Clinical Research Coordinator

• Maintain updated files on all on-going IRB studies and protocols including the correspondence of informed consent forms, marketing materials, and data collection forms.
• Maintain secure files on all protected study related data.
• Maintain updated information on study progress and participate in recruitment, consent, follow-up and other study procedures.
• Maintain a schedule of IRB related deadlines for annual study renewal and closure.
• Help with study-related follow-up calls when appropriate.
• Work with investigators on submitting study results at investigational meetings for publication.
• Maintain files on all presented and published study results.
• Maintain updated documentation of all IRB-required CITI training.
• Facilitate additional research items including but not limited to study registration on clinicaltrials.gov and assistance with Investigational New Drug (IND) items.
• Facilitate grant submissions and requests for funding.
• Ensure compliance with research protocols and federal regulations.
• Maintain Manual of Operations for clinical trials.
• Establish Data and Safety Monitoring Boards.
• Assist in tracking site enrollment, performance information, and subject study status and establish methods to track follow and maintain subjects.
• Screen and enroll research participants, obtain informed consent, including a review of medication histories to see if subjects are eligible for enrollment, conduct interviews with subjects, help patients to enter data on research data sheets (also known as eCRFS), and enter in the REDCap database. Act as liaison between patients, physicians, and staff members.
• Additional duties include assisting the PI with day-to-day affairs of the site activities as they relate to the clinical management of the Clinical Trial.

• Perform other duties as needed to support the timely completion of research projects that are consistent with established protocols.
• Participate in preparation of new research proposals.
• Work together with others in the study protocols, such as research coordinators, physicians and technicians.
• Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

• Bachelor's Degree preferred or equivalent combination of training and experience. ACRP-CCRC Certification preferred
• 1+ year experience in clinical research and project management preferred.
• Proficiency with MS Word, Excel and Publisher, Project Management software such as MS Project, EndNote, REDCap.
• Excellent written and oral communication skills.
• Ability to multitask, problem solve, set and meet deadlines, and take initiative.
• Knowledge and support of GWU's vision, mission statement, values, and guiding principles.
• Current knowledge of medical research standards, protocols, and regulations applicable to the position/Practice Area.
• Excellent interpersonal skills for communicating professionally, cheerfully, and effectively with study participants, families, physicians, and coworkers.
• Good written communication skills for the preparation of coherent research summaries.
• Proficiency reading documents and following written instructions.
• Ability to work well with others across differences and resolve conflicts when they occur.
• Familiarity with the technology/equipment utilized by the research project.
• Ability to demonstrate compassion, patience, and calmness in stressful situations.
• Integrity, with appropriate concern for confidentiality.
• Flexibility, initiative, and self-direction.
• Attention to detail and ability to manage multiple priorities.
• Attentive to quality and accuracy.

How is pay for new employees determined at GW?

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.