{"id":7403,"date":"2011-10-28T09:39:01","date_gmt":"2011-10-28T13:39:01","guid":{"rendered":"http:\/\/www.bu.edu\/csmet\/?p=7403"},"modified":"2011-10-28T09:41:03","modified_gmt":"2011-10-28T13:41:03","slug":"senior-clinical-trial-associate","status":"publish","type":"post","link":"https:\/\/www.bu.edu\/csmet\/2011\/10\/28\/senior-clinical-trial-associate\/","title":{"rendered":"Senior Clinical Trial Associate"},"content":{"rendered":"<p><strong>Job Description <\/strong><\/p>\n<p><strong>POSITION SUMMARY: <\/strong><\/p>\n<p>Supports the Project Team by assisting in the administrative organization and management of projects ensuring compliance with Premier Research drug and\/or device SOPs, Sponsor and ICH-GCP\/ISO14155 requirements. This position may also involve general office administration tasks. The role involves high utilization of PC-based software packages for word processing, spreadsheets, and graphics. \u00a0Position will be office based.<\/p>\n<p><strong>PRIMARY JOB FUNCTIONS:<\/strong><\/p>\n<ul>\n<li>Manages administrative support and tasks for the Clinical Project Team, including but not limited to filing, faxing, memos, letters, photocopying and first-pass review of T&amp;Es support for designated project team(s), as required<\/li>\n<li>Site management communication for non-protocol related questions<\/li>\n<li>Provides follow-up with Sponsor regarding study related issues as delegated by Project Manager or Clinical Manager<\/li>\n<li>Prepares study documents at the direction and oversight of the Project Manager<\/li>\n<li>Attends project team meetings,<strong> <\/strong>prepares meeting agendas and minutes, and maintains action item lists from meetings<\/li>\n<li>Collects and tracks regulatory documents for submission to Central and\/or Local IRB, Ethics Committees, Competent Authorities and\/or other committees, as appropriate<\/li>\n<li>Verifies IRB\/EC approvals and collects and tracks other required regulatory documents; maintains study enrollment tracking and study status spreadsheets, as appropriate<\/li>\n<li>Distributes study materials to investigator sites, Sponsors and team members, as needed<\/li>\n<li>Prepares documents for and distributes various investigator, regulatory, operations, guidelines and training manuals<\/li>\n<li>Assists in preparation for investigator and project launch meetings<\/li>\n<li>Assists in preparation for and attends client meetings<\/li>\n<li>Supports clinical monitoring staff for visit preparation regarding regulatory document tracking and other study file correspondences<\/li>\n<li>Acts as the central contact for all members of the Clinical Project Team for the transmission, collation, tracking and filing of project documents, including but not limited to: site visit reports, status reports, CRFs, critical \/ regulatory documents, expense reports, financial reports, meeting minutes<\/li>\n<li>Assists the Project Manager in facilitating verbal and written communication between Project Team members<\/li>\n<li>Communicates with investigator sites for non-protocol related questions and possible query\/monitoring related matters as delegated by Project\/Clinical Manager<\/li>\n<li>Creates and maintains Trial Master File according to Premier-Research Group or client SOPs<\/li>\n<li>Where required, organises travel and logistical arrangements for client, investigator and internal meetings and attends as necessary; takes and distributes minutes<\/li>\n<li>Arranges and attends Client and internal teleconferences or meetings; takes and distributes minutes<\/li>\n<li>Assists with production and distribution of client status reports<\/li>\n<li>Creates study documents, project tracking tools and other administrative tools as required by project team<\/li>\n<li>Works with Project Manager to define study-specific process flow<\/li>\n<li>Assists Sponsors, customers, or others with general project information<\/li>\n<li>Gathers, compiles, and reports information relevant to departmental and project needs<\/li>\n<li>Support the project team in liaising with third party vendors<\/li>\n<li>Assist the project team in distribution of mailings, documents and other study materials to sites, IRB\/Ethics Committees, Competent Authorities and others, as appropriate<\/li>\n<li>Distributes necessary study budget \/ contract adjustment information to Project Team<\/li>\n<li>Enters data into project databases and \/ or Excel spreadsheets in accordance with company standards and project specific guidelines<\/li>\n<li>May assists with adverse event reporting, if required<\/li>\n<li>May accompany CRAs on occasional site visits, if required<\/li>\n<li>May conduct Study