Senior Clinical Trial Operations Specialist - Remote

Senior Clinical Trial Associate - Contract - REMOTE, Princeton, NJ Drive clinical trial excellence from behind the scenes-where precision, coordination, and impact meet. Proclinical is seeking a Senior Clinical Trial Associate to join our client's Clinical Operations in the US. Primary Responsibilities: The successful candidate is an advanced professional who supports planning, execution, and management of clinical trials. Skills & Requirements: Must-Haves: Bachelor's degree in life sciences or healthcare related field 4+ years' experience in a clinical research related position TMF experience Experience coordinating and tracking aspects of contract execution and Purchase Order (PO) generation Desired Skills: Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook Solid understanding of the responsibilities and needs of other functions in a clinical trial Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment Ability to maintain confidentiality of proprietary information A team player that takes initiative Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within organization The Senior Clinical Trial Associate's responsibilities will be: Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF's, monitoring visit reports, etc. Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs Performs quality checks on the study TMF with oversight of study Clinical Operations Lead (COL) Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc. Coordinates and tracks clinical trial equipment and supplies Coordinates and tracks shipments of drug supply Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation May support and participate in departmental/cross-functional process improvement initiatives Supports the trial team to produce and distribute study newsletters Supports collection and updating of clinical trial insurance Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc. Serves as point of contact for 1 or more low to medium complexity vendors with oversight of study Clinical Operations Lead Liaises with clinical trial sites as required May assist in the coordination of Investigator Meetings and potentially present content May assist the study Clinical Operations Lead with timeline maintenance and may lead smaller cross-functional team meetings with oversight of study Clinical Operations Lead May support additional ad-hoc activities as agreed with the study Clinical Operations Lead If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at View email address on click.appcast.io. If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page. Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - #J-18808-Ljbffr