Clinical Research Coordinator, I

Education
Bachelor's Degree Science required

Experience
Some relevant research project work 0-1 year preferred

Knowledge, Skills and Abilities
- Careful attention to detail and good organizational skills.
- Ability to follow directions.
- Good interpersonal and communication skills.
- Computer literacy.
- Working knowledge of clinical research protocols.
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Schedule and conduct study visits in the Men's Health Clinical Research unit. Coordinate study procedures to be conducted outside the unit at the Laboratory of Exercise Physiology and Physical Performance and at other institutional research locations. Administer consent to study subjects following Good Clinical Practice (GCP) guidelines. Participate in the development and implementation of subject recruitment strategies. Monitor and report the occurrence of adverse events as dictated by the guidelines of the sponsor and the governing IRB. Prepare for and facilitate monitoring visits and quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Assist in developing corrective action plans when required. Respond to queries, if any, in a timely manner. Review electronic medical records to pre-screen patients for study eligibility. Perform medical record abstraction for study relevant data. Perform basic study assessments on study subjects, such as anthropometric measurements, vital signs, and electrocardiogram (EKG). Prepare summary reports for project team regarding enrollment status and study progress. Prepare IRB submissions to multiple IRBs (initial submissions, continuing reviews, amendments, exceptions, etc.). Contribute to the development of study specific documents, e.g., case report forms (CRFs), eligibility screening scripts and questionnaires, informed consent forms, protocol summaries, and subject recruitment materials. Maintain study regulatory documents and ensure study compliance with all government, sponsor, and IRB requirements. Contribute to the preparation of posters, abstracts, and manuscripts for publication. Assists PI with preparation of slide presentations and participates in presenting slides to other study staff and outside collaborators when necessary. Construct and maintain study database as well as perform data entry on an ongoing basis. Assure adherence to intended timelines and achievement of study goals. Develop and implement measures to improve efficiency in office operations. Provide coverage for other study coordinators as needed. Perform additional tasks as assigned.

QUALIFICATONS:

Bachelor's degree. Proficiency in Microsoft Office applications (Outlook, Word, Excel and PowerPoint). Familiarity with electronic data capture (EDC) systems preferred (e.g. REDCap and StudyTrax). Intermediate knowledge of medical terminology preferred. Certifications in the Protection of Human Subjects and Good Clinical Practice, per institutional and regulatory guidelines.

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

Excellent organizational skills and an ability to effectively manage time and prioritize workload. Strong oral and written communication skills. Excellent critical thinking and problem-solving skills. Analytical skills necessary to accurately interpret and implement complex policy. Comfortable working both independently and as part of team. Excellent interpersonal and relationships skills. Ability to build rapport and interact effectively with a broad array of people from diverse cultural and educational backgrounds. High degree of professionalism, discretion, and confidentiality.