Clinical Research Coordinator I, DOM Hematology

Principal Duties and Responsibilities:

Oversees and coordinates daily operations of research studies according to study Protocol requirements, Institutional Review Board (IRB), and Hospital policy and procedures. Ensures compliance and consistency of informed consent procedures and related activities. Participates in Bleeding Disorders Clinic at Brigham and Women's Faulkner Hospital weekly and also provides coverage at the Bleeding Disorders Clinic at Boston Children's Hospital when required. Interacts directly with study participants and the multidisciplinary treatment team. Identifies eligible patients per protocol guidelines and consents subjects for the CDC Community Counts project. Registers and updates as appropriate patient information using relevant databases and portals. Responsible for completion, collection, and tracking of all study and forms. Maintains patients' study binders and source documents. Creates, edits and maintains standard operating procedures (SOPs) for clinical trials. Reviews medical records of study subjects for data collection and extraction for study purposes, performs data entry to study's portals and databases, and resolves errors and discrepancies. Performs procedures necessary for proper sample preparation and delivery to collaborating labs. Ships study samples/specimen as appropriate, following guidelines as outlined by protocols. Maintains and provides site's regulatory documents to external sponsors. Assists in submissions of New Study Applications for Institutional Review Board, provides responses to IRB requests for information, annual continuing reviews, protocol amendments and adverse event reporting per Sponsor's and IRB guidelines. May be expected to participate in formal and informal presentations of protocols and results to staff. May also collaborate in developing articles for journal publications and making presentations at conferences and meetings. Will attend webinars and other regularly scheduled meetings as assigned. Other duties as assigned.

Skills and Abilities required:

• Bachelor's degree required.
• Proficiency with Microsoft Office and other programs.
• Ability to handle multiple tasks simultaneously, prioritize, and meet deadlines.
• Excellent communication skills and sensitivity to confidentiality issues; diplomacy and discretion.
• Ability to work collaboratively as part of a team.
• Ability to work with minimal supervision and good judgment as to when to seek advice.
• Excellent English language skills for writing, editing and proofreading.
• Zero to two years of work experience in a health care setting preferred.