- Education: Bachelor's Degree
- Functional Area: Research
- Industry: Biotechnology & Pharmaceuticals
Indicate the primary responsibilities critical to the job.
Subject/Patient Database Maintenance
· SME in database query, ensures all information is entered consistently and correctly so that database is searchable with reliable information
· Assists in development and maintenance of the PCRU subject recruitment capabilities to conduct a broad range of studies
· Assists in the identification, exploration and implementation of new methods for subject recruitment to extend the panel
· May assist in the implementation of recruitment campaigns, including the design, drafting & publication of advertisements in various media.
· Maintain accuracy, accessibility, and confidentiality of volunteer records and reports
· May act as a primary contact person for new potential volunteers, responsibilities include:
- Answering incoming calls from potential volunteers responding to any methods of recruitment,
- Inform them about the unit activity, the overall recruitment process and studies,
- Enters gathered information accurately into the database;
· Must be able to process new requests from different media (Internet platform and others).
· Contacts volunteers already listed in the database for proactive engagement, answers questions about the clinical trial process. Inform potential volunteers on the next steps and/or scheduled appointments and how to reach the clinical research unit.
Recruitment and Screening Activities (overseen by Supervisor)
· Provide support to internal clinical research staff in the pre-selection of subjects for eligibility using protocol inclusion/exclusion criteria;
· Communicate protocol requirements to study subjects and patients calling to inquire about specific studies;
· May create and manage various communication methods to subjects, including but not limited to letters, text messaging, and mailings;
· Manage subject phone calls including scheduling/rescheduling of appointments;
· Responsible for meeting timelines required for filling specific study screenings and for filling cohorts and groups for dosing.
· Provides training to less experienced phone screen staff when needed and demonstrates ability to problem solve.
· Maintains a positive and professional attitude to the subject population, understanding they are the first contact subjects have with the CRU;
· Track phone call metrics from sources of advertising so that advertising strategies can be decided based on what is most effective;
· May write and update recruitment related documents for subject use as appropriate
· Communicate protocol requirements to study subjects and contribute to compliance
· Demonstrate positive attitude to the subject population to ensure subject’s trust in clinical research
Support Clinical Trials (under responsibility of the Principal Investigator)
· Assist in the conduct of clinical trials in the PCRU
· May obtain signed informed consent from candidate trial-subjects
· May assist in staff scheduling as appropriate
· May assist in the data management/cleaning activities for assigned protocols
· Identify new options to problem solving and execution of the protocol
· Document individual subject’s participation while involved in study activities
· Responsible for recording study data, maintaining source documentation, and updating subject database, not only specific to study participation
· Participate in community outreach efforts
· Assist in development and maintenance of social media presence including managing all website updates (managing ads, posting new content etc.)
· Assist in the increase of the unit awareness
· Participate in PCRU teams to accomplish business needs and resolve issues
· Ensure data collection of high quality and transfer to relevant departments
· Ability to take over and manage other specific projects
· Participate in the communication and study related meetings
· Ensure clinical trials are conducted in accordance with scientific, medical, and ethical principles, within regulatory requirements/guidelines, and SOPs
· May participate in the different administrative parts related to the execution of Phase I clinical studies.
· Support ongoing capture and analysis of metrics to demonstrate value and increase productivity
· 40 hour position; includes some weekend and evening hours;
· Represents the PCRU on global initiatives as subject matter expert, as appropriate
· May participate in the communication and study related meetings
· May participate in the different financial matters, including purchasing/orders management, contact with suppliers, budgets set up and management, monthly expenses justification, bank account management, payment of subjects
· May act as a receptionist.
· Supports ongoing capture and analysis of metrics to demonstrate value and increase productivity
· Participates in the creation and implementation of global and local SOPs
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
· Licensed Practical Nurse, or related discipline, required
· Health care practice experience/training with valid license, preferred
· Minimum of 3 years’ experience in a clinical setting
· Bachelor’s Degree strongly preferred
· BLS certification
· Proficiency in using MS Office tools suite (Excel, Word, etc.)
· Understanding of local regulatory requirements (e.g., ICH, GCP)
· Understanding of the drug development process
· Spanish language fluency strongly preferred
· Excellent written and verbal communication skills
· Excellent computer skills
· Excellent customer service and professionalism.
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering.
- Name: Himanshu Kumar
- Email: firstname.lastname@example.org
- Phone: 9525463500
- Extension: 5046
- Name: Select Source International
- Website: www.selectsourceintl.com