Clinical Research Coordinator

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The candidate will work with an internationally recognized, multidisciplinary team from Massachusetts General Hospital and Harvard Medical School, alongside collaborators from many institutions. Specific studies include large observational database research and research that includes enrollment of patients into cohort and clinical trial studies. Primary conditions studied include vasculitis and IgG4 related disease.

Working very independently and under very general supervision from Research Manager and/or Principal Investigator, provides support to clinical research studies. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials and registries, screening and scheduling potential participants for clinical trials, developing and implementing patient recruitment strategies, performing applicable clinical tests such as phlebotomy, vital signs, ECGs, etc. maintaining and updating data generated by the study.

JOB DESCRIPTION:

1. Working with other research coordinators supporting clinical research activities for department.
2. In conjunction with Research Manager/Principal Investigator, develops and implements new research protocols including design, data collection systems and institutional review board approval.
3. Recruitment of patients for enrollment in clinical trials and registries. Interacts with patients prior to entering the study and throughout the entire treatment. Discusses and obtains informed consent with patients.
4. Organizing strategies for recruiting study patients.
5. Screening patients for eligibility and enrolling eligible candidates.
6. Conducting study visits.
7. Working closely with the Principal Investigator and other staff on implementing clinical studies and registries.
8. Preparation of protocol applications, maintaining regulatory binders, case report forms, source documents, and other study documents as well as monitoring and reporting the occurrence of clinical adverse events.
9. Maintaining and updating information as required by Hospital and Sponsor/NIH guidelines.
10. IRB applications and submission
11. Manage study finances: maintain positive financial status of studies, prepare invoices and track payments, facilitate subject payment and reimbursement as applicable per study contract

Investigator support

1. Organize meetings and meeting schedules
2. Manuscript and presentation preparation: literature reviews, citation management, drafting, basic data manipulation, table and figure creation
3. Clinical operations support as needed

EDUCATION:

1. Bachelor's degree required.
2. New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Coordinator I position outlined above.
3. Those with a minimum of 1-3 years of directly related work experience will be considered for a Clinical Research Coordinator II position.
4. Experience with Good Clinical Practice, CRFs, laboratory processes, safety practices, specimen shipping/handling, and study conduct.

SKILLS:

1. Ability to work independently.
2. Excellent interpersonal skills are required for working with the study participants.
3. Good oral and written communication skills.
4. Analytical skills and the ability to resolve technical or research problems and issues and to interpret the acceptability of data results.
5. Knowledge of clinical research protocols.
6. High degree of computer literacy.
7. Excellent organizational skills and ability to prioritize a variety of tasks.
8. Careful attention to detail.
9. Ability to demonstrate professionalism and respect for subject's rights and individual needs.

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.