Clinical Supply Operations Specialist
Clinical Research Associate Job 19 miles from Elmont
Clinical Supply Operations Specialist - Contract - Basking Ridge, NJ
Ready to lead projects that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!
Proclinical is seeking a Clinical Supply Operations Specialist to support the distribution process of Investigational Products (IP) and ancillary supplies across various therapeutic areas.
Primary Responsibilities:
The successful candidate will be involved in managing moderately complex studies, short-term projects, and continuous improvement initiatives. You will ensure activities are completed on time, within budget, and meet quality standards in compliance with regulatory guidelines.
Skills & Requirements:
Understanding of clinical drug development and trial methodology
Knowledge of ICH/GCP and regulatory guidelines
Proficiency in MS Word and Excel
Strong problem-solving and time management skills
Ability to thrive in ambiguity and adapt to changes
Excellent collaboration, communication, and organizational skills
Detail-oriented approach
Bachelor's Degree in a relevant field with experience in clinical supplies, QA/regulatory, precision medicine, supply chain, or manufacturing
The Clinical Supply Operations Specialist's responsibilities will be:
Plan and manage IP supply and inventory
Handle accountability, reconciliation, returns, and destruction processes
Manage internal systems for lot creation, batch status, and inventory maintenance
Conduct assessment and oversight activities, including risk management and trend analysis
Coordinate IP shipments and depot transfers
Manage temperature excursions and supply monitoring
Document activities in the Electronic Trial Master File (eTMF)
Create and manage expected document lists per regulatory requirements
Oversee QA/QP release management and inspection readiness
Reconcile pack-and-label kits and sequences
Manage IRT activities, including alerts and user acceptance testing
Support suspected serious non-compliance issues
Plan and manage ancillary supply and inventory
Provide procurement support and manage shipping logistics
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
Director of Clinical Oncology Research
Clinical Research Associate Job 12 miles from Elmont
Physician Affiliate Group of New York (PAGNY) at Lincoln Medical Center, a leading community hospital in the South Bronx, is seeking a Board-Certified/Board-Eligible Hematologist-Oncologist to serve as the Director of Clinical Oncology Research. This role combines clinical excellence, leadership in oncology research, and teaching responsibilities in a dynamic academic environment. The Director will lead and expand clinical trials and translational research programs while also providing compassionate patient care. New/Recent graduates are welcome. Lincoln Medical Center is affiliated with Weill Medical College of Cornell University.
The Mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and has established the ICARE standards for all staff. NYC Health + Hospitals is the nation's largest municipal health care delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, and regardless of immigration status or ability to pay.
The Hematology/Oncology division is part of the Department of Medicine. It provides adult inpatient consultations across the hospital and runs a busy hematology/oncology outpatient service and infusion center.
Teaching & Mentorship:
Work closely with Internal Medicine residents
Oversee and mentor Hematology/Oncology fellows rotating from New York Medical College
Position Highlights:
Academic Appointment: Affiliation with Weill Cornell Medical College
State-of-the-art facilities including a busy 11-chair infusion center
Schedule & Call:
Monday through Friday, 8-hour shifts
On-call coverage is phone-based only
Research & Clinical Balance:
0.3 FTE dedicated to cancer research
0.7 FTE dedicated to clinical Hematology/Oncology practice
Participation in oncology clinical research required, with an opportunity to serve as the local Principal Investigator
Qualifications
MD/DO degree from an accredited institution.
Board Certified / Eligible in Hematology-Oncology.
Eligible for medical licensure in New York.
Experience in clinical trials, translational oncology research, or investigator-initiated studies.
Strong commitment to academic medicine, mentorship, and patient-centered cancer care.
Preferred (not required): Track record of peer-reviewed publications and research funding.
Experience in early-phase trials, immunotherapy, or precision oncology.
Leadership experience in an academic or clinical research setting is preferred but not required.
This position offers an attractive compensation & benefits package; excellent work/life balance; clinical research and teaching opportunities; flexible starting date and schedule; reasonable call schedule.
Wages and Benefits include:
Annual Base Salary: $375,000* based on 40-hour work week. Additional compensation available for extra call or sessional/per diem hours.
The annual total value of the compensation package is estimated at $450,000**, which includes the baseline salary, 401(k) contribution, and other factors as set forth below:
Projected bonus of up to $40,000 (based on previous year's average), contingent upon meeting quality and productivity targets.
401(k) Company Contribution (subject to IRS contribution limits):
Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required.
After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required.
Annual Continuing Medical Education (CME) Reimbursement.
Generous Annual Paid Time Off (PTO): Vacation, Sick, Holiday, and CME days.
Medical, Prescription, and Dental Coverage: Top-tier plans with employee contributions significantly below market rates.
Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 2x your salary (up to a maximum of $300,000) provided at no cost to you.
Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family.
Loan Forgiveness: Position may be eligible for loan forgiveness through certain state or federal programs.
