The Senior Clinical Research Specialist will be responsible for managing and monitoring multiple multi-center, randomized controlled clinical studies in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements, preferably including (but not required) 21CFR Part 1271/ 361 Human cells, Tissues, and Cellular and Tissue-Based Products (HCT/P).
This position will be responsible for managing clinical studies from protocol concept through the clinical study report and publication, while ensuring the completion of study deliverables. S/he will have a proven ability to independently prioritize and manage multiple tasks and projects with competing priorities and deadlines, screen and prioritize communications and opportunities from external sources. S/he shall have and utilize technical knowledge and build clinical research capabilities, implementing appropriate procedures and policies. This ideal candidate will be dynamic, articulate, high-energy, organized, and able to support cross-functional coordination in a fast-paced environment. Position is in-house; may entail approximately 25% travel depending on project needs.
•Oversight and management of study-start up activities in multiple multi-center RCTs, as needed
•Performs Qualification (as needed), Site Initiation, Monitoring, and Close-Out Visits in accordance with the protocol and SOPs
•Perform in-house and on-site management functions for ongoing clinical studies at Organogenesis in accordance with the protocol, SOPs, GCP guidelines, FDA or other applicable regulatory agency requirement.
•Manages and maintains effective communication via written, oral, and or/electronic contacts with investigators, CRO and outside vendors to ensure protocols and GCP guidelines are followed throughout the study
•Develops and tracks study timelines
•Develops and reviews study-related documents, including study protocols, informed consent documents, study manuals and plans, study files, case report form design, etc.
•Develops, reviews, revises clinical SOPs; implement and train clinical affairs personnel.
•Manages clinical projects from concept through clinical study report/publications of
•Participates in and prepared to present materials to clinical sites, cross-functional internal meetings with internal and external resources
•Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
•Assist with data cleaning activities during study close outs.
•Maintains awareness of overall developments in the field of clinical research and clinical monitoring based on current literature, attendance at professional meetings, continuing education, etc.
•Completes all clinical, corporate, and project specific training and attends meetings as required.
Requires a Bachelor’s degree (BA, BS or BSN) from a four-year college or university in a scientific discipline or equivalent combination of education and work experience plus minimum of two years clinical research experience. Knowledge of GCP/FDA/ICH regulations required. Have an extensive and broad understanding of clinical research Experience with EDC systems Computer proficiency, including Microsoft Office applications