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18 days old

Clinical Trials Management Associate

Kelly Services
Foster City, CA 94404
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Clinical Trials Management Associate** at a prestigious Fortune 500 company working in **Foster City.**





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: Clinical Trials Management Associate**





**Pay: $50 per hour**





**Duties**



Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.



With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.



Assures site compliance with the routine protocol and regulatory requirements and quality of data.



Assists in the setting and updating of study timelines.



Assists in CRO or vendor selection.



With guidance from supervisor coordinates CROs or vendors.



Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.



Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.



Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.



May participate in abstract presentations, oral presentations and manuscript development. Interfaces with individuals in other functional areas to address routine study issues.



May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.



Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.



Travel is required.



Excellent verbal, written, interpersonal and presentation skills are required.



Working knowledge and experience with Word, PowerPoint and Excel.



Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.



Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.



Ability to develop tools and processes that increase measured efficiencies of the project.



Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. Must have a general understanding of functional issues and routine project goals from an organizational perspective.





CTMA Job Responsibilities

Must be familiar with routine medical/scientific terminology

Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports

May contribute to SOP development

Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs

May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required

May resolve routine monitoring issues

Must be familiar with good documentation practices and electronic trial master file system

Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures

Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams

Must be able to anticipate obstacles and proactively develop solutions to achieve project goals

Must have a general understanding of functional issues and routine project goals from an organizational perspective

May participate in abstract presentations, oral presentations and manuscript development.

Interfaces with individuals in other functional areas to address routine study issues

Ability to develop tools and processes that increase measured efficiencies of the project

May be asked to assist in the training of CTMAs and CPAs

Assists in CRO or vendor selection

Coordinates CROs or vendors

Assists in the setting and updating of study timelines

May participate in departmental or interdepartmental strategic initiatives under general supervision

Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies

May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required

Assures site compliance with the protocol and regulatory requirements

Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans

Excellent verbal, written, interpersonal and presentation skills are required

Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies

Working knowledge and experience with Word, PowerPoint and Excel


Minimum Expectations/Requirements

At least 3+ years of experience in Clinical Operations and a degree in a relevant scientific/medical discipline (e.g., BA, BS, RN)



? Candidates must have prior experience with clinical ops



? Vendor Mgmt experience



? Troubleshoot issues with vendors/Site Mgmt.



? Ability to plan, execute, and have an understanding of PM



? Bachelors Degree required



CRO Experience is fine as long as managed vendors







**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**










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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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

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Posted: 2020-07-17 Expires: 2020-08-20

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Clinical Trials Management Associate

Kelly Services
Foster City, CA 94404

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