Medical Malpractice Coverage (equivalent to occurrence-based): Provided at no cost to the employee.
Healthcare and Dependent Care Flexible Spending Accounts (FSAs).
Pre-tax employee-paid contributions for commuting expenses.
Visa sponsorship will be considered for this position.
Physician Affiliate Group of New York, P.C. (PAGNY) mission is to provide accountable, responsive, quality care with the highest degree of sensitivity to the needs of the diverse population that lives in our New York Community. PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Our providers are highly skilled professionals with outstanding credentials who deliver the highest level of quality healthcare to patients throughout New York City.
Physician Affiliate Group of New York, P.C. (PAGNY) is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. We are committed to fostering an inclusive environment where everyone feels valued and respected. Our policies ensure equal opportunities for all. Learn more about our initiatives by visiting our Diversity, Equity, and Inclusion page.
*Salary Disclosure Information:
The annual base salary listed complies with the New York City law on Salary Transparency in Job Advertisements. The annual base salary listed is for full-time employment and does not include bonuses/incentive compensation or benefits. Actual total compensation depends on many factors, including experience, specialties, historical productivity, and historical collections.
**The annual total value of the compensation package shown is provided as an illustration and is not guaranteed.
Apply for this opportunity
Click the button below to visit our job portal and fill out an application for this opportunity.
#J-18808-Ljbffr
BMT Oncology Research Nurse Practitioner Float
Clinical Research Associate Job 21 miles from Elmont
Job Description
Oncology Clinical Research NP for Bone Marrow Transplant - Northern New Jersey: Embrace a Rewarding Career at a Cancer Center within an Academic Environment
Are you a talented Oncology Clinical Research APN looking for a rewarding opportunity in Northern New Jersey? We have the perfect roles for you! Join our dynamic Clinical Research Organization and be part of our esteemed oncology clinical research team in the heart of Northern New Jersey.
Position Overview:
4-10 hour shifts (No weekends)
The Oncology APN plays a critical role in promoting and providing clinical excellence to the oncology patient, their families and significant others.
The Oncology APN functions in the CNS, NP or blended role as an integral part of the Oncology interdisciplinary healthcare team.
This role includes assessing, diagnosing, planning and prescribing pharmacological (in a collaborative practice) and non-pharmacological treatment for health problems according to established protocols, standards of care, health promotion and preventive care within the oncology spectrum.
Promote compliance with Federal Regulations, Good Clinical Practice (GCP), and Institutional policies.
Act as a liaison to investigators, collaborating divisions, departments, institutions, the Institutional Review Board (IRB), and external regulatory agencies.
Attend and actively participate in study team meetings, sponsor meetings, research meetings, and conferences/in-service education sessions as required.
Qualifications:
NJ - APN licensed required or willing to obtain.
Prefer someone with Oncology NP experience.
Will consider New grad if extensive Oncology RN experience.
Benefits:
Competitive salary. Pay similar to NYC organizations.
Great PTO accrual rate
Medical, Dental, and Vision with fantastic premiums
Flex spending account
401a and 403b
Temporary, Short Term, and Long-Term Disability
Tuition assistant program
College savings program
Many other discounts and programs
Working at this Cancer Center:
Cutting-Edge Research: Be part of groundbreaking oncology research at a prestigious Cancer Center, contributing to advancements in cancer treatment and patient care.
World-Class Facilities: Work in state-of-the-art facilities equipped with the latest technologies and resources, enhancing your ability to deliver high-quality research outcomes.
Collaborative Environment: Collaborate with leading oncologists, researchers, and experts in the field, fostering a dynamic and enriching academic environment.
Join Our Team:
At our Clinical Research Organization, you'll have the opportunity to work with a dedicated team, contribute to cutting-edge research, and make a difference in the field of oncology. If you have a passion for clinical research and compliance with a focus on oncology, we encourage you to apply and be part of our impactful journey.
Don't miss out on this exciting opportunity! Join our team and embark on a rewarding career in oncology clinical research within the thriving community of Northern New Jersey and an esteemed Cancer Center. Apply now and take the next step towards a fulfilling and meaningful role in the heart of the Garden State.
Why Northern New Jersey:
Experience the Charm of the Garden State: Northern New Jersey offers a blend of urban sophistication and scenic beauty. Explore its vibrant culture, culinary delights, and beautiful parks and hiking trails, all within a short drive from your workplace.
Clinical Research Associate II
Clinical Research Associate Job 25 miles from Elmont
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Clinical Research Associate-IVI
Clinical Research Associate Job 12 miles from Elmont
This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.
