Job Title: Clinical Trials Associate - I
Location: New Haven, CT 06511 (Hybrid)
Duration: 18 Months

JOB SUMMARY
Summarize the primary purpose & key accountabilities of the job.
The Volunteer Recruitment Support assists the colleagues working in the Business Operations department for all recruitment related activities of trial subjects:
• Database development and maintenance, pre selection of suitable study candidates, organize recruitment related activities pre-, per- and post study. Supports clinical trials by drafting/using different recruitment related documents, performs administrative activities
• Contributes to compliance of regulatory requirements related to the protection of volunteer’s confidential data
 
JOB RESPONSIBILITIES
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
 
Other
• 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 company 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.
• Registered Nurse, 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 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 28.23/hr.