Clinical Trials Proj Mgr II

The Clinical Trials Project Manager II for NCORP is responsible for leading the planning, implementation, and monitoring for multiple, large, national, multi-site clinical research protocols in a network of over 800 community sites. Under oversight of the Manager of Clinical Trials Projects, the Clinical Trials Project Manager will manage multiple studies’ day-to-day operations, carry out project management for clinical trials run through the URCC NCORP network from protocol development and initiation to study close-out according to regulatory/NCI guidelines, and ensure each study’s integrity. S/he will monitor and maximize adherence to research standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty/study sites from all cross functional teams to ensure study participant safety and adherence to study protocol; manage study-related tasks; and facilitate across-the-board flow of information, orchestrating study activities and personnel. The Clinical Trials Project Manager will facilitate excellent customer service and guidance to clinical and study teams in the clinical trials environment. This role is fully on-site with no remote work with standard work hours between 7am and 5pm.

Responsibilities

Serve as primary contact for protocol and data-related questions and issues from off-site locations; Ensure off-site investigators and clinical research staff understand and adhere to assigned protocols, procedures, and interventions; Train sites research staff on study activities, including inclusion/exclusion criteria, informed consent, source documentation, CRF completion, and adverse event reporting; Monitor studies for conformity and verify data compliance; Track study-specific metrics and resolve issues; Maintain working knowledge of software, procedures, and interventions; Develop and maintain workflows and reports; Ensure protocol timelines met; Report adverse events; Present updates at weekly study management team meetings; Oversee data handling procedures and incoming data from community sites; Collaborate with data management, IT, regulatory, biostatistics, and data science teams; Develop and produce reports on study data; Manage assigned project during development and launch; Work with clinical trial team on protocols, procedures, and training materials; Coordinate study supplies and equipment; Serve as site auditor; Travel approximately 1-3x/year for meetings or conferences

Requirements

Bachelor's degree and 2 years of relevant experience; or equivalent combination of education and experience; Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials; Strong communication skills, interpersonal skills, attention to detail, and organization skills

Nice to have

2-3 years of clinical trials experience; Excellent communication and organizational skills; attention to detail and problem-solving skills; Ability to handle several projects simultaneously, prioritize, and shift priorities quickly; Knowledge of computer databases, word processing, spreadsheets, and graphics packages; Clinical trials project management experience; CCRP - Certified Clinical Research Professional; Certified Project Management Professional (PMP)-PMI