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13 days old

Clinical Trial Disclosure

Kelly Services
North Chicago, IL 60064
**Clinical Trial Disclosure - North Chicago, IL**



**Contract Length: 12 months W2 onsite only**



**Rate: $50.00 to $53.50/hour**



**Hours:** **8:30 to 5pm**




+ The medical writing required for this role would be considered light. Candidate would typically have written content available to assist with writing content for public websites. Experience with oncology and neuroscience therapeutic areas a plus.

+ Writers with experience in writing Oncology regulatory documents (protocols, clinical study reports) with less turnover.

+ Experience: 2+ years of clinical research experience, Bachelors degree preferably in a health or science related field.

+ Nice to have: Authored any publications or experience with clinical study protocol writing. Clinical study reports and consumer education material



**Top 5 skills:**



a. Required Skill 1: Ability to take clinical study protocols and distill them down to simple content for public websites.

b. Required Skill 2: Ability to handle multiple (5-10) assignments at one time, project manage their own work.

c. Required Skill 3: Strong oral and written communication skills. Ability to influence and align stakeholders.

d. Required Skill 4: Proven track record for meeting deadlines in a highly regulated environment.

e. Required Skill 5: Excellent attention to detail.

Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

Assists the Clinical Trial Disclosure (CTD) area with the execution of AbbVie clinical drug trial registration (primarily) and results disclosure postings per the applicable regulatory and Standard Operating Procedure (SOP) requirements.


Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

Works closely with/supports the Senior Associate, CTD and Manager(s) of CTD: to determine the AbbVie drug trials required to be registered and results disclosed, to effectively communicate this information and related timelines to the applicable individuals involved in these activities, to provide guidance to and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate and complete information.

Works closely with/support the Senior Associate, CTD and Manager(s) of CTD in operationalizing changes in both the US and International regulatory environment via participation in the development and implementation of SOPs/processes as well as creates efficiency improvements/furthers system automation and related communication and training activities.

Participates in CTD compliance prevention by providing QC checks and metrics as requested.

Maintains/tracks CTD for AbbVie clinical drug trials, including the documentation and storage of the information.

Cross-trains with other CTD staff.

Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.

Accountable to Senior Manager, CTD. Act as a key contributor, who exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.

Daily interaction with Senior Associate, CTD and/or Manager(s) of CTD as well as significant interface/communication with cross-functional areas.

Expedient escalation of issues to management is essential and may have a direct impact on CTD compliance.

.


Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

Bachelor's degree (BA/BS) from an accredited college or university is required, preferably in a health or biological science field.

Must have 2+ years of clinical research experience or experience in a related area such as quality or regulatory and working knowledge of drug development.

Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).

Must have the ability to prioritize roles and responsibilities daily and work well under deadline pressure in a team environment in order to execute goals to ensure they are achieved (i.e. maximizes individual skills utilizing the collective skills of the CTD area).





**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.



**Also, feel free to follow up via email to RACS113@KELLYSERVICES.COM**






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-08 Expires: 2019-12-09

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Clinical Trial Disclosure

Kelly Services
North Chicago, IL 60064

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