Close-Out Visits which require only regulatory document reconciliation<\/li>\n<li>Assists CRAs in in-house monitoring activates such as CRF page separation, tracking and onward distribution, if required<\/li>\n<li>Provides training and mentorship to newly hired or junior level Clinical Trial Associate, as requested<\/li>\n<li>Contributes to SOP revisions and\/or generation of related regulatory document management and study file maintenance<\/li>\n<li>Supports the Start Up Manager in the feasibility process and in the submissions to Ethics Committees and Competent Authorities<\/li>\n<\/ul>\n<p><strong>OTHER RESPONSIBILITIES:<\/strong><\/p>\n<ul>\n<li>To update CV and Training records as necessary and make available for client review where appropriate<\/li>\n<li>Remains alert for new business opportunities, network, and provides information to business development staff or manager<\/li>\n<li>Communicates via electronic mail acknowledging and sending correspondence in a professional, timely manner<\/li>\n<li>Responsible for the liaison with the Premier Research Archive, including management of the dispatch and retrieval of all documents to be archived<\/li>\n<li>May be involved in general office logistical activities<\/li>\n<li>May be responsible for line management and development of other CTAs<\/li>\n<li>May support general office finance and administrative management<\/li>\n<li>May assist in ensuring timely payment of invoices, cash flow, tax and social contribution payments<\/li>\n<li>Performs other project related duties as assigned by the Project Manager<\/li>\n<li>Performs other work-related duties as assigned<\/li>\n<\/ul>\n<p><strong> <\/strong><\/p>\n<p><strong>Required Skills <\/strong><\/p>\n<p><strong>ESSENTIAL\/ SKILL\/EXPERIENCE REQUIREMENTS:<\/strong><\/p>\n<ul>\n<li>Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment is essential<\/li>\n<li>Requires strong planning and organisational skills, verbal, written<\/li>\n<li>Well developed communication skills, good at listening and sharing information with others<\/li>\n<li>Ability to act on their own initiative<\/li>\n<li>Collaborative approach to create an effective team and meet deadlines<\/li>\n<li>Quality and detail oriented with high standards<\/li>\n<li>Must be dependable and meet commitments<\/li>\n<li>Applies clear and consistent performance standards and handles problems decisively and objectively<\/li>\n<li>Strong computer skills in Word, Excel, and email are necessary<\/li>\n<li>Fluent verbal and written English language is essential.<\/li>\n<li>School certificate or equivalent required<\/li>\n<li>Bachelors\u2019 degree (BS, BA, or RN equivalent) in a biological- or science-related field preferred<\/li>\n<li>3 years minimum experience in clinical trials required<\/li>\n<li>Some knowledge of FDA Guidance Documents\/EU Directives\/ICH Guidelines\/ISO14155 regulations, drug\/device development, and clinical monitoring procedures<\/li>\n<\/ul>\n<p><strong>Job Location <\/strong><\/p>\n<p>Quincy, MA US<\/p>\n<p><strong>Position Type <\/strong><\/p>\n<p>Full-Time\/Regular<\/p>\n<p><strong>Contact<\/strong><\/p>\n<p>Interested candidates should submit their resume to: <a href=\"mailto:eugene.sidharto@premier-research.com\">eugene.sidharto@premier-research.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Job Description POSITION SUMMARY: Supports the Project Team by assisting in the administrative organization and management of projects ensuring compliance with Premier Research drug and\/or device SOPs, Sponsor and ICH-GCP\/ISO14155 requirements. This position may also involve general office administration tasks. The role involves high utilization of PC-based software packages for word processing, spreadsheets, and graphics. [&hellip;]<\/p>\n","protected":false},"author":2828,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[60],"tags":[],"_links":{"self":[{"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/posts\/7403"}],"collection":[{"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/users\/2828"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/comments?post=7403"}],"version-history":[{"count":3,"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/posts\/7403\/revisions"}],"predecessor-version":[{"id":7406,"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/posts\/7403\/revisions\/7406"}],"wp:attachment":[{"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/media?parent=7403"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/categories?post=7403"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bu.edu\/csmet\/wp-json\/wp\/v2\/tags?post=7403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}