Under general supervision, the Clinical Research Associate - IVI is responsible for performing series of qualitative and quantitative analyses of patient intravascular image (IVI)s.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Acts as a point person for assigned trials
Responsible for setting up new trial documentation, Case Report Forms, Technician Worksheets; uses templates and revises for assigned client
Becomes familiar with protocols and sub study for assigned client. Creates or revises, as needed, for review by Medical Director and Assistant Director, IVI
Creates initial database/excel spreadsheet to track work
Acquires images, logs work that is being completed
Archives, digitizes, controls the quality, and performs measurements and image interpretation of intravascular ultrasound (IVUS), Virtual HistologyTM (VH)-IVUS, optical coherence tomography (OCT), near infrared spectroscopy (NIRS), and physiology recordings received in the core lab, related to ongoing contracted studies
Follows training IVUS, VH-IVUS, OCT, NIRS, physiology and any other intravascular imaging modalities to maintain consistency of readings
Responsible for analysis of assigned trials
Receives and answers queries; contacts site coordinators or PIs and works with the sponsor to resolve issues
May be responsible for data management activities
Responsible for additional research, presentation, and academic activities as assigned
Initially works in catheterization laboratory once a week or at department director's discretion to understand how to set up the ultrasound scanner, perform on-line measurements and understand basic coronary anatomy and principle of percutaneous interventions
Additional duties as assigned
QUALIFICATIONS
B.A. or B.S. degree in Biomedical Engineering or Life Sciences
0 - 2 years working experience in a medical, academic or pharmaceutical environment
Knowledge of medical terminology and morphology of the heart preferred
Must be proficient in Microsoft Excel, Word, and Outlook
Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment
Ability to verbally communicate effectively with staff, physicians, nurses, managers, trial sponsors and colleagues. Ability to communicate effectively when reading and writing e-mail, letters, Manual of Operations, Case Report Forms and other reports or company documents
Ability to analyze information and solve problems relating to intravascular images
BENEFITS
Choice of health plans include medical, Dental, and vision coverage
Company-paid short-term and long-term disability and life insurance
Health and dependent care flexible spending accounts
Pre-tax travel expenses through TransitChek program
401(k) plan
Generous paid time off (PTO)
Ten paid holidays each year
COMPENSATION The hiring range for this position is $52,000 - $58,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.
CONTACT INFORMATION
To be considered for this opportunity, please submit your resume.
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day ***********
CRF is an equal opportunity employer.
Clinical Research Associate
Clinical Research Associate Job 29 miles from Elmont
Responsible for pre-clinical trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and transmittal, data collection and management, adverse event management to ensure protocol compliance in conjunction with the PI, clinical team and clinical research nurses and team.
Responsibilities
Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi-institutional protocols.
Screen and enroll patients onto clinical trials in collaboration with clinical team, ensure protocol compliance; coordination of specimen collection and transmittal in collaboration with clinical team.
Ensure compliance with the Good Clinical Practice guidelines in clinical research.
Monitor study patients for adverse events in collaboration with clinical team and report as required.
Enter data on Hematology, Oncology and Stem Cell Transplant patients on electronic data capture forms; prepare for routine data audits and maintain source documents and regulatory binders. Manage communications- mail, phone, fax, e-mail for COG, sponsored, local and multi-institutional studies. Act as liaison between NYMC and Westchester Medical Center, regarding new study requirements.
Qualifications
Education requirement: BS
Other skills/requirements: Must have a keen attention to detail, be able to multi-task and prioritize assignments.
Minimum Salary USD $48,000.00/Yr. Maximum Salary USD $60,000.00/Yr.
Clinical Research Scientist
Clinical Research Associate Job 19 miles from Elmont
Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's
oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will
provide
leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion.
The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors.
He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible.
Job Description
Prepare clinical-related documents with minimal supervision and routine documents independently as directed.
Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory
submissions such as INDs.
Author abstracts and manuscripts for publication in peer-reviewed journals.
Evaluate and select potential investigative sites in collaboration with Clinical Operations staff.
Ability to prepare, present and defend complex aspects of protocol design and/or study data at
investigator and internal meetings.
Oversee and coordinate the collection of and/or collect pre-study documents
Participate in data review and discrepancy resolution, team meetings/presentations with increasing
levels of independence and support the Program Clinical Leader or Sr. Management as needed.
Assist in managing regulatory safety reporting with the following: SAE queries and follow-up,
annual reports, investigator brochures, ability to learn various databases.
Critically review and synthesize complex information from reviews of the scientific and clinical
literature.
Qualifications
Minimum 2-5 years of pharmaceutical industry clinical trial experience.
Experience in immunology or endocrinology therapeutic areas is a plus.
Primary experience with development of clinical trial protocols.
Medical or scientific writing experience a must and familiarity with clinically applied science or
pharmaceutical development.
Good understanding of FDA regulatory, ICH, and GCP requirements.
Excellent communication skills, written and verbal.
Superior interpersonal communication and the ability to work across company disciplines and functional units.
Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
Attention to detail and a commitment to high quality and on-time deliverables are key success factors.
Willingness to travel up to 30% domestically and internationally.
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.
At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off
Senior Clinical Research Coordinator
Clinical Research Associate Job 25 miles from Elmont
WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.
