Clinical Research Coordinator

As a Clinical Research Coordinator, you will be working in a small, fast-paced environment. You'll assist the Principal Investigator and Research Manager or Research Director with research activities to advance the organization's goals of advancing medical research. The ideal candidate will be passionate about medical research and possess strong project management skills. The right candidate must be highly driven , self motivated and eager to work both independently as well as part of a dynamic team.

The position is open to candidates who are currently resided at or near the job location or planned to move to job location before or on start date. We do not provide relocation assistance.

Responsibilities:

• Facilitates and Coordinates the daily clinical trial activities.
• Screen, recruit and enroll patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
• Fulfill all requirements and procedures set forth by study lab manual, study reference manual.
• Knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during informed consent process.
• Trains study subjects in their responsibilities (i.e. subject diary completion, and dosing of study product(s)
• Ensures study related laboratory reports and patient results are reviewed by the investigator in a timely manner.
• Keeps track of protocol amendments , clarification letters, study updates and implement updates accordingly.
• Attend Investigator meetings requiring travel and report pertinent information back to the research team members .
• Coordinates and facilitates monitoring visits.
• Creates and maintians study source documents
• Report and document AE and SAE's following protocol and site's SOPs.
• Completes all training and study modules assigned per study in a timely manner.
• Performs study procedures including vital signs, ECGs, Phlebotomy.
• Performs specimen processing and shipment of biological specimen duties.
• Maintains drug accountability, logs and inventory of study products and supplies throughout the study .
• Maintains Subject logs throughout the study (Screening logs, enrollment logs, Subject ID logs etc) assisting with regulatory documents as needed.
• Completes case report forms. Extract data from patient charts in a timely manner.
• Enter study data into EDC system, following eCRF study guidelines
• Respond to data clarification requests and queries in a timely manner.
• Schedules study participant appoinments and serves as the patient liaison to the PI and other participating physicians.

Skills and Qualifications:

• High School Diploma or it's equivalent; College degree preferred, Foreign Trained Physicians, LVN/LPN, Relevant BS in Health Sciences
• Two(2) to three (3) years of experience OR certification as a Clinical Research Coordinator
• Able to communicate with providers, co-workers, sponsors and others in a collaborative and courteous manner.
• Knowledgeable in medical terminology as to communicate with physician office and study patient
• Demonstrate the initiative to act independently , initiating activity as required and making appropriate decisions with the constraints of study protocols, regulatory requirements, and company's policy.
• Requirements:
• Excellent communication skills (Interpersonal, written and verbal)
• Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry