Clinical Trial Coordinator CICL - Per Diem

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 (i.e., 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.
• 1-2 years of research-related experience preferred
• 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.