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ABOUT US
Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.
JOB SUMMARY
Responsible for the organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training. This is a Full Time opportunity, Monday-Friday from 8am-5pm.
DUTIES AND RESPONSIBILITIES DESCRIPTION
Collect, prepare, and submit documentation to various sponsors/CROs during study start-up, including:
o Submission documents/approvals
o Protocol amendments with respective signature pages
o Informed consent documents o FDA form 1572 o Lab normal result documents
o financial disclosure forms
o Delegation of authority logs
o Licenses
o Reports
o Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)
Collect, prepare, and submit documentation to institutional review boards for all ongoing and new trials.
Serve as a liaison between the IRB, site, and investigator
Obtain necessary signatures from investigators
Coordinate contracts with third-party vendors Maintain and track current staff credentials (i.e., CV, certifications, etc.)
Act as a resource to other staff members with regulatory questions
Adhere to existing standard operating procedures, perform training on SOPs for the staff, and draft new SOPs when necessary.
Maintain regulatory documents for ongoing trials, and ensure all appropriate regulatory documents are archived at the conclusion of the study.
Assumes other duties and responsibilities as assigned.
The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
EDUCATION/EXPERIENCE/SKILLS
Must be able to effectively communicate verbally and in writing.
Knowledge of “good clinical practices” for clinical research as defined by the Code of Federal Regulations (CFR).
Demonstrated organizational skills to provide regulatory support efficiently and effectively for multiple clinical trials and projects, providing accurate information in a timely manner.
Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.
Knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, etc.
Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.
Must be self-directed and be able to manage multiple projects and responsibilities.
Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.
A critical thinker with strong attention to detail and superb problem-solving abilities.
WORKING CONDITIONS
Indoor, Clinic environment.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
Job Type: Full-time
Benefits:
Schedule:
Education:
Ability to Relocate:
Work Location: In person
Full Time
$82k-105k (estimate)
05/09/2024
09/05/2024
The job skills required for Regulatory Coordinator include Clinical Research, Clinical Trial, Problem Solving, Leadership, Attention to Detail, Communicates Effectively, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Coordinator. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Coordinator. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Coordinator positions, which can be used as a reference in future career path planning. As a Regulatory Coordinator, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Coordinator. You can explore the career advancement for a Regulatory Coordinator below and select your interested title to get hiring information.