JOB TITLE: Clinical Study Coordinator
Coordinate and participate in clinical research studies conducted by principal investigator(s) at Mercury Clinical Research, Inc. Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data.
Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.
- Effective negotiator and decision maker. Knowledgeable and confident in management
- Well-organized, thorough in the protocols of human research and data collection
- Able to deal with sensitive populations in a professional and conscientious manner
- Skilled in refining and translating researcher’s objectives
- Completes study start-up regulatory submissions like site questionnaires, P.I. CV’s, financial disclosures, form 1572 including completion of training requirements such as HAZMAT, sponsor specific training modules and eCRF training courses.
- Attend investigator meetings when needed, web conferences and teleconferences.
- Screens subjects according to protocol inclusion/exclusion criteria.
- Explains informed consent specific to protocol to potential enrollees, answers questions if any, and documents the informed consent process.
- Draws blood when needed, process and ships specimen according to sponsor requirements including vital signs, EKG and radial augmentation index studies.
- Completes visit procedures according to protocol schedule and checks on visit measurements, lab results, concomitant medications and presence of adverse events.
- Completes source documents and enters the same in the CRF or eCRF.
- Works closely with sponsor monitors during site initiation visits, site monitoring visits, and answer queries when needed.
- Completes drug accountability records, dispenses study medications per protocol requirements or through the IVRS.
- Miscellaneous duties such as keeping records of temperature logs of drugs storage and freezers.
- Completes study close out visit by proper drug accountability and shipment of used and unused study medications.
- Responsible for IRB submissions, SAE reporting, continuing approval reports.
- Maintain Trial Master Files & document according to Regulatory Retention Requirements.
- Document all of the above in a timely manner.
Education: Certificate from accredited Medical Assistant Program. High School Diploma or GED program. Additional clinical certification is a plus.
Experience: Work requires one year experience in research or a clerical setting to become familiar with the basic techniques and methods used to collect, compile, verify and store information.
Knowledge, Skills, and Abilities: Work requires the ability to understand and follow oral and written instructions generally acquired through a high school education and medical assistant programming.
Working knowledge of clinical trail procedures that are applicable to work performed.
Working knowledge of procedures and techniques in administering routine and special treatments to clinical research study patients.
Able to document and communicate pertinent information.
Ability to establish and maintain effective working relationship with clinical research study patients and clinic staff.
Open positions for the following sites: