CTC I

Clinical Trial CoordDivision / Dept.: Various Reports to Title: Supv or AboveJob Code: CD451 Job Family: Clin DevJob Level: A1 FLSA Status: NonexemptSummarized Purpose: Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.Essential Functions and Other Job Information: Essential Functions• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads.• Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.• Provides system support (i.e. GoBalto & eTMF).• Supports RBM activities. • Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.• Supports scheduling of client and/or internal meetings.• Reviews and tracks local regulatory documents.• Transmits documents to client and centralized IRB/IEC. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.• Maintains vendor trackers.• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.• Assists with study-specific translation materials and translation QC upon request.Job Complexity Works on assignments that are routine in nature, requiring limited judgment. Has little or no role in decision-making.Job Knowledge Acquires job skills and learns company policies and procedures to complete routine tasks.SupervisionReceivedNormally receives detailed instructions on all work. Works under close supervision.Business RelationshipsContacts are primarily within immediate work unit. Contacts involve obtaining or providing information requiring little explanation or interpretation.Qualifications: Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.Bachelor's degree preferred.Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Ability to work in a team or independently as required• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency• Strong customer focus• Flexibility to reprioritize workload to meet changing project timelines• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all nonclinical/clinical aspects of project implementation, execution and closeout • Good English language and grammar skills and proficient local language skills as needed• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems• Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude and good interpersonal skillsManagement Role:No management responsibilityWorking Conditions and Environment: • Work is performed in an office/laboratory/clinical and/or home office environment with exposure to electrical office equipment. • Occasional drives to site locations. Potential Occasional travel required.Physical Requirements:• Frequently stationary for 4-6 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Occasional mobility required. • Occasional crouching, stooping, bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance.Percent Billable:80% - 100%Created by / last revised by (Manager Name):Naomi Wilson / Mary BarnhillTitle: ED Centers for Clinical Dev/ Dir Clin AdminCompensation Review By: Sarah Hasch Title: Assoc Comp AnalystLast Revision Date: 1/10/2020This document is intended to describe the general nature and level of work being performed by this job. This document is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Individual responsibilities will be defined by your leadership team and will vary based on business needs.