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Clinical Trial Documentation Specialist
Fairfield, NJ
Job Description
The 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 Friday
MINIMUM QUALIFICATION REQUIREMENTS
To 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
COMMUNICATION SKILLS
OTHER KNOWLEDGE, SKILLS and ABILITIES
PHYSICAL REQUIREMENTS
On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. This position requires the ability to lift up to 20 pounds. Specific vision requirements including reading of written documents, visual inspection of materials, and use of computer monitor screen and mouse frequently.
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.
Job Type: Full Time Base Hours: 9:00AM - 6:00PM Monday through Friday
MINIMUM QUALIFICATION REQUIREMENTS
To 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.
COMMUNICATION SKILLS
- Must have strong communication and interpersonal skills.
OTHER KNOWLEDGE, SKILLS and ABILITIES
- 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.
PHYSICAL REQUIREMENTS
On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. This position requires the ability to lift up to 20 pounds. Specific vision requirements including reading of written documents, visual inspection of materials, and use of computer monitor screen and mouse frequently.
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.
Job Summary
Company
Start Date
Immediate
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
9:00AM - 6:00PM
Required Education
Associate Degree
Required Experience
4+ years
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