We are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients' mission to impact and save lives.
Reasons to work for Vitalief:
You can actively contribute to our clients' mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
We give everyone a seat at the table - we encourage innovation.
Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.
Salary Range: Market competitive - based on experience level.
Work Location: Work is 5 days per week on-site in Newark, NJ. Possibility of working one day remote per week after acclimated.
Responsibilities:
Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Oncology trials.
Serves as a liaison (Communicating effectively) between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors - to ensure that services are coordinated and delivered to patients in a timely manner.
Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials.
Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms.
Schedules and conducts trial visits by informing patients and coordinating procedures per protocol.
Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol.
Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies.
Required Skills:
Bachelor's Degree required.
Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol.
Oncology clinical research experience is a huge plus.
Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines.
Compassionate personality and ability to interact with patients in a clear and confident manner.
Ability to work on several trials concurrently - can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills.
Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner.
Needs to be communicative and responsive and know when to escalate and communicate issues to management.
Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently.
Must have strong Microsoft Office skills.
Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
#LI-DNP
Sr. Clinical Research Coordinator
Clinical Research Associate Job 12 miles from Elmont
The Clinical Research Coordinator is responsible for coordinating the initiation and activation of all new clinical trial protocols. This role involves developing study tools, reviewing patient charts, confirming protocol eligibility, and maintaining research records. Collaboration with Research Nurse Clinicians and physicians is crucial to ensure informed consent and accurate documentation. Additionally, the role includes grading adverse events, completing serious/unexpected adverse event forms, and liaising with study sponsors.
Responsibilities
+ Coordinate the initiation and activation of all new clinical trial protocols.
+ Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.
+ Develop study tools using Oncore , Excel , and Word, including eligibility checklists, medication diaries, calendars, and flow sheets.
+ Review patients' charts and medical history to confirm protocol eligibility and obtain necessary source documents.
+ Ensure IRB approved informed consent forms are obtained, signed, and correctly filed.
+ Maintain research records for all enrolled patients, including patient consent, eligibility, and corresponding source documents.
+ Assist with grading adverse events using NCI common toxicity criteria or protocol-specific grading scales.
+ Complete Serious/Unexpected Adverse Event forms as required by study sponsors and institutional guidelines.
+ Provide regular reports to tumor study group members and Principal Investigator using Oncore .
+ Serve as study liaison with study sponsors, scheduling monitoring visits and conference calls.
Essential Skills
+ Minimum of 4 years of clinical research experience.
+ Minimum of 4 years of oncology experience.
+ Experience working in multiple EDC systems such as Medidata and Inform.
+ Experience in data management, responsible for 60% of the role.
+ Experience recruiting, screening, and consenting patients for clinical trials.
Additional Skills & Qualifications
+ Bachelor's Degree minimum.
+ Experience in blood processing.
+ Experience from gynecology oncology group or nursing is acceptable.
Work Environment
The position requires on-site presence in the Bronx four times a week.
Pay and Benefits
The pay range for this position is $35.00 - $39.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in bronx,NY.
Application Deadline
This position is anticipated to close on Jun 30, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Part-time Clinical On- Site Monitor
Clinical Research Associate Job 29 miles from Elmont
Berkeley College, a career-focused institution of higher education, seeks a part-time Clinical On-Site monitor to observe and document the clinical procedures Surgical Technology and Surgical Processing Technician students perform in the clinical environment. This individual will also serve as the liaison between the clinical sites and the College.
Primary Duties and Responsibilities
* Observe and document clinical procedures as performed in the clinical setting.
* Monitor case specialties of Surgical Technology students.
* Review clinical performance with each student.
* Review weekly student self-evaluations and skill assessments and advise as appropriate.
* Maintain clinical attendance logs.
* Serve as a liaison between the College and clinical affiliate staff.
* Meet with the Clinical Coordinator to discuss student performance.
* Occasional administrative work to be performed at the Woodland Park, NJ, campus upon request of the School Dean and/or Clinical Coordinator.
Job Location
The part-time staff position includes off-site visits to clinical sites as well as on-campus meetings and administrative work as requested by the School Dean and/or Allied Health Surgical Clinical Coordinator.
Educational Requirements
* Be a graduate of an educational program in surgical technology accredited by a nationally recognized programmatic accreditation agency.
* Possess a credential in the field of surgical technology through a national certification program that is accredited by the National Commission on Certifying Agencies (NCCA).
Training and/or Experience
* Have a minimum of three years of documented experience in the operating room scrub role or as an instructor in surgical technology, or a combination of both, within the past five years.
* Possession of a current unrestricted driver's license.
* Possess a current CST certification.
Knowledge, Skills & Abilities
* Knowledgeable in the competencies required for competent Surgical Technologists and Surgical Processing Technicians.
* Knowledgeable about the program's evaluation of student learning and performance.
* Skilled in Microsoft Office applications such as Word and Excel.
