Clinical Research Coordinator I

• Maintain awareness of status of all active studies.
• Participate in development and implementation of associated projects under the guidance of the research director.
• Identify potentially eligible participants.
• Conduct remote consent according to protocol specifications.
• Conduct pre-consent screening procedures according to protocol specifications to determine eligibility.
• Execute the informed consent process according to Good Clinical Practices (GCP), procedures and other applicable policies.
• Develop a rapport with study participants.
• Collaborate effectively with others to ensure proper progress and completion of studies.
• Conduct data entry and validation to ensure accuracy, quality, and compliance of the data collection process.
• Maintain the master database files for clinical research protocols.
• Document in applicable systems (tracking, electronic health, etc.) participants approached, screened, and enrolled in the study.
• Maintain detailed records.
• Compose clear, precise, and detailed correspondence.
• Communicate study related issues to investigators, sponsors, coordinating centers, study coordinators, clinical team, managers, and other institutions in a timely fashion.
• Communicate with participants' clinical team regarding study participation as indicated by protocol and/or manual of operations.
• Communicate challenges with recruitment and retention to the study leadership.
• Participate in preparation, review, submission, and maintenance of regulatory activities/submissions, ensure accuracy and timeliness to all collaborative parties.
• Prepare for and participate in monitor visits, audits, and quality reviews (internal and external) in a professional manner.

Knowledge, Skills, and Abilities:

• Knowledge of the principles, practices, and techniques of research clinical skills.
• Skill in completing tasks with attention to detail.
• Skill in using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, and approaches to problems.
• Skill in talking to others to convey information effectively.
• Ability to manage multiple concurrent deadlines.
• Ability to accurately prepare and maintain records, files, and reports.
• Ability to handle difficult and stressful situations with professional composure.
• Ability to understand and follow instructions.
• Ability to exercise sound judgment in making critical decisions.
• Ability to work evenings, overnights, and weekends.