Job thumbnail

Clinical Trial Manager

Aerotek

10/15/2020

Posting ID: 7338667

Full Time
Share:Facebook iconTwitter iconLinkedin icon

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
* With support of Associate Director, manage clinical site interactions (including assistance with IRB/EC
applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests,
issue resolution, etc.)
* Manage trial start-up, conduct, and close-out activities according to industry and corporate standards with
Director support
* Assist with preparation of key clinical documents (e.g. protocols, informed consent, amendments, CRF's,
training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports,
annual reports, etc.)
* Establish professional rapport and engage in frequent communication with investigational site personnel in
order to keep study on-track
* Track internal metrics, timelines and budgets
* Communicate trial status to trial team
* Prepare and present trial specific updates to Director, Program Managers and Senior Management
* Participate in monitoring activities at clinical trial sites to assure adherence to GCP and ICH guidelines,
regulatory requirements, SOPs, protocols and ensure that data is complete and accurate
* In conjunction with data management personnel, gain understanding of planning, monitoring, and executing
data analyses
* Support applications and technical files as needed
* Collaborate with project specific committees (e.g., DSMB, CEC)
* Assist with preparation for investigators' meetings
* Work with vendors as needed
* Travel up to 25% of the time
* Perform other tasks and duties as required
REQUIREMENTS:
* 5+ years experience as Research Associate, Clinical Trail Assistant, Clinical Trial Coordinator, CRA or
equivalent combination of education and experience
* Experience coordinating external and internal documentation for clinical trials
* Experience interacting with sites, monitors, IRB's, sponsors, vendors, clinical centers, and FDA
* Experience screening and recruiting patients for studies
* Knowledge of adverse event investigation, analysis and reporting procedures and standards
* Proficiency with electronic data management systems
* Familiarity with clinical budget planning and management
* Basic understanding of data collection methodologies
* Familiarity with GCP, ICH, ISO and FDA regulatory requirements
* Experience in coordinating multi-center global clinical trials
* Ability to build collaborative relationships both internally and externally
* Willing to be held accountable for deliverables
* Must be highly organized and detail oriented
* Proven ability to handle multiple projects and changing priorities
* Must be results-driven and exhibit a sense of urgency
* Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant
information
* Strong initiative and positive attitude
EDUCATION:
* BA/BS in Science, Life Sciences or relevant field; or equivalent combination of education and experience




About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.

Contact Information

Recruiter: Amanda Purvis

Phone: (973) 829-4446

Email: apurvis@aerotek.com

Related Courses

Browse All

Blog