Study Manager I
4 days ago
Study Manager
A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis.
DUTIES & RESPONSIBILITIES
- Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis.
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
- Adherence and compliance to the assigned protocols at their respective site(s).
- Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to
- Sponsor-provided and IRB-approved Protocol Training
- All relevant Protocol Amendments Training
- Any study-specific Manuals Training as applicable
- Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
- Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s).
- Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s).
- Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s)
- Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner.
- Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner.
- Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation.
- Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines.
- Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s).
- Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial.
- Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents.
- Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site.
- Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned.
- Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s).
- Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s).
- Being prepared for and available at all required company meetings.
- Submitting required administrative paperwork per company timelines.
- Occasionally attending out-of-town Investigator Meetings.
- Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
- Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
- Facilitate effective communication between patients, healthcare providers, and research staff
- Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives
- Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent
- Facilitate effective communication between patients, healthcare providers, and research staff
- Any other matters as assigned by management.
KNOWLEDGE & EXPERIENCE
Education:
- High School Diploma or equivalent required
- Bachelor's degree preferred
- Foreign Medical Graduates preferred
Experience:
- Minimum of 5 years experience in Clinical Research
- Supervisory experience preferred
- Wide therapeutic range of clinical trials experience preferred
- Regulatory research experience is a plus
- Bilingual in Spanish Required
Credentials:
- ACRP or equivalent certification is preferred
Knowledge and Skills:
- Goals-driven while continuously maintaining quality.
- Must be detailed-oriented, proactive, and able to take initiative.
- Must have strong written and communication skills.
- Must have excellent customer service skills.
- Proficient communication and comprehension skills both verbal and written in the English language are required.
- Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written required
Powered by JazzHR
rM4B0409Ls
-
Work Study
2 months ago
New York City, United States The New School Full timeFederal Work Study Student Employee Graduate Assistant I/ Lit Studies (Writ. Lit Blog)Federal Work Study/ Graduate Assistant I/ Lang. Eugene Lang College is hiring a Graduate Student to provide departmental support for the Literary Studies program Assistant, Graduate, Social Media, Faculty, Education
-
Jersey City, New Jersey, United States i-Health Full timeThe Clinical Care Coordinator performs a variety of patient care and administrative responsibilities to support patients and providers. Attention to detail, surgery scheduling and answering patient calls with great customer service and compassion is a must. Casting and Splinting, hand and upper extremity experience is a plus.Full time role, Monday - Friday...
-
Jersey City, New Jersey, United States i-Health Full timeThe Phlebotomist performs basic laboratory functions: specimen collection (i.e. venipuncture, capillary, cultures, and chain of custody) & processing of specimens. They will focus on providing comprehensive care both in the lab and in the clinic and will be the primary contact for their location in-house Lab while being available to assist clinical teams...
-
Intensive Case Manager, Home Study
1 month ago
Jersey City, United States Church World Service Full timeOverview Reports to:HSPRS SupervisorLocation/ Work Arrangement:Jersey City, NJSalary Minimum:$60,800 Salary Maximum:$76,000 About CWS Founded in 1946, Church World Service (CWS) is a non-profit and faith-based global humanitarian organization that provides sustainable self-help, development, disaster relief, and refugee and immigrant...
-
Intensive Case Manager, Home Study
3 weeks ago
Jersey City, United States Church World Service Full timeOverview Reports to:HSPRS SupervisorLocation/ Work Arrangement:Jersey City, NJSalary Minimum:$60,800 Salary Maximum:$76,000 About CWS Founded in 1946, Church World Service (CWS) is a non-profit and faith-based global humanitarian organization that provides sustainable self-help, development, disaster relief, and refugee and immigrant...
-
Delivery Driver Needed
3 weeks ago
Jersey City, United States I Food Full time**About us** I Food is a small business in Jersey City, NJ. We are professional, agile and our goal is to i food member. Our work environment includes: - Modern office setting - Food provided ''' **Duties**: - Safely and efficiently operate a delivery vehicle to transport goods to customers - Follow assigned routes and schedules to ensure timely...
-
Infusion Nurse, RN Rheumatology
3 weeks ago
Jersey City, New Jersey, United States i-Health Full timeThe Infusion Nurse will be responsible for delivering care and an excellent patient experience for Rheumatology patients. The Infusion Nurse will perform assessments, provide evaluation and create a plan of care in coordination with the Rheumatologists. Other duties will include infusion therapy, triage, clinical care coordination with the healthcare...
