Working very independently and under very general supervision from a Principal Investigator, provides support to clinical research studies. The position may include being responsible for the following activities: making independent judgement of suitability of potential participants for clinical trials, developing and implementing patient recruitment strategies, recommending changes to protocols, undertaking data collection and analysis, and overseeing the work of more entry level staff.Coordinates the implementation, both internally and externally, of sponsored clinical research studies.Working in concert with Principal Investigator and/or Research Manager, develops and implements patient recruitment strategies. Recruits and evaluates potential study patients. Per protocol instruction, conducts telephone interviews or schedules patient for study visit and screening. May be required to perform clinical tests such as phlebotomy, EKGs, etc.Maintains contact with study participants and coordinates study visits to obtain magnetic resonance imaging data and other evaluationsAnswers any phone calls and inquiries regarding study protocol. Refers participants when appropriate to supervisor or clinical staff.Responsible for coordination and implementation of infant and childhood follow-up of study participants, including coordination with multidisciplinary staff.Develops, organizes, and/or maintains detailed clinical and research databases. May use programs such as excel and REDCap. Responsible for data validation and quality control.Responsible for collecting data and maintaining patient information database for study. May be required to input data, do basic data analysis and run various reports. Maintains patients' records as part of record keeping function.In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval.Recommends changes to research protocols and manages modifications to institutional review board protocols.Performs literature searches, as appropriate.Performs basic laboratory testing on human blood and urine samples after training. Assists PI or Research Manager with preparation for presentation and written published articles.Responsible for training and orienting new staff. May serve as a team leader or in a supervisory capacity in a smaller area.Orders lab supplies and equipment as necessary.Assists PI with administrative tasks including scheduling, meeting coordination, preparation of meeting materials, etc.Responsible for data analysis, including learning and performing application of magnetic resonance imaging analysis.Maintains collaborative, team relationships with peers and colleagues. Attends meetings as required. Responsible for assisting with the creation of case report forms (CRF), standard operating procedures (SOP), study visit checklists and any other study related materials as needed.All other duties as assigned.Qualifications
PRINCIPAL DUTIES AND RESPONSIBILITIES:
BS OR BA
At least one year of work experience in a (preferably pediatric or neuroscience) research setting. Comfortable working in an acute care setting. Sound independent judgement and competence in research methodologies.
Preferred: Past experience, and knowledge of working with industry sponsored with Phase I/II IND clinical trials. Experience with adherence to Good Clinical Practice (GCP) and FDA guidelines and local regulationsEEO Statement
BWH is an Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.