Sr. Clinical Study Associate

Sr. Clinical Study Associate

Role Purpose:

The U.S. Medical Affairs Sr. Clinical Study Associate (CSA) is responsible for providing operational support to multiple study teams through all phases of clinical study management (Plan, Start-up, Conduct, and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.

Major Responsibilities and Accountabilities:

Mentoring of junior level Clinical Study Associates

Communicate with internal team members and Contract Research Organizations (CROs) regarding trial start-up, maintenance, and close-out activities.

In collaboration with the Clinical Study Manager (CSM), assists in the oversight of vendor activities along with the CRO.

Oversight/support of some CRO activities, such as:

Receive regulatory documents for review and submission to the Regulatory Department.

                       Develop Trial Master File (TMF) plan and manage through transfer of documents to the

Sponsor

Provides guidance with development of the clinical trial binders for study sites.

                       Manage and track study-specific payments and invoices.

Provide support for Investigator Meeting planning, including organizing meeting materials and provide on-site meeting assistance (as needed).

Oversee CRO tracking systems and tools to support the conduct of a clinical trial from the start-up to close-out phase.

Provides support to CSM on startup activities

Review and collaborate with CSM on the development of certain study specific plans and/or processes (e.g., Satellite Site Management Plans or Drug Destruction Memos). Collaboratively work with CRO to ensure CTMS has current updated information.

Manage and track vendor-specific payments and invoices

Assist with maintaining tracking and reporting of study metrics. Coordinates with Clinical Study Manager (CSM) to communicate relevant trial information between various internal functional members and contract vendors.

              Manage tracking and delivery of clinical/non-clinical supplies.

Generate and review trial management reports from internal tracking systems at requested intervals.

Conduct timely review of clinical trial documents upon request.

Review Informed Consent documents as well as Monitoring Visit Report Review (PSSV, SIV, IMV and COV).

Provide support to both internal and external departmental members when necessary.

 May serve as subject matter expert on task forces, initiatives, and working groups.  Some travel may be required.

Key Capabilities

     Highly effective verbal and written communication skills; effectively delivers key messages;ptitude to independently communicate with teams and stakeholders.

Demonstrates an aptitude to distill information from multiple sources to create meaningful insights and induces collaboration and innovative thinking study-wide.

Experience with effective vendor management preferred.

Demonstrates an aptitude for strategic thinking skills; manages risks (including risk identification and mitigation); identifies critical path / critical dependencies.

Strong customer focus with functional peers, vendors, country affiliates, etc.

Excellent planning and organizational skills.

      Ability to build trusting and collaborative relationships that promote innovation, knowledge-sharing and adaptation to change.

Practices the ability to influence and negotiate to achieve team goals.

Consistently supports change in an effort to continue to develop USMA's dynamic organization.

Demonstrates creativity and innovation to support projects and initiatives.

Strong technical and analytical skills and ability to manage system data maintenance across multiple systems.

Aptitude to interpret outputs from analytical tools to enhance and improve study execution. Self-motivated, achievement-driven and exhibits ability to work with minimal guidance.

Education and Experience:

Bachelor's degree or equivalent.

A minimum of 5 years in clinical research, or health related industry is required.

 

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 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 career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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