Clinical Rsch. Coord., Sr.

GENERAL SUMMARY/OVERVIEW STATEMENT: Flexible and dynamic work environment Work collaboratively on innovative trials in Inflammatory Bowel Disease Tremendous potential for growth in the medical, pharmaceutical, or regulatory affairs fields The MGH Crohn's and Colitis center in the Digestive Healthcare Center at the Massachusetts General Hospital seeks a highly motivated, self-directed individual for the position of Senior Clinical Research Coordinator (CRC) for management of clinical trials.

This individual will be responsible for all study tasks related to data and sample collection for ongoing clinical trials including subject enrollment, capturing clinical data, scheduling, conducting study visits, processing biologic specimens and maintaining relationships with collaborators and sponsors. There will be a strong focus on regulatory start-up, patient recruitment and retention, as well as completing clinical trial related tasks. The schedule may require some flexibility with earlier or later hours during the work week to accommodate patient schedules.

An ideal candidate would possess a biology or data analysis background and also have a minimum of 3-5 years clinical research experience. Prior experience with clinical trial management and execution and/or experience with regulatory or project management experience would be strongly preferred. This position offers the opportunity to work directly with a motivated patient population and expert physicians and learn the basics about clinical trials in a large academic medical center.

It offers tremendous potential for growth in the medical, pharmaceutical, or regulatory affairs fields. PRINCIPAL DUTIES AND RESPONSIBILITIES: Clinical Trial Responsibilities Manage study operations and ensure integrity of study Facilitate IRB submission process by preparing protocol applications, protocol amendments, safety reports, and other required documents.

Manage and maintain regulatory documents for audit by sponsor or FDA. Assist recruitment and/or randomization of subjects per study protocol Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion per study protocol; coordinate subsequent assessments of subjects as outlined in study protocol Assess subject's health through interviews; take subjects vital signs Perform phlebotomy (if certified) on subjects; process and ship specimens Coordinate subject care by scheduling follow-up assessments and communicating concerns about the subject with the study investigator and the subject's primary care provider Maintain subject charts and other data per the protocol and assess data for quality and completeness Conduct ongoing review of study progress and provide investigators with progress reports Coordinate and facilitate site sponsor visits SKILLS/ABILITIES/COMPETENCIES REQUIRED: Excellent analytical skills and the ability to resolve technical or research problems and to interpret the acceptability of data results Highly motivated, self-directed and driven to meet study goals Excellent communication skills and willing to assume study leadership role Ability to manage time independently, effectively and efficiently Ability to juggle multiple tasks, people and schedules.

High degree of computer literacy, knowledge of Microsoft Office suite Ability to demonstrate professionalism and respect for subjects' rights and individual needs Must have the ability to prepare and monitor budgets, to identify problems and develop solutions, prioritize tasks and set deadlines. SUPERVISORY RESPONSIBILITY: This position may have oversight of other CRC I/IIs as needed.

This could include assistance with the orientation and training of new coordinators, under direction of the PI. WORKING CONDITIONS: Position includes conducting subject visits within a medical office setting, and handling biological specimens following universal precautions for blood/stool processing, handling and shipping.

Day shift with flexibility for evening/weekends depending on time management and patient schedules EDUCATION: BA/BS degree required EXPERIENCE: Minimum 3-5 years full time research experience in a clinical setting required.

Experience in investigation drug studies strongly preferred. Minimum 1 year of industry sponsored clinical trial experience and IND application experience required. Biology and/or laboratory science background preferred, but not required Biostatistics background preferred, but not required