Clinical Research Assistant

Purpose:

Assist in the performance of Clinical Research projects. Assist with the activities of subjects and workers engaged in Clinical Research projects to ensure compliance with protocols and overall clinical objectives. Help to recruit and enroll research subjects into clinical trials. Assist in managing advertising for clinical trials. Assist research coordinators and research investigators in performing Clinical Research studies.

Tasks

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

• 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.

• Perform phlebotomy under direction of study coordinators,

• Process research samples including blood and urine samples and properly package them and then ship them as per protocol requirements.

• Complete regulatory documents as required by research protocols

• Enter data into EDC under the supervision of Study Coordinators

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

• Order drugs or devices necessary for study completion.

• Code, evaluate, or interpret collected study data.

• 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.

• Respond to queries from CRO, study monitors, IRB and government regulators within the required timelines under the direction of the Study Coordinators.

• Maintain confidentiality of the protocols and subjects

• Track on a monthly basis which research activities need to invoiced and notify the investigator of these events

Activities

Getting Information

Establishing and Maintaining Interpersonal Relationships

Making Decisions and Solving Problems

Organizing, Planning, and Prioritizing Work

Updating and Using Relevant Knowledge

Communicating with Supervisors, Peers, or Subordinates

Documenting/Recording Information

Processing Information

Scheduling Work and Activities

Interacting With Computers

Evaluating Information to Determine Compliance with Standards

Communicating with Persons Outside Organization

Identifying Objects, Actions, and Events

Training and Teaching Others

Monitoring and Controlling Resources

Coordinating the Work and Activities of Others

Monitor Processes, Materials, or Surroundings

Interpreting the Meaning of Information for Others

Developing and Building Teams

Assisting and Caring for Others

Guiding, Directing, and Motivating Subordinates

Resolving Conflicts and Negotiating with Others

Thinking Creatively

Analyzing Data or Information

Performing Administrative Activities

Judging the Qualities of Things, Services, or People

Developing Objectives and Strategies

Estimating the Quantifiable Characteristics of Products, Events, or Information

Provide Consultation and Advice to Others

Education:

High School Diploma

Bachelor's Degree

Experience:

3 years’ experience

Knowledge:

Medicine - 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 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- Assist in 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 under the direction of Study Coordinators.

• 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

Facsimile machines

• Fax machines

Mobile phones

• Smartphones

Notebook computers

• Laptop computers

Personal computers

• Personal computers

Technology

Accounting software

• Budgeting software

• Microsoft Excel

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: $22.00 - $26.00 per hour

Benefits:

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

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

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

Work Location: In person