Since 1984, the TIMI Study Group has been an Academic Research Organization dedicated to advancing the knowledge and care of patients suffering from cardiovascular disease and its risk factors. We have led a wide array of clinical trials, from phase I to phase IV, enrolling from less than 30 to more than 26,000 subjects, and with both industry and NIH support. Trials have been conducted in over 50 countries and at more than 5000 separate sites.
The Clinical Trial Coordinator is part of the trial operations team, tasked with ensuring that each project is completed in compliance with the trial protocol, good clinical practice, regulatory requirements, and to sponsor/TIMI standards. Working independently and under general supervision, the Clinical Trial Coordinator will support one or more clinical trials and will be responsible for assigned administrative day-to-day project activities.
Candidates for this position should have a strong interest in clinical research and clinical trials. This position would be ideal for those candidates interested in gaining significant experience in medical research and learning from experienced clinicians and clinical trialists. To that end, though not formally within the expected scope of the position, the successful candidate will be encouraged and supported in seeking educational opportunities and training.
Job duties may include, but are not limited to:
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.
Update and maintain internal databases, tracking systems, project plans, and study files.
Prepare presentation materials for internal and external meetings. Draft meeting agendas and minutes.
Work with Project Manager to support trial processes and distribution of information and reports to monitors in both North America and internationally.
Facilitate the implementation and ongoing process improvement of established policies and procedures for department/project/trial. Comply with applicable SOPs.
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).
Perform other tasks, special projects, and responsibilities as directed.
Bachelors degree and 1 to 2 years of research-related work experience
Familiarity with EDC and CTMS systems preferred
Proficiency in MS Office products (Outlook, Word, Excel, and Powerpoint) and familiarity with databases
Proficiency in Adobe Acrobat applications preferred but not required
Highly detail oriented, strong initiative, and a can-do attitude
Customer service oriented
Excellent organizational skills
Solid written and verbal communication skills
Strong sense of accountability, the ability to work autonomously, and as a team player
Ability to communicate effectively in a matrix environment
Ability to manage multiple tasks concurrently and to prioritize work appropriately
Ability to demonstrate professionalism
Willingness to ask questions when in doubt
Familiarity with drug development, clinical research processes and documentation, (study start up, maintenance phase, and study close out procedures) preferred but not require
Busy office environment with frequent deadlines
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.