Clinical Competency, Clinical Practices/Protocols, Clinical Research, Data Collection, Data Entry, Data Quality, Database Administration, Detail Oriented, Employee Retention, File Maintenance, GCP (Good Clinical Practices), Informed Consent, Leadership, Organizational Skills, Record Keeping, Regulatory Submissions, Research Protocols, Research Skills, Team Player, Time Management
- 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.