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Clinical Research Specialist - Norfolk, United States - Virginia Eye Consultants
Description
Job Description
Job DescriptionPOSTION: Clinical Research Coordinator
GENERAL DESCRIPTION
Under the direction of the Research Manager, the Clinical Research Coordinator is responsible for the coordination of research protocols, including subject recruitment, enrollment, and implementation and follow up of protocols. The Clinical Research Coordinator promotes good clinical practice in the conduct of clinical investigations by possessing knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject's protection.
DUTIES AND RESPONSIBILITIES
> Participate in subject screening, recruitment, enrollment and follow-up procedures, pre-study preparation, problem solving and maintenance of clinical trials.
> Read and have full understanding of research protocol.
> Collect, process, and ship research specimens, including blood draws, following appropriate training.
> Document and maintain all study related procedures and events on case report forms (CRFs) or electronic data
capture (EDC), participate in monitoring visits, review CRFs with the sponsor, handle data queries. Prepare
complex regulatory documents such as Human Investigation Committee (HIC) applications, Informed Consents, complex amendments, Progress Reports, Adverse Event (AE) Reports and Protocol Deviations.
> Communicate effectively with subjects, research team, principal Investigators, ancillary staff, study sponsors
and primary care providers.
> Consent and conduct study visits for device trials, data collection/no risk trials, and study article/some risk trials as appropriate to education, training and work experience. Monitor for AEs, distribute device/study article and monitor device/study articles accountability as appropriate.
> Prepare for and participate in audits by sponsors and external regulators.
> Patient/family interaction - utilize effective communication skills; incorporate specific age, cultural or developmental needs.
> Assist in budget preparation; plan and implement study protocols with regulatory division.
> Protect subject confidentiality.
> Complete tasks and projects by deadlines set by supervisor.
> Investigate solutions to problems and determines best course of action.
> Work effectively in a team environment.
> Perform all other duties as assigned, which may include assisting in other departments.
REQUIREMENTS/QUALIFICATIONS
Minimum 2 years of clinical research experience preferred.
- Excellent interpersonal and professional skills to work effectively with others and provide superior customer service to patients/subjects and their families.
- Ability to handle confidential matters; adheres to all HIPAA guidelines/regulations.
- Understands medical terminology, procedure codes and diagnosis codes as it applies to recruiting subjects for Research.
- Communicates clearly and professionally, both orally and in writing with patients, team members, physicians,
payers, and office coordinators. Knowledge of spelling, punctuation, grammar, sentence structure, and proper English usage
Ability to multi task duties, prioritize work load, organize files and work space and be self-directed in an open office setting.
- Strong proficiency in: MS Office Suite, including Word and Excel, Outlook or other email system, use of computerized medical tracking systems, use of insurance websites, internet search capabilities and other applications as appropriate.
- Strong analytical and problem solving skills.
RELATIONSHIPS
Reports to: Research Manager
Directly Supervises: Not applicable
Work Schedule: Varies, but typically Monday through Friday. Potential for Saturday work hours depending on workload.
FLSA Status: Non-exempt
WORKING CONDITIONS:
> Minimal physical activity (standing, bending, sitting, walking, pulling and lifting) for most of the work shift.
> Clean office environment.
> Possible hazardous chemicals.
If you need assistance with this application, please contact
EyeCare Partners is an equal opportunity/affirmative action employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Please do not contact the office directly – only resumes submitted through this website will be considered.
