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

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