-
Software Engineer
4 days ago
Jersey City, United States Study International Full timeABOUT FANDUEL FanDuel Group ("FanDuel") is an innovative sports-tech entertainment company that is changing the way consumers engage with their favorite sports, teams, and leagues. The premier gaming destination in the United States, FanDuel consists of a portfolio of leading brands across gaming, sports betting, daily fantasy sports, advance-deposit...
-
Open Pool
4 weeks ago
Jersey City, United States InsideHigherEd Full timePosition DescriptionHudson County Community College (HCCC) is an award-winning, comprehensive, urban community college serving one of the most historic and ethnically diverse areas of the United States! The diversity and the multitude of our community’s cultures, life experiences, skills, and aspirations are the very values and traits that empower us to be...
-
Senior Clinical Data Manager
4 weeks ago
Jersey City, United States Eikon Therapeutics, Inc. Full timeEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...
-
GLP Study Director
7 days ago
Culver City, United States BayOne Solutions Full timeGLP Study DirectorDuration: 03 Months Contract to perm with possible extensionWork Location – Pleasanton, CA.Pay: $28/hr.- $32/hr. on W2.Job Description:GLP Lab MaintenanceMaintain lab documentation following Standard Operating Procedures (SOP’s) to ensure GLP complianceMaintain and calibrate lab equipment at required intervals to ensure GLP...
-
Study Coordinator
3 weeks ago
West Valley City, United States University of Utah Full timeOur research team led by Dr. Yelena Wu at Huntsman Cancer Institute is hiring a full-time Study Coordinator to join our highly collaborative and energetic group. The Study Coordinator will work on various research projects focused on skin cancer prev Coordinator, Research, Management, Education, Cancer, Training
-
Site Manager
4 days ago
Jersey City, United States DM Clinical Research Full timeJob DescriptionJob DescriptionSite ManagerThe Site Manager's job is to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. Also To ensure study enrollment meets or exceeds Sponsors' expectations...
-
Vice President, Service Management I
2 weeks ago
Jersey City, New Jersey, United States BNY Mellon Full timeTechnology Services Group, Inc. seeks a Vice President, Service Management I in Jersey City, NJ, to be responsible for supporting senior analysts and process leads in development, implementation, mentoring of, and maintenance of IT service management (ITSM) processes. ITSM is to manage process of end-to-end delivery of IT services to customers. This includes...
-
Vice President, Service Management I
2 weeks ago
Jersey City, New Jersey, United States The Bank of New York Mellon Full timeTechnology Services Group, Inc. seeks a Vice President, Service Management I in Jersey City, NJ, to be responsible for supporting senior analysts and process leads in development, implementation, mentoring of, and maintenance of IT service management (ITSM) processes. ITSM is to manage process of end-to-end delivery of IT services to customers. This includes...
-
Project Manager
1 month ago
Cooper City, United States AT&I Systems Full timeJob DescriptionJob DescriptionPosition Summary:AT&I is looking for a full-time, enthusiastic, results-driven, and forward-thinking Project Manager to join our amazing culture. In this role, you will be responsible for the installation, programming, system start-up/check-out, certification, and related customer training on assigned projects. Works with...
-
Architect I
3 weeks ago
Kansas City, United States Crawford Architects, LLC Full timeJob DescriptionJob DescriptionCrawford Architects is seeking an Architect I to join our growing Kansas City office. We promote a creative and collaborative team culture as we strive toward innovation and excellence in our unique practice. In this role, you will assist in the overall efforts of various project phases, including architectural design,...
-
Designer I
2 weeks ago
Kansas City, Missouri, United States Crawford Architects, LLC Full timeCrawford Architects is seeking a Designer I to join our growing Kansas City office. We promote a creative and collaborative team culture as we strive toward innovation and excellence in our unique practice. In this role, you will assist in the overall efforts of various project phases, including architectural design, documentation, and construction...
-
Architect I
7 days ago
Kansas City, United States Crawford Architects, LLC Full timeJob DescriptionJob DescriptionCrawford Architects is seeking an Architect I to join our growing Kansas City office. We promote a creative and collaborative team culture as we strive toward innovation and excellence in our unique practice. In this role, you will assist in the overall efforts of various project phases, including architectural design,...
-
Designer I
3 weeks ago
Kansas City, United States Crawford Architects, LLC Full timeCrawford Architects is seeking a Designer I to join our growing Kansas City office. We promote a creative and collaborative team culture as we strive toward innovation and excellence in our unique practice. In this role, you will assist in the overall efforts of various project phases, including architectural design, documentation, and construction...