* Knowledge of learning management systems is preferred.
Hourly for this position is $40-$45
Miscellaneous
Mileage, tolls, and parking will be paid to the part-time Clinical Site Monitor and will be based on the College's reimbursement policy. The maximum number of hours worked each week shall not exceed 20, unless prior approval is received.
Berkeley College is committed to excellence in diversity and equity and the continuation of an inclusive learning and working environment. We are an Equal Opportunity Employer and consider applicants for all positions regardless of race, color, religion, creed, gender, age, national origin, marital and veteran status, disability, sexual orientation, gender identity or expression, or any other legally protected status. We believe in fostering inclusion, acceptance, and understanding in our community by employing individuals who bring unique perspectives to the college.
All interested individuals, including people of all races and national origin, people of all ages, people of all religions, people with or without disabilities, and/or people with any gender identity and sexual orientation, are urged to apply.
Pre-Trial Specialist
Clinical Research Associate Job 16 miles from Elmont
Title: Pretrial Specialist
Reports To: Pretrial Supervisor
FLSA: Non-Exempt
Status: Full-time
Supervisory Responsibility: Not Applicable
Purpose of the Role:
Rapidly after release into the program, the Pretrial Specialist meets with new participants to review supervision conditions that will be required under the supervision plan. The Pretrial Specialist assists participants on their case load to comply with supervision appointments and court appearances during the pendency of their legal case, conducts ongoing service need assessments with participants and develops collaborative service plans ensuring participants receive services to achieve their self-identified needs and goals.
Essential Functions of the Role:
Provide supervision and community-based services to a caseload of pretrial participants
Rapidly (within 24-48 hours of release) conduct Supervision Introduction/Orientation meetings with new participants to review supervision conditions, the reporting schedule (as assigned by level of recidivism risk), and the mandatory methods of communication (face-to-face, telephone, and texts) that will be required under the participant's supervision plan.
Work collaboratively with the court and other pretrial staff team to facilitate and ensure caseload participants' successful completion of mandated supervision appointments and court appearances during the pendency of their legal case.
Review legal and court screening documentation and work with participants to analyze their offending behavior patterns, identifying behavioral changes, need for implementation of supports that may reduce likelihood of any pretrial arrests.
On an ongoing basis, conduct service need assessments with participants to examine psychosocial needs and problems, including the severity of mental and substance use disorders, problems affecting participation, engagement, and continuity in supervision and treatment and individual motivation for treatment.
Link participants to treatment based on their eligibility, preferences and needs and provide escort to community services.
Ensure the timely flow of community outreach and case management activities to meet program goals and objectives.
Utilize problem solving techniques, motivational interviewing as an integral part of the pretrial supervision and case management process approach, to help motivate and engage individuals in any needed process of change.
Provide all services in a manner that is gender-responsive, trauma-informed, and that adheres to the core principles of risk-need-responsivity.
Maintain collaborative relationships with community providers (supported housing providers, Health Homes, care management programs, addiction treatment and mental health providers, peer-run providers, education, vocational training and employment services providers, legal services providers, medical care providers, and family providers)
Follow program community-based monitoring protocols for high risk and high need program participants and request/participate in case reviews to addresses complex cases.
Enter assessment, supervision appointment reporting, progress note documentation into program database; conduct all electronic charting activities and reporting in accordance with confidentiality regulations and in a timely fashion.
Meet monthly case management contact and outreach goals as established by supervisory staff
Decision Making Authority:
Decisions regarding Pretrial Services are to be made with guidance and collaboration of the Director to whom the Pretrial staff is assigned. It is expected that the Pretrial Specialist will show an increasing ability to make decisions independently on routine matters as knowledge and experience progresses.
Working Relationships:
Internal: Pretrial Supervisor, Director of Criminal Justice
External: Dept. of Social Services, Mental Health Providers, Primary Care Physicians, Parole Officers, Legal Services, District Attorney’s Office, Court Officials, Police Departments, etc.
Work Schedule: Monday – Friday, 9am – 5pm with some flexibility around client needs.
Physical Environment:
Traditional office environment.
Must be comfortable attending appointments at various courts, agencies, facilities and client’s homes.
Physical Demands: Must be able to drive a motor vehicle and carry up to 20 lbs.
Mental and Visual Demands: Flow of work and nature of duties involve normal coordination of mind and eyes much of the time.
Must be able to interact with persons having mental health issues, periods of instability (i.e. lack of shelter, food, clothing or support), recently released from an institution (i.e. hospital, prison), limited comprehension and/or ability to manage through complex scenarios
Qualifications for this Role:
Bachelors Degree or equivalent experience
Minimum of four years of experience working in human services with individuals with substance use disorders, co-occurring mental health and substance use disorders and involvement in the criminal justice system.
Extensive knowledge of community treatment, support services and resources
Knowledge of the criminal justice system, court processes and alternative to detention/incarceration services
Valid Driver License required and a driving record that will permit the use of an Agency vehicle to transport clients to appointments or other activities as needed.
