Regulatory Coordinator

Cenexelresearch; Gaithersburg, Northern (MD, KY); On-site; USD 37,000 - 41,000; Full time

Benefits offered by this job

Health Insurance

Dental

Vision

LTD

STD

Life Insurance

401k

Job summary

CenExel Clinical Research in Gaithersburg, MD, is seeking a Regulatory Affairs Coordinator to organize and implement regulatory documents for clinical trials in accordance with FDA guidelines and ICH GCP.

You will support start-up activities, maintain training, and liaise with IRBs, sponsors, and investigators as part of a collaborative team focused on quality and timely deliverables.

Qualifications

• 0-2 years of experience in clinical research regulatory affairs.
• Knowledge of good clinical practices (GCP) as defined by CFR.
• Demonstrated organizational skills to support multiple trials and projects with accuracy and timeliness.
• Ability to prioritize workload and coordinate with PI, coordinators, sponsors, and IRBs.

Responsibilities

• Collect, prepare, and submit documentation to sponsors/CROs during study start-up.
• Submit documents to IRBs for ongoing and new trials; act as liaison between IRB, site, and investigator.
• Coordinate contracts with third-party vendors and maintain staff credentials.
• Adhere to SOPs and provide staff training; draft new SOPs when necessary.
• Maintain regulatory documents and archive them after study conclusion.

Skills

Regulatory affairs

FDA CFR knowledge

Organizational skills

Communication skills

PC skills (Excel/Word)

Tools

Excel

Word

Job description

CenExel CBH
9318 Gaither Rd.
Suite 220
Gaithersburg, MD 20877, USA

Description

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.

Compensation: $27-$30/h. depending on education, experience, and skillset.

Essential Responsibilities and Duties:

• Collect, prepare, and submit documentation to various sponsors/CROs during study start-up, including:
• o Protocol amendments with respective signature pages
• o FDA form 1572
• 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:

• 0-2 years of experience in clinical research regulatory affairs.
• 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.
• Must be able to effectively communicate verbally and in writing.

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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.