Clinical Trial Administrator I

Tasks

• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.

• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.

• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.

• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.

• Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• 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, or potential subject risks.

• Code, evaluate, or interpret collected study data.

• Participate in preparation and management of research budgets and monetary disbursements.

• Participate in the development of study protocols including guidelines for administration or data collection procedures.

• Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.

• Communicate with laboratories or investigators regarding laboratory findings.

• Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

• Order drugs or devices necessary for study completion.

• Confer with health care professionals to determine the best recruitment practices for studies.

• Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

• Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.

• Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.

• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.

• Inform patients or caregivers about study aspects and outcomes to be expected.

• Direct the requisition, collection, labeling, storage, or shipment of specimens.

• Register protocol patients with appropriate statistical centers as required.

• Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

• Arrange for research study sites and determine staff or equipment availability.

• Contact outside health care providers and communicate with subjects to obtain follow-up information.

• Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.

• Solicit industry-sponsored trials through contacts and professional organizations.

• Organize space for study equipment and supplies.

• Develop advertising and other informational materials to be used in subject recruitment.

Skills

• Reading Comprehension - Understanding written sentences and paragraphs in work related documents.

• Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

• Writing - Communicating effectively in writing as appropriate for the needs of the audience.

• Speaking - Talking to others to convey information effectively.

• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

• Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.

• Monitoring - Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

• Social Perceptiveness - Being aware of others' reactions and understanding why they react as they do.

• Coordination - Adjusting actions in relation to others' actions.

• Persuasion - Persuading others to change their minds or behavior.

• Negotiation - Bringing others together and trying to reconcile differences.

• Instructing - Teaching others how to do something.

• Service Orientation - Actively looking for ways to help people.

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

• Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.

• Time Management - Managing one's own time and the time of others.

• Management of Personnel Resources - Motivating, developing, and directing people as they work, identifying the best people for the job.

Knowledge

• Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

• 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.