Clinical Research Manager jobs in Bayonne, NJ
Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Recently Added Clinical Research Manager jobs
Clinical Research Coordinator III
- DM Clinical Research
-
Jersey, NJ
FULL_TIME
-
Clinical Research Coordinator III
A CRC III will 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. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure 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 Certification on a timely basis.
- 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.
- Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner.
- Adherence to ALCOA-C Standards with all the relevant clinical trial documentation.
- Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations.
- Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
- Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols.
- Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols.
- Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s)
- Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s).
- Ability to train and mentor site staff, as needed
- Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s)
- Demonstration of appropriate and timely follow-up on the action items, at their respective sites.
- Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s).
- Maintaining a working knowledge of Study Participants’ Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team.
- Maintaining a 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)
- Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines.
- Striving to meet Sponsor subject enrollment goals for their assigned protocols at 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
- Any other matters as assigned by management
KNOWLEDGE & EXPERIENCE
Education:- High School Diploma or equivalent required
- Bachelor's degree preferred
- Foreign Medical Graduates preferred
- 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
- ACRP or equivalent certification is preferred
- 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 are preferred.
- Just Posted
Clinical Research Manager
- Tekskills Inc
-
East Hanover, NJ
CONTRACTOR
- Job Title : Clinical Research Manager Location : East Hanover, NJ ( Hybrid ) Duration : 12 Months Must have : Pharma background is must, clinical research experience, drug development experience, GCP ...
- 21 Days Ago
CRC III
- DM Clinical Research
-
Jersey, NJ
FULL_TIME
- Clinical Research Coordinator III The Clinical Research Coordinator III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regu...
- 1 Month Ago
Clinical Research Nurse
- Kessler Foundation
-
Orange, NJ
FULL_TIME
- Location: West Orange, NJKessler Foundation is seeking a nurse to facilitate clinical research in spinal cord injury (SCI) for the Tim and Caroline Reynolds Center for Spinal Stimulation and to work c...
- 12 Days Ago
Travel Clinical Research Coordinator
- Care Access
-
Newark, NJ
FULL_TIME
- What We Do Care 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 physici...
- 27 Days Ago
Jr. Clinical Research Coordinator
- SGS
-
Union, NJ
FULL_TIME
- Company DescriptionWe are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 97,000 emplo...
- 1 Month Ago
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0 Clinical Research Manager jobs found in Bayonne, NJ area
Director of Distribution - Full-time, Day
- Hiring Now!
-
Jersey City, NJ
- General Summary of Duties: The Site Supply Chain Director (SSCD) is responsible for all supply chain operations within t...
- 4/23/2024 12:00:00 AM
Director of Distribution - Full-time, Day
- Hiring Now!
-
Newark, NJ
- General Summary of Duties: The Site Supply Chain Director (SSCD) is responsible for all supply chain operations within t...
- 4/23/2024 12:00:00 AM
Director of Distribution - Full-time, Day
- Hiring Now!
-
Livingston, NJ
- General Summary of Duties: The Site Supply Chain Director (SSCD) is responsible for all supply chain operations within t...
- 4/23/2024 12:00:00 AM
Clinical Research Finance Analyst.
- NYU Langone Health
-
New York, NY
- NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of...
- 4/22/2024 12:00:00 AM
Senior Clinical Research Program Manager- Oncology
- Northwell Health
-
New York, NY
- Job Description Job Description Provides management of research administration at a clinical site(s) including monitorin...
- 4/22/2024 12:00:00 AM
Clinical Research Finance Analyst. (1126460_RR00089956)
- NYU Langone Medical Center
-
New York, NY
- NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of...
- 4/22/2024 12:00:00 AM
Senior Clinical Research Program Manager
- Northwell Health
-
New Hyde Park, NY
- Job Description Job Description Provides management of research administration at a clinical site(s) including monitorin...
- 4/21/2024 12:00:00 AM
Clinical Research Manager
- Colgate-Palmolive
-
Piscataway, NJ
- No Relocation Assistance Offered # 159181 - Piscataway, New Jersey, United States **Who We Are** Colgate-Palmolive Compa...
- 4/20/2024 12:00:00 AM
About Bayonne, New Jersey
Bayonne /beɪˈjoʊn/ bay-OWN is a city in Hudson County, New Jersey, United States. Located in the Gateway Region, Bayonne is situated on a peninsula located between Newark Bay to the west, the Kill Van Kull to the south, and New York Bay to the east. As of the 2010 United States Census, the city's population was 63,024, reflecting an increase of 1,182 (+1.9%) from the 61,842 counted in the 2000 Census, which had in turn increased by 398 (+0.6%) from the 61,444 counted in the 1990 Census.[21]
Bayonne was originally formed as a township on April 1, 1861, from portions of Bergen Township. Bayonne ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$112,132 to $148,567
Bayonne, New Jersey area prices
were up 1.6% from a year ago
were up 1.6% from a year ago
What does a Clinical Research Manager do?
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Generally, employers are looking for Clinical Research Managers who have a Bachelors degree.
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