1 Clinical Trial Documentation Specialist Job in Fairfield, NJ
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Clinical Trial Documentation Specialist
$68k-84k (estimate)
Full Time
10 Months Ago
Consumer Product Testing Company is Hiring a Clinical Trial Documentation Specialist Near Fairfield, NJ
Job DescriptionThe Clinical Trial Documentation Specialist position is based within our Clinical Operations group, and works with departmental management and the Principal Investigator in the implementation of project clinical trial protocols.
Job Type: Full Time. Base Hours: 9:00AM - 6:00PM Monday through FridayMinimum Qualification RequirementsTo perform this job, an individual must be able to perform each essential duty satisfactorily and meet the educational and experience requirements.
Essential Duties And Responsibilities
All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.
Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.
Job Type: Full Time. Base Hours: 9:00AM - 6:00PM Monday through FridayMinimum Qualification RequirementsTo perform this job, an individual must be able to perform each essential duty satisfactorily and meet the educational and experience requirements.
Essential Duties And Responsibilities
- Draft and finalize clinical trial protocols under the guidance of the Clinical Division Management, including coordination of protocol revisions and finalization of timelines with Sponsors.
- Prepare documentation for non-IRB trials, and IRB submission, including protocols, Informed Consent Forms, Medical History Forms, letters and other documentation as necessary.
- Schedule clinical studies, including establishment of timeline(s), coordination of pre-study meetings/activities and staffing requirements. Assignment of consulting Physicians on appropriate studies.
- Serve as backup to the Clinical Documentation Specialist and Protocol Coordinator, and assist Clinical Study Coordinators, if necessary, in conducting clinical trials.
- Communicate with study sponsors for use instructions, questionnaires and any other information necessary to implement the clinical trial documentation.
- Peer reviews studies as required for exactness, completeness and accuracy in reporting and protocol compliance
- AAS in Science Discipline, RN, Licensed Cosmetologist, or equivalent
- Four (4) years in science, medical/health, cosmetology or related field.
- Must have strong communication and interpersonal skills.
- Must have initiative and problem solving / analytical skills and keen attention to detail
- Must be organized, flexible, and able to work independently.
- Applicant should possess the ability to organize and maintain all clinical trial information for assigned projects and ensure adherence to established policies and procedures.
- Must have proficient computer skills in the following: Windows Word, Excel and PDF formatting.
- Must have the ability to work collaboratively and effectively with other clinical team members and physicians.
All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.
Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.
Job Summary
JOB TYPE
Full Time
SALARY
$68k-84k (estimate)
POST DATE
08/03/2023
EXPIRATION DATE
08/02/2024
WEBSITE
cptclabs.com
HEADQUARTERS
Fairfield, NJ
SIZE
200 - 500
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