Clinical Research Coordinator

Research Coordinator Experience Required **

Purpose:
Plan, direct, or coordinate Clinical Research projects. Direct the activities of subjects and workers engaged in Clinical Research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data. Recruit and enroll research subjects into clinical trials. Assist in managing advertising for clinical trials.

Tasks

• Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Participate in preparation and management of research budgets and monetary disbursements.
• Confer with health care professionals to determine the best recruitment practices for studies.
• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Direct recruitment activities to meet enrollment goals for research studies
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Participate in the review and development of study protocols including guidelines for administration or data collection procedures.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Order drugs or devices necessary for study completion.
• Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
• Communicate with laboratories or investigators regarding laboratory findings.
• Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

• Code, evaluate, or interpret collected study data.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Document subject adverse events and notify investigators of the adverse events within the timelines required by the research studies and government regulations. Report the adverse events to the CRO and study sponsors as required by the research protocol and within required study timelines.
• Respond to queries from CRO, study monitors, IRB and government regulators within the required timelines.
• Maintain confidentiality of the protocols and subjects

Education:
Bachelor's Degree

Experience:
2 years’ experience

Knowledge:
Medicine and Dentistry - Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Administration and Management - Knowledge of business and management principles involved in strategic planning and coordination of people and resources. Knowledge of Good
Clinical Practice (GCP), government regulation of research (FDA and ICH), Institutional Review
Boards (IRB), Contract Research Organizations (CRO) as well as research sponsor requirements.

Complex Problem Solving Skills

• Complex Problem Solving- Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

Technical Skills

• Equipment Maintenance - Performing routine maintenance on equipment and determining when and what kind of maintenance is needed.
• Understanding and then teaching research subjects how to use technical equipment

such as epro devices and electronic diaries.

• Performance of EKG, spirometry , Phlebotomy and other medical procedures as required by the research study protocols
• Knowledge of multiple research computer programs including clinical trial management systems such as Realtime, electronic data capture systems such as

Medidata or Inform as well as general office programs such as Microsoft Word and Excel.

Work Context

Communication

• Contact With Others
• Electronic Mail
• Face-to-Face Discussions
• Letters and Memos
• Telephone

Tools and Technology

Tools
Electrocardiogram, Spirometry and other medical equipment
Digital camcorders or video cameras

• Digital video equipment

Technology
Analytical or scientific software

• Data analysis software
• Electronic data capture EDC software
• Electronic Data Capture such as Inform, Phase Forward
• Qualitative analysis software

Data base user interface and query software

• Clinical data management system CTMS software
• Database software
• NextGen Office

Electronic mail software

• Email software
• Microsoft Outlook

Word processing software

• Microsoft Word
• Word processing software

Job Type: Full-time

Pay: $50,000.00 - $82,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift

Ability to Relocate:

• Columbia, MD: Relocate before starting work (Required)

Work Location: In person