Clinical Research Coordinator
InterMed | South Portland, ME
You will join a fast-paced, fast-growing leader in healthcare. You will work for the largest physician-owned primary care practice in the state, which has been named one of the Best Places to Work in Maine for 6 straight years.
You’ll work in a patient centered, collaborative and supportive team oriented environment with great people who are passionate about the care they provide. You’ll inspire others by living out our mission, vision and values while using your clinical knowledge and medical expertise to provide exceptional care to our patients.
In this role, you will:
- Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas/ phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols – under the authority of the Primary Investigator (PI)
- Adhere to all institutional and government regulations, maintain accurate regulatory files; assure compliance with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies
- Ensure the smooth and efficient day-to-day operation of research and activities; act as primary administrative point of contact and as principal operational liaison as needed
- Provide administrative support to monitors, investigators and Medical Director
- Preparation of all Regulatory documents and Institutional Review Board (IRB) submissions
- Coordinate and participate in a variety of activities involved in the collection, compilation, and documentation of clinical research data
- Evaluate and interpret collected clinical data in conjunction with principal investigator(s)
What’s required to do this?
- 1-3 years relevant experience directly related to duties and responsibilities required
- Knowledge of FDA Regulation
- Bachelor’s degree desired, preferably in nursing or healthcare
- Successful completion of RN program; unencumbered Maine RN license
- Knowledge of FDA Regulations
- DOT/IATA certification
- NIH or CITI certification
- CPR certification
As an InterMed employee:
- Your work will be acknowledged and appreciated
- You will work with people who are compassionate, empathetic and put patients first
- You will have the opportunity to have your voice heard by joining a committee, task force or work group
- Most importantly, you will be encouraged to have fun while carrying out our mission to serve!
Your benefits will include:
- Up to 8 days of paid time off, plus 6 paid holidays and up to 2 floating holidays
- Choice of two medical plans & dental plan
- Generous employer contribution to participants’ Health Savings Account
- 401 (k) and profit sharing plans
- Employer paid Short- and Long-term Disability coverage
- Opportunity to learn, grow and advance