TeleMed2U is a forward-thinking multi-specialty brand with a mission of brining specialty care to everyone including individuals, providers, and organizations. Our people are our biggest asset who lead the way in making Specialty care more accessible and affordable every day for Americans nationwide. We are an ambitious brand, growing fast to become a household name for Specialty care across the US and constantly need talented people to make it happen. If you are passionate about digital health, helping patients and want to make a difference in healthcare, then considerTeleMed2U as the next chapter in your career.
The CRC will be responsible for the overall coordination, organization and implementation of research studies in compliance with study protocol, SOPs, and state and federal regulations. The CRC will be expected to maintain open, clear, and effective communication with the physicians, patients, study sponsors, Institutional Review Board, and internal management.
Study Execution & Management:
- Successful enrollment and screening of study participants ensuring consistency in data quality and integrity
- Schedule subject visits and coordinate physicians/other staff availability
- Complete and document study visit procedures including: Obtain informed consent; Explain study procedures; Conduct patient interviews; Observe and record anthropometric measurements; Biological sample collection, preparation and shipment; ECG tracing or other diagnostic information collection; Distributing investigational product and other supplies; Scheduling follow-up visits etc.
- Coordinate physician schedule and involvement in clinical research
- Create/update study documents
- Manage study related essential/regulatory documents
- Ensure proper inventory level of study supplies
- Update electronic health records for patients
- Coordinate/schedule sponsor monitoring visits and audits
- Maintain protocol compliance and timeline adherence
Regulatory Compliance:
- Maintain compliance of GCP, HIPAA,OSHA, IATA, InternalSOP, Protocol, state and local regulations as required
- Follow regulation and protocol established for each study
- Regulatory submission for new and existing studies in conjunction with sponsor and IRB requirements.
- Maintain and safeguard the confidentiality of all patient data as well as other pertinent information acquired during the performance of their job duties
- Clean and maintain clinical instruments/equipment as needed, keeping appropriate documentation required by OSHA
Administrative Support:
- Attend project specific training and conduct cross training for other research staff members
- Manage phone calls in a timely and courteous manner
- Provide accurate and timely feedback to physicians, pharmaceutical companies and study participants
- Knowledge and understanding of general medical terminology; clinical methods, procedures, and applications
- Ability to effectively operate the equipment necessary to perform all duties of the job
- Knowledge and understanding of the principals of good clinical practices including ethical issues, patient rights, regulations and guidelines for clinical research
- Proficient with performing general office procedures and the ability to apply these in scheduling patients and adhering to established procedures
- Excellent written and verbal communication skills – must be comfortable and effective in communicating with potential study participants from a diverse population
Competencies:
- Detail oriented – demonstrate a high level of attention to detail
- Problem solving –gather and analyze information skillfully, work well in group to solve problems as they arise
- Customer service – respond promptly and appropriately to customer need
- Interpersonal skills - open to others’ ideas and willing to learn new things; respond well to questions and challenges
- Communication– speak clearly and persuasively in positive or negative situations. Listen and seek clarification when necessary. Write clearly and informatively
- Process improvement – support ideas and theories on process improvement for efficiency and effectiveness
Education & Experience Requirements:
Minimum Required:
- High school diploma or equivalent with at least 6+ months’ previous experience in the medical field as an CMA, LVN, or similar role; or prior research experience.
Preferred:
- At least 1 year of experience in a CMA, LVN, medical office, or similar role a strong plus
- Previous experience in medical research a strong plus
- Working knowledge of research methodology, medical terminology, and pharmacology
- CPR/AED Certification
- CCRC Certification a strong plus
Position Type/Expected Hours of Work:
This is a Full time Salary position Monday through Friday with Work hours varying between the hours of 7:00AM – 6:00PM, depending on study requirements and agreement upon hire.
