Lead Clinical Trial Coordinator BWH Cardiovascular

3 weeks ago

Boston, United States Brigham and Women's Hospital Full time

The Cardiac Imaging Core Lab (CICL) is located within the Brigham and Women's Hospital, a Harvard-affiliated hospital that is situated directly adjacent to Harvard Medical School. The CICL provides cardiac imaging core laboratory services for large-scale national and international clinical trials. The CICL is an academic-oriented research organization that works with academic, government, and industry partners and collaborators nationally and internationally. Working under the direction of CICL Directors and the Operations Director, the Lead 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. The Lead CTC will interact with research collaborators within other Harvard departments and at other institutions across the U.S. and other countries around the world.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Day-to-Day Study Operations

* 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.

Data Management

* 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.

General

* 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.
* Identify and initiate communications with sites to obtain all relevant documents for project/trial.
* 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.
* Contribute to the preparation of the department/trial specific SOPs and working instructions in accordance with operations guidelines, sponsor protocol, FDA requirements, and audit procedures.
* Contribute to the identification and implementation of process improvement opportunities.
* Prepare and maintain study aides and training materials.
* Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
* Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases.
* Generate reports as needed from internal and external databases.
* Understand audit trails and discoverable information.
* Collaborate with internal and external stakeholders.
* Assist and support other team members as needed.
* Maintain department service standards, with particular attention to person/behavioral, staff teamwork, and customer-staff interacting guidelines as outlined in the BWH Code of Conduct.
* Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines, and standards relating to department/trial(s).
* BA/BS degree in biological sciences or health administration.
* 2-3 years of relevant experience required
* 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.

SKILLS/COMPETENCIES REQUIRED

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.
* Proficiency in MS Office products (Outlook, Word, Excel, and PowerPoint) and familiarity with databases

SUPERVISORY RESPONSIBILITIES

None.

WORKING CONDITIONS

The CICL supports a hybrid work model. This position is M-F during core business hours. There is no patient interaction in this position.

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