2 Regulatory Coord I Jobs in Decatur, GA
SORT BY
C
C
Regulatory Coord I
$80k-103k (estimate)
Full Time | Scientific Services
1 Week Ago
CenExel is Hiring a Regulatory Coord I Near Decatur, GA
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.
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 Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$80k-103k (estimate)
POST DATE
05/08/2024
EXPIRATION DATE
07/06/2024
WEBSITE
cenexelresearch.com
HEADQUARTERS
SALT LAKE CITY, UT
SIZE
25 - 50
FOUNDED
1980
CEO
RYAN M BROOKS
REVENUE
<$5M
INDUSTRY
Scientific Services
Related Companies
About CenExel
The Atlanta Center for Medical Research specializes in the advancement of treatment of illnesses in the central nervous system and in other therapeutic areas. ACMR is a 24-hour privately owned 150,000 square foot research facility with a secured, 300-bed inpatient unit. Conducting both outpatient and inpatient clinical trials, our expertise and experience are in Phases 0/I first in humans through IV of industry sponsored pharmaceutical trials. Over the past 30 years, ACMR has assisted in the advancement of critical scientific milestones, helping sponsors bring important medications to the publ...ic.
More
Show less
Show more
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
