Senior Research Coordinator
Senior Research Coordinator
Duties & Responsibilities:
- Supports Government directors, PIs, in the planning, programming, and execution of clinical research projects and protocols and associated activities.
- Maintain study records related to participation in accordance with protocols, study schedules, participant observation, and provides follow up documentation to the PI.
- For human studies, assists with activities related to the conduct of the study to include but not limited to study enrollment and follow-up.
- Coordinates multiple, concurrent projects for the PI/director; confers with investigator on experimental design; provides instruction on various research laboratory techniques, and study participant contact procedures.
- Organize research information; manages reporting and data collection.
- Monitors comprehensive research study budgets.
- Research equipment/supply catalogs, and recommend purchase requests for projects/protocols in accordance with the IRB.
- Documents all regulatory research and administrative actions needed for study compliance.
- Prepares/delivers required reports and other research documentation to PI.
- Prepares correspondence, creates and maintains study files, develop study schedules, and presentation graphics to support the research study.
- May require occasional weekend and evening hours.
Minimum Qualification and Experience:
- Required: B.S in Biological Sciences; Masters highly preferred.
- 5-8 years’ minimum experience in clinical research.
- Preferred candidate will hold a current certification, such as Certified Clinical Research Coordinator (CCRC).
- Demonstrated competence in oral and written communication.
- Demonstrated experience managing multiple concurrent clinical projects (5+ years)
- Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor.
- Intermediate+ experience with Microsoft Office applications including: Word, Excel, PowerPoint, Outlook, Access, Publisher, and SharePoint.
- Intermediate+ experience with Adobe Acrobat and internet applications.
- Experience in use of computerized information systems related to Human Subjects Research required (i.e. eIRB or related software).
- Successful completion and maintenance of Human Subjects training / training in human subjects' research protection, bioethics, and HIPAA.
- Demonstrated experience in the application of CFR, GCP and ICH guidelines.
- Successful completion GCP training and familiar with GCP in practice.
- Demonstrated FDA regulatory experience.
The position is contingent on government funding.
CITIZENSHIP AND CLEARANCE REQUIREMENTS:
- Must be eligible to work in the US.
- Must be able to pass a National Agency Check with Inquiries (NACI).
CICONIX, LLC is an Equal Opportunity Employer. We E-Verify all employees.
- Competitive market-based salary, commensurate with experience and education
- Comprehensive benefits available (Medical, Dental, PTO, 401k etc).