The Oakland Hills Dermatology is seeking an experienced, positive, highly motivated, organized, autonomous individual with excellent communication and multi-tasking skills to join our growing research team. The Clinical Research Coordinator will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of Dermatology clinical research studies.
Responsibilities
The Clinical Research Coordinator position’s responsibilities include, but are not limited to the following:
- Screen, recruit, provide informed consent, and enroll participants according to protocol for clinical studies.
- Schedule and coordinate participants study visits or work with outpatient scheduler to set-up study visits.
- Directly interact with subjects in a clinic setting including subject interviews, administering survey instruments, etc as per protocol requirement.
- Track and monitor participants’ condition and test results during the course of clinical studies. Relay relevant results to he clinical team.
- Collect and record participant’s study-related data.
- Collect, process, label, store, and ship bio-specimens for clinical studies.
- Ensure all study related documentation is completed accurately with quality and in a timely fashion per sponsor requirements. Can perform data entry into both electronic (EDC) and paper case report forms.
- Manage regulatory requirements including IRB submissions. Management of collection of essential regulatory documents, execution of study protocol, and preparation for sponsor monitoring visits, site initiation and closeout visits.
- Perform medical chart reviews.
- Design source documents, recruitment materials, and other relevant study documents for clinical studies if needed.
- Participate in recruitment strategy meetings to enhance subject awareness of studies and boost subject participation.
- Attend investigator meetings as a study team member.
- Attend training at sponsor site(s) or during investigator meetings.
- Perform general office and administrative duties related to clinical studies.
- Other duties deemed necessary to maintain the smooth operation of Dermatology clinical studies.
Required Qualifications*
- High school diploma, college degree, or equivalent experience in a health science discipline.
- Professional demeanor and excellent interpersonal and communication skills.
- Experience with Microsoft Office products (i.e. Microsoft Word, Excel, and Power Point)
- Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
- Outstanding organizational skills with meticulous attention to detail.
- Strong ability to work independently, exercising good judgement, with minimal supervision.
- Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner.
- Strong problem-solving skills.
- Ability to adhere to established timelines to accomplish tasks.
- Demonstrated ability to learn and use new skills quickly and effectively.
- Able to maintain data confidentiality and participant/subject/patient privacy.
- Excellent attendance record and strong work ethic.
- Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations
Desired Qualifications
- Bachelor’s degree in a health science discipline preferred.
- Experience at Dermatology practice preferred.
- At least 1-2 years’ research experience with federally-sponsored and/or industry-sponsored clinical studies, including direct interaction with patients in a patient care setting or outpatient clinic.
- Strong experience using Research Regulatory Management system.
- Experience with Electronic Data Entry/Capture (EDC).
- A working knowledge of medical terminology and assessment of laboratory values.
- ACRP or SOCRA certified.
- ICH-GCP certified through CITI, HIPAA, and PEERRS training complete and up-to-date.
Job Type: Full-time
Pay: From $20.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
