Date updated: 05/3/2018
Acts as a lead in the Clinical Research Coordinator Team supporting the Vice-President of Clinical Pharmacology Services in the clinical conduct of research studies at the clinical research center.
- Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic SOPs, OSHA guidelines, Federal and local regulations
- Completes all required training programs per company requirements and as applicable to study protocols
- Reports to Vice President, Clinical Pharmacology Services on all administrative, logistical, staff related site issues
- Responsible to the Principal Investigator (PI) on all medical and compliance aspects of study conduct for specific studies
- Ensures overall understanding of protocols and generally, serves as the back-up CRC on designated studies. May serve as a primary CRC as dictated by resource management, complexity of project, or other strategic considerations.
- Mentors, but does not directly manage/supervise, more junior CRCs with operational oversight of clinical conduct to ensure compliance
- Ensures Sponsor, CRO, and study participants confidentiality and HIPAA compliance
- Attends Site Initiation Visit (SIV), and other study related meetings as required
As per Job Description and as trained and delegated by the Medical Director or Principal Investigator and as allowed by sponsor:
- Leads the development and creation of clinical source documents, tools, and processes
- Ensures study binders and source documents are available for study conduct
- Performs quality checks on study documents
- Ensures documents are filed, organized and stored properly and in a timely manner
- Assists in ensuring activity time points are met
- Assists regulatory staff as needed
- Ensures study data entry and query resolution is completed in a timely manner
- Assists with training documentation and coordinating staff training
- If trained and delegated, performs study procedures (including EKGs/vital signs/meals/phlebotomy and lab processing)
- Organizes study supplies and overseeing study logistics
- Assists with recruitment activities and represents company at community events
- If delegated, performs informed consent process, and collects medical histories
Education and Experience
- Bachelors Degree or Higher in related, science or medicine related major.
- Previous clinical research experience (10+ years) preferred.
- Ability to work under pressure in a fast-paced environment with parallel and competing priorities
- Ability to work in compliance in a highly regulated environment
- Excellent verbal and written communication skills, presentation skills, as well as computer skills.
- Computer skills, including MS Word, PowerPoint, Excel, Outlook
- Excellent time management and critical thinking skills.
- Robust (10+ yrs) previous experience in a clinical research unit or CRC certification.
- Competent in performing medical tasks (such as taking vital signs, EKG, drawing blood, etc.)
- Ability to interact positively with all levels of staff and liaise successfully with all levels of management.
- Flexible Schedule
- Positive public relations skills with ability to provide positive first impressions to all visitors.
- Able to represent HPCTC in a professional manner at community events and meetings
- A strong team player.