Bachelor’s Degree required.
Associates accepted with experience.
Bilingual English/Spanish a plus.
Compensation Range: $45,000 - $48,000
Clinical Research Coordinator II
Clinical Research Associate Job 12 miles from Elmont
What We DoCare Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We AreWe care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. Position OverviewThe Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. What You'll Be Working OnDuties include but not limited to:● Ability to understand and follow institutional SOPs.● Review and assess protocol (including amendments) for clarity, logistical feasibility● Ensure that all training and study requirements are met prior to trial conduct.● Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.● Assist with planning and creation of appropriate recruitment materials.● Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.● Actively work with recruitment team in calling and recruiting subjects ● Attend Investigator meetings as required. ● Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.● Assist in the creation and review of source documents.● Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) Study Management:● Prioritize activities with specific regard to protocol timelines● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.● Maintain effective relationships with study participants and other care Access Research personnel.● Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.● Communicate clearly verbally and in writing. Patient Coordination:● Prescreen study candidates ● Obtain informed consent per Care Access Research SOP .● Complete visit procedures in accordance with protocol.● Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.● Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.● Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Documentation:● Record data legibly and enter in real time on paper or e-source documents ● Accurately record study medication inventory, medication dispensation, and patient compliance.● Resolve data management queries and correct source data within sponsor provided timelines● Assist regulatory personnel with completion and filing of regulatory documents.Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.Physical and Travel Requirements· This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. What You Bring Knowledge, Skills, and Abilities:● Excellent working knowledge of medical and research terminology● Excellent working knowledge of federal regulations, good clinical practices (GCP)● Ability to communicate and work effectively with a diverse team of professionals.● Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail● Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.● Critical thinker and problem solver● Friendly, outgoing personality; maintain a positive attitude under pressure.● High level of self-motivation and energy● Excellent professional writing and communication skills● Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience:● Bachelor's Degree preferred, or equivalent combination of education, training and experience.● A minimum of 3 years prior Clinical Research Coordinator experience required● Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator ● Recent phlebotomy experience required -Bilingual in Spanish-preferred
Benefits (US Full-Time Employees Only)· Paid Time Off (PTO) and Company Paid Holidays· 100% Employer paid medical, dental, and vision insurance plan options· Health Savings Account and Flexible Spending Accounts· Bi-weekly HSA employer contribution· Company paid Short-Term Disability and Long-Term Disability· 401(k) Retirement Plan, with Company Match Diversity & InclusionWe serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access, every day, we are advancing medical breakthroughs. We're uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We're proud to advance these breakthroughs and work with the big players while engaging with thephysicians and caring for patients. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is currently unable to sponsor work visas. Employment StatementCare Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Clinical Research Coordinator
Clinical Research Associate Job 24 miles from Elmont
Job Title : Clinical Research Coordinator
Department : Site Operations
Reports To : Site Manager
Status : Non-exempt (hourly)
Compensation : $17.00 - $19.00
: We are seeking a reliable and experienced Clinical Research Coordinator to join our growing team at Elite Clinical Network. This position will be responsible for collaborating with the Principal Investigator, human subjects, IRB, and pharmaceutical company to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Ideal candidates will possess working knowledge of clinical trial procedures.
Essential Duties:
Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
Provides accurate and timely data collection, documentation, entry, and reporting
Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Qualifications :
Bachelor's degree or certified Medical Assistant
If you are a dedicated and reliable Clinical Research Coordinator, we invite you to apply for this exciting opportunity. Join us and be a key player in shaping the future of our business.
ECN is an equal opportunity employer. We make every effort to make our hiring process accessible to all users. If you need assistance completing the application process, please contact Human Resources via *********************************
Clinical Research Associate II
Clinical Research Associate Job 12 miles from Elmont
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision and 401K
Senior Clinical Research Coordinator
Clinical Research Associate Job 25 miles from Elmont
Job Description
WHY VITALIEF? Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients.
We are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients’ mission to impact and save lives.
Reasons to work for Vitalief:
You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better.
Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees.
We give everyone a seat at the table – we encourage innovation.
Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually.
Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from.
Salary Range: Market competitive - based on experience level.
Work Location: Work is 5 days per week on-site in Newark, NJ. Possibility of working one day remote per week after acclimated.
Responsibilities:
Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Oncology trials.
Serves as a liaison (Communicating effectively) between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors – to ensure that services are coordinated and delivered to patients in a timely manner.
Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials.
Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms.
Schedules and conducts trial visits by informing patients and coordinating procedures per protocol.
Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol.
Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies.
Required Skills:
Bachelor’s Degree required.
Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol.
Oncology clinical research experience is a huge plus.
Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines.
Compassionate personality and ability to interact with patients in a clear and confident manner.
Ability to work on several trials concurrently – can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills.
Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner.
