Clinical Research Project Coordinator

Boston Area Based, a full-time, hybrid position.

CCS is seeking a highly motivated, self-driven Core Lab Clinical Research Project Coordinator to work in a fast-paced clinical research core lab environment. This role is responsible for the management of clinical imaging data (e.g. PET, CT, Echo, and Hemodynamic tracing) for clinical research trials, including; data entry and project coordination, as well as receipt, review, reconciliation, and transfer of data coming from clinical study sites worldwide. The Core Lab Clinical Research Coordinator is critical in establishing and maintaining data integrity and patient safety.

At the direction of the Director of Core Lab Operations, the Core Lab Clinical Research Project Coordinator is responsible for managing various image transfer and processes for the Cardiovascular Clinical Sciences Core Laboratory. This individual must have the ability to manage time-sensitive project cycles, as well as interact collaboratively with colleagues to achieve study goals within designated timelines. The position requires impeccable organizational skills due to the scope, complexity, and dynamics of clinical trials.

Essential Job Functions, Duties and Responsibilities:

• Data entry in electronic data capture systems, tracking, and reconciliation.
• Compile and maintain project-specific status reports and project timelines.
• Communicates with sponsors, CCS staff, imaging readers, and site staff to ensure an understanding of the requirements of conducting and participating in clinical trials.
• Electronic transfer of imaging data between clinical study sites, including PET, CT, Echo, and Hemodynamic tracing data.
• Troubleshooting; support for clinical study sites participating in trials.
• Resolve transfer errors and permission access privileges.
• Coordinate core laboratory pre-study activities in accordance with the sponsor’s scope of work, CCS SOPs, and GCP guidelines.
• Update and maintain Project Tracking Logs as required.
• Interact with consultant image readers.
• Follow document management policies of projects.
• Ensure adherence to image format protocol/guidelines.
• Maintain all required Quality Assurance training (i.e., SOPs, CV, etc.) in a timely manner.
• Provide other imaging project support as assigned.

Experience:

• 1-3 years of clinical research experience.
• A basic understanding of medical imaging.
• Familiarity with various image archiving and image transfer systems.

Education, Knowledge, Skills, and Abilities:

• B.A. or B.S. degree in the scientific field or equivalent experience
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute imaging study activities.
• Ability to manage multiple priorities within various imaging studies.
• Ability to reason independently for the purpose of assessing and recommending specific solutions.
• Ability to set baseline targets, track trends and implement mitigation plans.
• Understanding of basic medical imaging processing functions.
• Working knowledge of current ICH GCP guidelines.