Lead Clinical Trial Coord BWH Cardiovascular

Lead Clinical Trial Coord BWH Cardiovascular-(3302979)

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 (echo) core laboratory services for primarily large-scale global clinical trials, responsible for site training and interface as well as quantitative 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 1000 1500 echos received each month.

Working under the direction of the CICL Operational Director and study-specific Project Manager, the Lead Clinical Trial Coordinator (CTC) is an integral member of the CICL 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, various Sponsors, CROs, and with enrolling sites around the world.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Day-to-Day Study Operations

• Provides 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.
• Ensures 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.
• Serves 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.
• Maintains appropriate document control standards per SOPs.

Data Management

• Assists with the creation of new, and management of existing CICL databases.
• Generates both study-specific progress reports and data as well as center-wide cumulative data and progress reports.
• Works 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

• Facilitates 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.
• Advises research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
• Identifies issues / trends that require escalation to management and provide input to resolution as appropriate.
• Contributes to the preparation of the department / trial specific SOPs and working instructions in accordance with operations guidelines, sponsor protocol, FDA requirements, and audit procedures.
• Contributes to the identification and implementation of process improvement opportunities.
• Works with the department / trial manager(s) to address issues identified through periodic quality monitoring activities and / or audits.
• Prepares official trial correspondence (., numbered memos).
• Understands audit trails and discoverable information.
• Collaborates with internal and external stakeholders.
• Assists and support other team members as needed.
• Maintains department service standards, with particular attention to person / behavioral, staff teamwork, and customer-staff interacting guidelines as outlined in the BWH Code of Conduct.
• Demonstrates and maintain knowledge of regulations, clinical research conduct, laws, guidelines, and standards relating to department / trial(s).

Qualifications

• BA / BS degree in biological sciences or health administration.
• 2-3 years of relevant experience required
• Highly proficient in MS Office
• 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 / ABILITIES / 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.

SUPERVISORY RESPONSIBILITIES

None.

WORKING CONDITIONS

The CICL supports a hybrid work mode. This position requires in-office collaboration with CICL team members at least 3 days a week.

This position is M-F during core business hours.