Needs to be communicative and responsive and know when to escalate and communicate issues to management.
Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently.
Must have strong Microsoft Office skills.
Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus.
PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs.
IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis.
#LI-DNP
Powered by JazzHR
LihdAEAgf2
Sr. Clinical Research Coordinator
Clinical Research Associate Job 12 miles from Elmont
The Clinical Research Coordinator is responsible for coordinating the initiation and activation of all new clinical trial protocols. This role involves developing study tools, reviewing patient charts, confirming protocol eligibility, and maintaining research records. Collaboration with Research Nurse Clinicians and physicians is crucial to ensure informed consent and accurate documentation. Additionally, the role includes grading adverse events, completing serious/unexpected adverse event forms, and liaising with study sponsors.
Responsibilities
* Coordinate the initiation and activation of all new clinical trial protocols.
* Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.
* Develop study tools using Oncore, Excel, and Word, including eligibility checklists, medication diaries, calendars, and flow sheets.
* Review patients' charts and medical history to confirm protocol eligibility and obtain necessary source documents.
* Ensure IRB approved informed consent forms are obtained, signed, and correctly filed.
* Maintain research records for all enrolled patients, including patient consent, eligibility, and corresponding source documents.
* Assist with grading adverse events using NCI common toxicity criteria or protocol-specific grading scales.
* Complete Serious/Unexpected Adverse Event forms as required by study sponsors and institutional guidelines.
* Provide regular reports to tumor study group members and Principal Investigator using Oncore.
* Serve as study liaison with study sponsors, scheduling monitoring visits and conference calls.
Essential Skills
* Minimum of 4 years of clinical research experience.
* Minimum of 4 years of oncology experience.
* Experience working in multiple EDC systems such as Medidata and Inform.
* Experience in data management, responsible for 60% of the role.
* Experience recruiting, screening, and consenting patients for clinical trials.
Additional Skills & Qualifications
* Bachelor's Degree minimum.
* Experience in blood processing.
* Experience from gynecology oncology group or nursing is acceptable.
Work Environment
The position requires on-site presence in the Bronx four times a week.
Pay and Benefits
The pay range for this position is $35.00 - $39.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in bronx,NY.
Application Deadline
This position is anticipated to close on Jun 30, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Pre-Trial Specialist
Clinical Research Associate Job 16 miles from Elmont
JOB DESCRIPTION
Title: Pretrial Specialist
Reports To: Pretrial Supervisor
FLSA: Non-Exempt
Status: Full-time
Supervisory Responsibility: Not Applicable
Purpose of the Role:
Rapidly after release into the program, the Pretrial Specialist meets with new participants to review supervision conditions that will be required under the supervision plan. The Pretrial Specialist assists participants on their case load to comply with supervision appointments and court appearances during the pendency of their legal case, conducts ongoing service need assessments with participants and develops collaborative service plans ensuring participants receive services to achieve their self-identified needs and goals.
Essential Functions of the Role:
Provide supervision and community-based services to a caseload of pretrial participants
Rapidly (within 24-48 hours of release) conduct Supervision Introduction/Orientation meetings with new participants to review supervision conditions, the reporting schedule (as assigned by level of recidivism risk), and the mandatory methods of communication (face-to-face, telephone, and texts) that will be required under the participant's supervision plan.
Work collaboratively with the court and other pretrial staff team to facilitate and ensure caseload participants' successful completion of mandated supervision appointments and court appearances during the pendency of their legal case.
Review legal and court screening documentation and work with participants to analyze their offending behavior patterns, identifying behavioral changes, need for implementation of supports that may reduce likelihood of any pretrial arrests.
On an ongoing basis, conduct service need assessments with participants to examine psychosocial needs and problems, including the severity of mental and substance use disorders, problems affecting participation, engagement, and continuity in supervision and treatment and individual motivation for treatment.
Link participants to treatment based on their eligibility, preferences and needs and provide escort to community services.
Ensure the timely flow of community outreach and case management activities to meet program goals and objectives.
Utilize problem solving techniques, motivational interviewing as an integral part of the pretrial supervision and case management process approach, to help motivate and engage individuals in any needed process of change.
Provide all services in a manner that is gender-responsive, trauma-informed, and that adheres to the core principles of risk-need-responsivity.
Maintain collaborative relationships with community providers (supported housing providers, Health Homes, care management programs, addiction treatment and mental health providers, peer-run providers, education, vocational training and employment services providers, legal services providers, medical care providers, and family providers)
Follow program community-based monitoring protocols for high risk and high need program participants and request/participate in case reviews to addresses complex cases.
Enter assessment, supervision appointment reporting, progress note documentation into program database; conduct all electronic charting activities and reporting in accordance with confidentiality regulations and in a timely fashion.
Meet monthly case management contact and outreach goals as established by supervisory staff
Decision Making Authority:
Decisions regarding Pretrial Services are to be made with guidance and collaboration of the Director to whom the Pretrial staff is assigned. It is expected that the Pretrial Specialist will show an increasing ability to make decisions independently on routine matters as knowledge and experience progresses.
