clinical research coordinator ii bwh rheumatology - Boston, MA , USA, United States - Partners Healthcare System

Description

The BWH Lupus Program, within the Division of Rheumatology, Inflammation, and Immunity at the BWH, is a large and multidisciplinary clinic and affiliated clinical and translational research program, with a large and growing patient registry (> 3,500 currently) and many ongoing and anticipated studies and trials.

The BWH Lupus Program clinical coordinator and clinical data manager will work on several federal, foundation and industry-funded clinical studies and health interventions together with Principal Investigators and study staff.

They will be responsible for coordinating and carrying out many Lupus Program and study-related activities, including identification, data collection and follow-up of all patients seen in the BWH Lupus Center with potential or diagnosed lupus, recruitment and follow-up for studies and trials, patient interviews, follow-up appointments, patient education, and data collection, and data management for the Lupus Registry and for regulatory oversight and clinical data coordination for all lupus clinical studies and trials.

They will need to be able to work under general supervision of the PIs, but will need to be independent, organized, efficient, and responsible.

The Lupus Program coordinator will also organize and coordinate meetings, events, and newsletters for the BWH Lupus Program.

The coordinator will also help represent the BWH Lupus Program in the LUCIN network of the Lupus Research Association (LRA) and will be the project manager/and or coordinator for LUCIN studies done at BWH.

This position provides an opportunity to engage in a dynamic, clinical research setting and is ideal for the candidate with prior background in clinical research or public health administration.

Principal Duties and Responsibilities:

Responsible for drafting IRB documents including consent forms, IRB submissions and amendments as well as other regulatory and guidance documentation.

• Organizes recruitment for clinical research studies and identifies potential subjects, following study criteria. Keeps organized, accurate, and up to date databases and maintains up to date records on all Lupus Registry and study subjects.
• Contacts and collects data on subjects in clinical research studies. This may include the administration of study questionnaires either in person or on the phone.
• Performs follow-up on patients experiencing adverse events in large clinical trials. This will include working with other study staff to obtain medical records, create adverse

event adjudication files, and updating the study database with results and following through on reporting.

• Codes and enters data according to written protocols.
• Provides information such as recruitment and data collection details for manuscript and abstract writing, completion of progress reports, IRB human subjects new submissions for research protocols, annual reviews, and presentations (including preparation of graphics).
• Contributes to drafting of progress reports, human subjects' annual reviews, and protocols for executing projects in accordance with proposed aims and methodology.
• Drafts formats for questionnaires, surveys, interviews and other instruments as needed for research projects, assuring ease in administration and accuracy of data entry.
• Performs all other BWH Lupus Program duties as requested.
• Attends LUCIN related activities and events, including national meetings.

Qualifications:

• Proficiency in writing; excellent verbal and written communication.
• Bachelor's degree required. MS preferred (for manager position)
• Minimum 1 year of Research experience.
• No specific license/certification or registration is required.
• Excellent interpersonal and organizational skills required. Strong references necessary

Skills/Abilities/Competencies Required:

• Keyboard/typing skills.
• Must have interpersonal skills to interact effectively with persons with chronic disease to gain their cooperation in the research projects and allay apprehensions.
• Must be able to prioritize and organize work responsibilities in order to meet deadlines so as not to hamper the progress of the studies.
• Must possess integrity to maintain confidentiality.
• Must demonstrate accuracy in recording data.
• Must be able to make independent judgments under general supervision for the above mentioned job duties and responsibilities.