Senior Clinical Research Coordinator Psychiatry

The Sr. Clinical Research Coordinator assists Dr. Amit Anand in coordinating clinical trials and imaging/biomarker trials according to study guidelines, including performing testing, recruiting participants for studies, scheduling appointments, assuring completion of visits and accurate data collection and entry, assisting in IRB submissions, and interacting with regulatory personnel for local and multicenter trials. In addition, making independent judgement of suitability of potential participants for clinical trials, developing and implementing patient recruitment strategies, recommending changes to protocols and overseeing the work involved.

Interested applicants should include an up-to-date resume or curriculum vitae and a cover letter outlining how their interests and experiences would make them a good fit for this position.

Principal Duties and Responsibilities

• Initiates and maintains contact with study participants.
• Responsible for screening applicants, ensuring they meet appropriate criteria, and makes independent judgement as to the suitability of their participation. May be required to perform clinical tests such as phlebotomy, EKGs, structured interviews, ECT. Administers study related behavioral questionnaires.
• Working in conjunction with Principal Investigator and/or Research Manager, develops and implements patient recruitment strategies.
• Participates in the design of research methodology
• Develops, organizes and /or maintains the study database.
• Responsible for data validation and quality control.
• Recommends protocol changes and writes protocols
• Preparing study reports, annual reviews, and manages Institutional Review Board documentation, additions, and changes
• Monitoring and evaluating protocol compliance with internal and external regulatory bodies to ensure adherence to practical and ethical guidelines
• Assisting with data analysis and preparation of manuscripts and conference presentations
• Responsible for oversight of research assistant work, training and orienting new staff.
• May serve as a team leader or in a supervisory capacity in a smaller area.
• Independently performs specialized projects
• All other research and administrative duties as assigned by Principal Investigator

Requirements

• A bachelor's degree is required, with minimum 3 years directly related post Bachelor's degree experience required.
• Certification in clinical trials management strongly preferred.
• Minimum of one years experience working in clinical research, academic research, or similar environment is preferred.
• Exposure to clinical trials (such as prior research coordinator for interventional studies), or relevant employment in industry such as a CRO monitor is preferred. Clinical project management experience is preferred.
• Exposure to IRB preparation, interactions with CROs, site monitors, regulatory paperwork regulatory paperwork, consenting and interacting with study subjects, strict protocol adherence and archiving is preferred.
• Familiarity with working in a large healthcare organization/ academic center encouraged.
• Supervisory experience is required. Experience managing a team working across a matrix environment is preferred.
• Experience in financial aspects of clinical trial function such as invoicing and working with financial analysts preferred.

Skills & Competencies

• Excellent interpersonal skills are required for working with the study participants and multiple parties involved in the trials process.
• Ability to effectively manage individuals at various levels within the team is highly valued.
• Strong time management skills for ensuring implementation of several concurrent studies.
• Good oral and written communication skills.
• Ability to work independently day-to-day.
• Knowledge of computer programs, databases, etc.
• Excellent organizational skills and ability to prioritize a variety of tasks.
• Careful attention to detail.
• High degree of computer literacy
• Strong critical thinking skills and ability to independently resolve problems
• Working knowledge of data management software and procedures
• Working knowledge of clinical research protocols and Good Clinical Practice
• Ability to demonstrate professionalism and respect for subjects rights and individual needs.

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.