Site Management Associate II (Remote)

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-size: 11.0pt;"><strong>Job Description</strong>:</span></p><ul><li><span style="font-size: 11.0pt;">Work from home in a fully remote capacity </span></li><li><span style="font-size: 11.0pt;">Provide support for projects according to Covance Standard Operating Procedures (SOPs), Project-specific Controlled Documents, FDA and ICH Guidelines and GCPs </span></li><li><span style="font-size: 11.0pt;">Perform investigative site recruitment/feasibility, essential document collection and review </span></li><li><span style="font-size: 11.0pt;">Provide in-house site management</span></li><li><span style="font-size: 11.0pt;">Develop and/or maintain tracking systems for projects</span></li><li><span style="font-size: 11.0pt;">Conduct centralized monitoring responsibilities when necessary as assigned by supervisor</span></li><li><span style="font-size: 11.0pt;">Review study data in accordance with Data Management Plans and other applicable plans </span></li></ul><p style="margin-bottom: 6.0pt;"> </p><p style="margin-bottom: 6.0pt;"><strong><span style="font-size: 11.0pt;">Duties and Responsibilities</span></strong><span style="font-size: 11.0pt;">:</span></p><ul style="margin-top: 0in;"><li style="margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Ensure compliance with Covance SOPs, Project-specific Controlled Documents, FDA and ICH guidelines GPPs, and GCPs for clinical conduct in all aspects of daily work including adherence to Project Plans, Data Management Plans, Site Management Plan, Monitoring Conventions, etc. </span></li><li style="margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Perform site evaluation and recruitment including, collection and review and close out of required critical documents from sites (including submissions and notifications to Institutional Review Boards or Ethics Committees (where applicable))  by c<span style="color: black;">reating, updating, tracking, and maintaining study-specific trial management files, tools, and systems</span></span></li><li style="margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Support investigators in fulfilling their obligations with regard to submission according to applicable local, regulatory, and IRB/IEC requirements</span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Oversee and conduct training with sites on web-based applications; including but not limited to:  Web-ex and Investigator Meetings</span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Independently manage study sites to ensure adherence to the study design </span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Maintain regular contact with study sites via telephone (in-coming and out-going calls), fax, email, and newsletters </span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Maintain timely documentation of site contacts in defined project system</span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Act as primary point of contact for assigned study sites and retains primary responsibility for the resolution of all site issues </span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Independently manage subject screening/enrollment, Data Collection Tool retrieval, study supply, and query distribution to/retrieval from assigned study sites</span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Assist in development of phone scripts, questionnaires, study site materials and other project specific tools</span></li><li style="margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Facilitate the preparation of status reports, payments to sites and participation in regular project team meetings including review and distribution of meeting minutes</span></li><li style="color: black; margin-top: 6.0pt;"><span style="font-size: 11.0pt; color: windowtext;">Oversee and maintain communications with vendors and facilitate the management of study supplies </span></li><li style="color: black; margin-top: 6.0pt;"><span style="font-size: 11.0pt;">Manage investigator site budgets</span></li></ul><ul><li style="margin: 6.0pt 0in 6.0pt .5in;"><span style="font-size: 11.0pt;">Independently Review study data in accordance with </span><span style="font-size: 11.0pt;">Monitoring Plan, Site Management Plan, </span><span style="font-size: 11.0pt;">Data Management Plans and applicable (SOPs, etc) to identify data trends, data inconsistencies, and erroneous, missing, incomplete, or implausible data through the aggregate review of study data by patient, site, and/or project</span></li></ul><ul style="margin-top: 0in;"><li style="margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Ensure accurate and expeditious safety reporting in accordance to federal guidelines and sponsor and program requirements</span></li><li style="margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Support mentoring of junior staff members</span></li></ul><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">General Monitoring Responsibilities – Centralized:</span></li><li style="margin: 0in 0in 6.0pt .75in;"><span style="font-size: 11.0pt; color: black;">Initiate, monitor and close out Investigator sites via phone including review of Case Report Forms </span></li><li style="margin-left: .75in;"><span style="font-size: 11.0pt;">Review site information and communicate with sites to resolve data discrepancies </span></li></ul><ul style="margin-top: 0in;"><li style="margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Perform other duties as assigned by management</span></li></ul><p style="margin-bottom: 6.0pt;"><strong><span style="font-size: 11.0pt;">Travel Requirements:        </span></strong></p><ul style="margin-top: 0in;"><li style="color: black; margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Available for travel up to 20% of the time, including overnight stays as necessary, consistent with project needs and office location</span></li><li style="margin-bottom: 6.0pt;"><span style="font-size: 11.0pt;">Ability to drive and have a valid driver’s license</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 11.0pt;">University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)</span></li><li><span style="font-size: 11.0pt;">In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered</span></li><li><span style="font-size: 11.0pt;">Basic understanding of ICH Guidelines and GCP including a basic understanding of regulatory requirements</span></li><li><span style="font-size: 11.0pt;">Good understanding of the clinical trial process</span></li><li><span style="font-size: 11.0pt;">Fluent in local office language and in English, both written and verbal</span></li></ul><h2>Experience:</h2><h2 style="margin-bottom: 6.0pt;"><span style="font-size: 10pt;">Required:</span></h2><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Minimum of two (2) years clinical research experience of centralized and/or on-site monitoring </span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow up SAEs</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Good planning, organization and problem solving abilities</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Ability to work with minimal supervision</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Good communication and interpersonal skills</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Good analytical and negotiation skills</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Computer competency</span></li><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">Works efficiently and effectively in a matrix environment</span></li><li style="margin: 0in 0in 6.0pt .5in;"><span style="font-size: 11.0pt;">Ability to work within a project team</span></li></ul><h2 style="margin-bottom: 6.0pt;"><span style="font-size: 10pt;">Preferred:   </span>   </h2><ul><li style="margin-left: .5in;"><span style="font-size: 11.0pt;">One (1) or more additional years of experience on site monitoring </span></li></ul>