Working Relationships:
Internal: Pretrial Supervisor, Director of Criminal Justice
External: Dept. of Social Services, Mental Health Providers, Primary Care Physicians, Parole Officers, Legal Services, District Attorney's Office, Court Officials, Police Departments, etc.
Work Schedule: Monday - Friday, 9am - 5pm with some flexibility around client needs.
Physical Environment:
Traditional office environment.
Must be comfortable attending appointments at various courts, agencies, facilities and client's homes.
Physical Demands: Must be able to drive a motor vehicle and carry up to 20 lbs.
Mental and Visual Demands: Flow of work and nature of duties involve normal coordination of mind and eyes much of the time.
Must be able to interact with persons having mental health issues, periods of instability (i.e. lack of shelter, food, clothing or support), recently released from an institution (i.e. hospital, prison), limited comprehension and/or ability to manage through complex scenarios
Qualifications for this Role:
Bachelors Degree or equivalent experience
Minimum of four years of experience working in human services with individuals with substance use disorders, co-occurring mental health and substance use disorders and involvement in the criminal justice system.
Extensive knowledge of community treatment, support services and resources
Knowledge of the criminal justice system, court processes and alternative to detention/incarceration services
Valid Driver License required and a driving record that will permit the use of an Agency vehicle to transport clients to appointments or other activities as needed.
Bachelor's Degree required.
Associates accepted with experience.
Bilingual English/Spanish a plus.
Compensation Range: $45,000 - $48,000
Clinical Research Coordinator
Clinical Research Associate Job 24 miles from Elmont
Job Description
Job Title: Clinical Research Coordinator
Department: Site Operations
Reports To: Site Manager
Status: Non-exempt (hourly)
Compensation: $17.00 - $19.00
Position Summary: We are seeking a reliable and experienced Clinical Research Coordinator to join our growing team at Elite Clinical Network. This position will be responsible for collaborating with the Principal Investigator, human subjects, IRB, and pharmaceutical company to ensure smooth, accurate progress of clinical trials from the planning stage through trial completion and post-study closure. Ideal candidates will possess working knowledge of clinical trial procedures.
Essential Duties:
Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
Provides accurate and timely data collection, documentation, entry, and reporting
Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol
Communicates and collaborates specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants
Qualifications:
Bachelor’s degree or certified Medical Assistant
If you are a dedicated and reliable Clinical Research Coordinator, we invite you to apply for this exciting opportunity. Join us and be a key player in shaping the future of our business.
ECN is an equal opportunity employer. We make every effort to make our hiring process accessible to all users. If you need assistance completing the application process, please contact Human Resources via *********************************
Clinical Research Associate
Clinical Research Associate Job 17 miles from Elmont
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
3+ years of clinical research experience
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
Sr. Clinical Research Coordinator TT
Clinical Research Associate Job 12 miles from Elmont
The Clinical Research Coordinator is responsible for coordinating the initiation and activation of all new clinical trial protocols. This role involves developing study tools, reviewing patient charts, confirming protocol eligibility, and maintaining research records. Collaboration with Research Nurse Clinicians and physicians is crucial to ensure informed consent and accurate documentation. Additionally, the role includes grading adverse events, completing serious/unexpected adverse event forms, and liaising with study sponsors.
Responsibilities
* Coordinate the initiation and activation of all new clinical trial protocols.
* Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.
* Develop study tools using Oncore, Excel, and Word, including eligibility checklists, medication diaries, calendars, and flow sheets.
* Review patients' charts and medical history to confirm protocol eligibility and obtain necessary source documents.
* Ensure IRB approved informed consent forms are obtained, signed, and correctly filed.
* Maintain research records for all enrolled patients, including patient consent, eligibility, and corresponding source documents.
* Assist with grading adverse events using NCI common toxicity criteria or protocol-specific grading scales.
* Complete Serious/Unexpected Adverse Event forms as required by study sponsors and institutional guidelines.
* Provide regular reports to tumor study group members and Principal Investigator using Oncore.
* Serve as study liaison with study sponsors, scheduling monitoring visits and conference calls.
Essential Skills
* Minimum of 4 years of clinical research experience.
* Minimum of 4 years of oncology experience.
* Experience working in multiple EDC systems such as Medidata and Inform.
* Experience in data management, responsible for 60% of the role.
* Experience recruiting, screening, and consenting patients for clinical trials.
Additional Skills & Qualifications
* Bachelor's Degree minimum.
* Experience in blood processing.
* Experience from gynecology oncology group or nursing is acceptable.
Work Environment
The position requires on-site presence in the Bronx four times a week.
Pay and Benefits
The pay range for this position is $35.00 - $39.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in bronx,NY.
Application Deadline
This position is anticipated to close on Jun 27, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.