Job details
Salary $35 - $40 an hour job type contract
Full job description
Immediate need! informed consent form specialist opening to support large pharmaceutical client!
100% remote & actively interviewing next week!
Description:
Top skills:
Patient consent forms
Interpret consent form
Excel proficiency
Develop guidelines
Interpretation on the backend
Develop forms for irb approval
Provides administrative and codification services related to project deliverables and management of sensitive consent documentsWorks in conjunction with lab supervisor to ensure successful completion of project-related activitiesPosition will oversee the retrieval of protocol related consent documents, organizing and prioritizing the review and coding of these documentsWorks closely with protocol managers, site managers, regional hub managers and client icf (informed consent form) subject matter expertsCodifies consent language, including review of each irb approved site level icf, assesses consent parameters, updates data in excel tables, documentation of findings and maintaining consent tracking logMaintains metrics and proactive communication with the lab supervisor and icf team to ensure successful project delivery to internal stakeholdersPosition performs a variety of highly responsible administrative and operational support functions of a wide and complex nature.
Essential functions
1Coordinates receiving, organizing and filing of sensitive consent documents from various clinical trials.
2Reviews irb approved icf documents.
3Documents pre-determined standard consent attributes in excel tracker on a per study basis.
4Documents consent reviews in consent tracker on share point.
5Maintains consent study folders with all icfs, and pertinent review information.
6Codes findings from consent reviews into biostore sample management system (transfers data from excel sheets to biostore system).
7Communicates issues, concerns or questions related to icf language to sme team and escalates to legal, as appropriate.
8Supports other customer-specific initiatives related to icf and inventory management, including use of bst systems.
9Keeps an organized work space with independent organization systems.
10Initiates critical thinking in problem solving and decision making as necessary and exercises good judgment in resolving challenges related to completion of a project
Overall, we are looking for someone who has been involved with consent writing/interpreting/negotiating itself (how to interpret the language changes coming from those consents).
Additional skills & qualifications:
Bachelor’s degree in a science related field and at least 1-2 years’ experience in clinical, healthcare, regulatory or pharma environment
Cra/project management experience, preferred
Knowledge of informed consents and process, required
Knowledge of medical or science terminology, preferred
Understanding of good clinical practices (gcp), preferred
Excellent interpersonal, organizational, and oral and written communication skills
Efficient in microsoft office suite, adobe acrobat, and adaptable to available online tools and databases
Spreadsheet capabilities
Strong analytical skills and attention to detail
Professional attitude with a friendly and courteous demeanor
Ability to effectively and efficiently handle multiple, simultaneous, and complex tasks and projects and establish priorities
Information research, analysis, and evaluation skills
Ability to use independent judgment and to manage and impart confidential information
Ability to follow and understand oral and written instructions without immediate supervision
Compensation is tied to the colorado market for jobs performed in coloradoOther locations may be subject to variances based on locations-related factors.
We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employmentBenefits are subject to change and may be subject to specific elections, plan, or program termsThis temporary role may be eligible for the following:
Medical, dental & vision
401(k)/roth
Insurance (basic/supplemental life & ad&d)
Short and long-term disability
Health & dependent care spending accounts (hsa & dcfsa)
Transportation benefits
Employee assistance program
Time off/leave (pto, vacation or sick leave)
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About actalent:
Actalent connects passion with purposeOur scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve moreEvery day, our experts around the globe are making an impactWe’re supporting critical initiatives in engineering and sciences that advance how companies serve the worldActalent promotes consultant care and engagement through experiences that enable continuous developmentOur people are the differenceActalent is an operating company of allegis group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
