Clinical Trials Proj Mgr II

University of Rochester•City of Rochester, NY

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

Manage all aspects of assigned high volume, multisite clinical research projects including: Serve as the primary contact for protocol and data-related questions and issues from off-site locations.
Ensure off-site investigators and their clinical research staff understand and adhere to all aspects of assigned protocols, procedures, interventions, and standards for documentation and communication
Train sites research staff on details of study activities, including inclusion and exclusion criteria, informed consent procedures, process for source documentation and case report form (CRF) completion, and adverse event reporting.
Assist with monitoring the studies regularly for conformity with standard operating procedures and verify data to ensure compliance with requirements of the protocol, Research Base, IRB, University and federal regulations.
Track study-specific metrics (i.e., overdue data, open queries, etc.) and ensures issues are addressed promptly.
Learn and maintain working knowledge of software and/or specialized equipment, procedures and interventions used in each project.
Develop and maintain workflow, records of research activities, and prepare periodic, and ad hoc reports, as required by investigators and/or regulatory bodies.
Ensure protocol timelines are met (e.g., patient, study, data).
Ensure proper reporting of adverse events to PI and Research Base Administration.
Attend and present updates at weekly study management team meetings.
Maintains oversight of high-volume study data for the assigned projects: Work with Clinical Trial Chairs, Co-Chairs, Data Management, IT, Regulatory, Biostatistical, Data Science, and other relevant teams to establish appropriate data handling procedures, methods for collection, databases, coding keys, storage, and tracking of data for assigned projects.
Oversee receipt and verification of incoming data received from our community sites in multiple formats, i.e., REDCap, scannable paper forms, activity trackers, electronic cognitive assessments, heart rate monitors and audio recordings of treatment sessions.
Works collaboratively with Data Management to provide the study team and URCC leadership with accurate reports on status of data for assigned projects including – data processing status, outstanding data, and trends.
Analyze and suggest improvements in flow of information, error detection/correction, etc.
Maintain database integrity; review and evaluate patient data for statistical analysis, work with biostatistics team to resolve discrepancies or problems
Develop and produce reports of study data for project staff and stakeholders, including study deviations and adverse events.
Contributes meaningful information to enhance publications or grant applications.
Manages the assigned project during the critical development and launch period and is responsible for working with the URCC NCORP Research Base leadership, Clinical Trial Chairs and Co-Chairs, as well as all cross functional teams to assess the scope of work, deliverables, timelines, milestones and relevant metrics to track progress and ensure all deadlines are met successfully.
Work with the clinical trial team in the development of work flow and protocols, data collection methods, training materials, amendments, and all other trial needs.
Determining what study supplies will be needed and ordered on schedule as outlined at project kick off, evaluating any changes in plans and needs for adaptation.
Collaborates with the clinical trial team and relevant functional groups to review and edit protocols and study-related documents and forms for new projects in development, maintaining a high level of attention to detail.
Works across teams to ensure all requirements are satisfied, questions are addressed, and URCC policies and procedures are followed.
Ensures Investigational Drug Service distributes study agent to off-site locations as applicable.
Works with the URCC Biobank, CCPL, and PEAK Lab to design and build any necessary laboratory data collection methods, laboratory manuals and training materials.
Obtain reports regarding data receipt and quality from URCC member sites.
Receive requests for and ship study-specific drug, supplies and equipment (e.g., devices such as activity trackers, heart rate monitors, TENS units, recording equipment, training materials, manuals) for active clinical trials.
Maintains shipping logs/database, monitors expiring supplies, communicates with sites as needed, and ensures timely replacement with in-date supplies.
Serve as site auditor, primarily reviewing selected patient cases to ensure compliance with protocol; assist Lead Auditor in compiling information gathered during the audit for the final report to the NCI.
Provide support and backup for projects assigned to other URCC CRPMs as needed.
Maintains current working knowledge of clinical research best practices, updates to federal regulatory, Good Clinical Practice, current industry standards for clinical research and project management professionals by regularly attending training sessions, meetings and conferences.
Needs to be available approximately 1-3x/year to travel overnight for meetings and/or conferences.
Other duties as assigned