Organization : FHI 360
Type : Nonprofits / องค์กรไม่แสวงหาผลกำไร
Date : 6 Nov 2014
View : 693
Deadline : / /
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in Health, Education, Nutrition, Environment, Economic Development, Civil Society, Gender, Youth, Research and Technology; creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories. We are currently seeking qualified candidates for the position of: Clinical Trials Associate
The Clinical Trial Associate (CTA) assists both the project management and clinical operations teams in the implementation a clinical trial. Responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Trial Master File, ensuring that project-specific administrative documents (e.g., contact lists, etc.) are maintained, and ensures sites are supplied with all required materials and supplies. This position has frequent contact with internal and investigator site personnel. CTA could be responsible for managing individual, large, or complex studies / programs. The CTA assists the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support. The CTA supports clinical teams by performing tasks related to study management from start up to study completion. This position is a key role in supporting project team needs. Utilizes technology effectively to support clinical development processes; develops mastery of relevant systems (e.g. study management tools) and identifies new innovative ideas and shares best practices.
Provides administrative support to the project team.
Assists the clinical project management team with written and verbal communications with study staff and sites.
Assists the clinical project management team with the creation of study specific documents and materials, and with the acquisition of study supplies.
Provides study materials and supplies to the study sites and Clinical Research Associate (CRAs).
Prepares and issues meeting minutes, including action items, under the direction of project management.
Maintains the study-specific Trial Master File and associated electronic archives.
Assists the clinical project management team with the organization of meetings.
Support the clinical operations teams with ongoing conduct of studies.
Assists in the closeout of projects by performing a final Quality Control (QC) of the Trial Master File (TMF), identifying items and issues for review and/or follow-up by the CRAs and/or project management.
Assist in the production of slides, overheads, etc. as needed for department, project, and sponsor and or business development.
Travel Requirements: Less than 10%
Typical Physical Demands:
Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Technology to be used: Personal Computer, Microsoft Office (i.e. Word, Excel,
PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.
-Or an equivalent combination of relevant education and/or experience sufficient to successfully perform the key responsibilities of the job.
Applied Knowledge & Skills:
Needs a basic understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.
Ability to write clearly and succinctly; must be able to accurately record meeting minutes and action items.
Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
Ability to prioritize and manage multiple tasks.
Demonstrated effective organizational skills.
Demonstrated strong attention to detail.
Problem Solving & Impact:
Works on problems of limited scope that require a review of various factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Decisions generally affect own job or specific functional area.
Receives general instructions on routine work, detailed instructions on new projects or assignments.
Reports to a Manager.
Does not have direct supervision responsibilities.
Written Communication; Technical skills and learning; Problem Solving; Personal learning and development; Initiative; Ethics and Values; Commitment and Accountability; Ambition and Passion
High School/GED Diploma or its International Equivalent - Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.
0 - 3 years’ experience in clinical research, other research or health care related field. Familiar with applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Proficiency in Microsoft Office, spreadsheet software and other technology required.
Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
Must be able to read, write and speak fluent English.
Bachelor’s degree or its international equivalent preferred.
Related prior work experience preferred.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
We offer competitive compensation and an outstanding benefit package. Interested candidates, please register online through FHI 360’s Career Center at http://www.fhi360.org/careers
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, national or ethnic origin, age, disability or status as a veteran with respect to policies, programs, or activities.