients using EMR, EDC, CTMS
Create and maintain enrollment logs for each trial from beginning to end
Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial.
Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial.
Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance.
Enter all the data to EDC, and EMR within 24 hours of data collection.
Communicate and resolve all the data queries within 5-days
Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents
Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times.
Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP
Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements.
Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues.
Supports internal and external audits
Ability to take initiative to resolve protocol-related concerns and discrepancies. Generate solutions to barriers and opportunities for improvements.
Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions.
Conduct clinical trial weekly and monthly meetings within the division.
Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings.
Track and submit clinical trial patient reimbursement.
Other duties as assigned.
Requirements
Minimum Job Qualifications:
Minimum 1 year of experience with oncology interventional clinical trials.
ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified ClinicalResearch Professional with one year of oncology trial experience.
High School diploma with four years of oncology clinical trial experience.
Computer literate with good interpersonal, writing, and verbal communication skills.
Previous regulatory affairs experience is a plus.
Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network.
Prior experience working with centrifuge and handling biofluid specimens is preferred.
Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure.
Working Conditions:
Traditional office environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment.
Physical Requirements (Lifting, standing, etc.)
Large percent of time performing computer based work is required
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.
Salary Description $27.09 - $36.54
$27.1-36.5 hourly 60d+ ago
Clinical Research Assistant
Mid Atlantic Retina 3.9
Clinical research associate job in Cherry Hill, NJ
This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires.
Job Description
The primary responsibility of the Research Assistant is to assist the Research Unit in conducting clinical trials. The Research Assistant is responsible for collecting and processing clinical data and providing administrative support to the Research Team.
Essential Functions
Assists the Research Coordinator with the conduction of clinical trials and patient flow.
Accurately collects clinical data on research patients. Maintains and updates information in data base.
Assists Coordinator with monitor preparation and follows up on any action items and query resolution.
Assists in trial recruitment (chart reviews, communicating with Physicians, database reports).
Aides in regulatory submissions and assists Regulatory Specialist as needed.
Assists Fellows and Physicians on research projects and data collection.
Maintains temperature logs for drug closet, freezer and refrigerator. Reports any deviations. Checks and replaces batteries as needed.
Performs administrative duties for the Research Department including answering phones, scheduling appointments, and ordering supplies.
Telephone screening of patients.
Screens research subjects with Coordinator assistance.
Regular and predictable on-site attendance required.
Works overtime as needed.
Travels to other MAR locations as needed.
Performs other duties as assigned.
Supervisory Responsibility
This position has no direct supervisory responsibilities.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Physical and Cognitive Demands
The physical and cognitive demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position is very active and requires standing and walking all day in order to get patients and bring them to rooms, assist physicians and rotate assignments with other staff.
While performing the duties of this job, the employee is regularly required to talk, communicate verbally in front of groups, one to one and over the telephone and in email.
Occasional bending, kneeling, stooping, and crouching.
Lift or move objects weighing over 15 pounds as needed.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Working environment in exam rooms is often in moderate light.
Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina.
Ability to raise dominant arm above shoulder height to administer drops.
Use senses to observe and examine patients, paying attention to detail.
Works with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying and recording, storing and retrieving information.
Using words to communicate ideas, reading with comprehension, writing reports or other documentation, teaching or training patients.
Sustain physical contact with another person in order to guide them due to their diminished vision.
Ability to follow through on plans or instructions.
Travel
Willingness to travel is required.
Required Education and Experience
1 year clinicalresearch experience or ophthalmic experience.
Job Posted by ApplicantPro
$44k-59k yearly est. 16d ago
Clinical Research Coordinator I
Cenexel 4.3
Clinical research associate job in Marlton, NJ
About Us:
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinicalresearch managers with a history of success.
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel ClinicalResearch also provides highly competitive compensation of $28-33/h, and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
Job Summary:
Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.
Compensation: $28-33/h depending on experience, education and skillset
Essential Responsibilities and Duties:
Assists with coordinating all aspects of patient involvement from study initiation until study completion.
Organizes research information for clinical trials.
Observes subjects and assists with data analysis and reporting.
Schedules the collection of data.
Documents adverse events, protocol deviations, and other unanticipated problems appropriately.
Reports research data to maintain quality and compliance.
Performs administrative and regulatory duties related to the study as appropriate.
Participates in other protocol development activities.
Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
Educates potential participants and caregivers on protocol specific details and expectations.
Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
Education/Experience/Skills:
High school graduate or equivalent; Bachelors Degree, preferred.
0-3 years of experience in the medical field.
Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.
Strong leadership and mentorship skills.
Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.
Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.
Works independently as well as functioning as part of a team.
Must be able to effectively communicate verbally and in writing.
Working Conditions
Indoor, Office environment.
Shift work, depending on location.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds.
Reporting to work, as scheduled, is essential.
Overnight travel may be required for training and/or investigative meetings.
CenExel ClinicalResearch is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
$28-33 hourly 40d ago
Clinical Research Associate
Systimmune
Clinical research associate job in Princeton, NJ
Job DescriptionSystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
We are seeking a motivated ClinicalResearchAssociate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements.
This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers.
Responsibilities
Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits.
Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries.
Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts.
Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders).
Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned.
Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy.
Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level.
Qualifications
Bachelor's degree in health sciences or related field.
1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC).
Exposure to oncology trials.
Knowledge of ICH-GCP guidelines and regulatory requirements.
Strong organizational skills, attention to detail, and ability to work both independently and within a team.
Willingness to travel regionally (approx. 50%-75%).
Preferred
1-5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role.
Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance.
Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight.
Compensation and Benefits:
The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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How much does a clinical research associate earn in Barnegat, NJ?
The average clinical research associate in Barnegat, NJ earns between $43,000 and $101,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.
Average clinical research associate salary in Barnegat, NJ