- Provide clear and consistent organization of each assigned trial's status with strong attention to detail; this includes hands-on tasks such as tracking media received, inventory control, ensuring proper follow-up of pending project tasks and overseeing project timelines.
- Ensure smooth and efficient internal day-to-day operations for each assigned study. This will include serving as the primary liaison with physician staff to answer questions, track progress and field queries.
- Serve as the primary liaison to the Study sponsors and/or Data Coordinating Centers for day-today operations; this may include issues related to specific events or address project-wide issues, key person involved in other key communique such as site visits, study meetings and audits.
- Maintain appropriate document control standards per SOPs.
- Creation of new, and management of existing CICL databases.
- Responsible for generating both study-specific progress reports and data as well as generating center-wide cumulative data and progress reports.
- Work with Study Sponsors and/or Data Coordinating Centers along with the CICL Clinical Data Coordinator to ensure proper data management, including data transfers of final data to study Sponsors.
- Facilitate the implementation and ongoing process improvement of established CICL Policies and Procedures; responsible for monitoring the effectiveness and adherence to policies, generation of new policies, prn.
- Provides other support as per the CICL Directors as it relates to the overall research scope of the CICL.
- BA/BS degree in biological sciences or health administration.
- 1-2 years of research-related experience preferred
- Highly proficient in Word and Excel, knowledgeable of Access and PowerPoint and be generally comfortable working with computers.
- Has an interest in clinical research and/or trial project management and have a basic understanding of FDA regulations, ICH and GCP guidelines concerning human subject research.
- Identify and initiate communications with sites to obtain all relevant documents for project/trial.
- Collect and review essential regulatory documents for completeness prior to submitting to
- Regulatory for final review and/or approval.
- Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
- Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
- Identify issues/trends that require escalation to management and provide input to resolution as appropriate.
- Update and maintain internal databases, tracking systems, project plans, and study files.
- Prepare presentation materials for internal and external meetings. Draft meeting agendas and minutes.
- Work with Project Manager to support trial processes and distribution of information and reports to monitors in both North America and internationally.
- Facilitate the implementation and ongoing process improvement of established policies and procedures for department/project/trial. Comply with applicable SOPs.
- Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trial(s).
- Perform other tasks, special projects, and responsibilities as directed.
- Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with Databases
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Description
The Cardiac Imaging Core Lab (CICL) is an academic research organization located within the Brigham and Women's Hospital, a Harvard-affiliated hospital.
The CICL provides echocardiography core laboratory services for primarily large-scale global clinical trials responsible for site training and interface as well as echo analysis of images received.
The CICL works primarily with sponsors, CROs, and clinical trial sites which send echos directly to the CICL.There are approximately 40 staff supporting 40 clinical trials ongoing at any given time with a typical volume of echos received each month.
Working under the direction of CICL Directors and the Operations Director, the Clinical Trial Coordinator (CTC) will be an integral member of the CICL and will be responsible for assisting with day-to-day project activities such as image receipt, progress reporting, data transfers, communications with study sponsors, study sites, and study team members.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Day-to-Day Study Operations
Given this is a project environment and multiple projects will be assigned, and given that each project will have unique project demands, staff, deliverables and timeline, the ideal candidate is:
* highly organized and systematic in work processes
* self-motivated and proactive; able to identify, track, and drive issue resolution with little or no supervision or prompting
* able to function at a high level in a dynamic and busy environment
* able to take direction from, as well as influence and establish strong working relationships with a wide variety of individuals at all levels; ie. other Center project staff, technical staff, Directors, enrolling sites, Sponsors and other affiliate groups
* very dependable and able to demonstrate a respect for the importance of how work practices affect data quality
* able to communicate concisely and effectively, without undue delays, both verbally and in writing
* a clinical research professional, or aspires to become one, with an interest in cardiovascular medicine, human subject research and clinical trial project management.
SUPERVISORY RESPONSIBILITIES
None.
WORKING CONDITIONS
The CICL supports a hybrid work model however in-office collaboration with CICL team members is required. This position is M-F during core business hours. There is no patient interaction in this position.
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