Location: New Haven,CT, USA
**Clinical Customer Service Specialist (Contract)**
New Haven, CT, United States Contract (18 months) Published 5 months ago GCP ICH Patient Intake BLS Healthcare Spanish LPN clinical experience Nurse clinical trials **Clinical Customer Service Specialist**
Training will be onsite, then remote until COVID19 restrictions are lifted
**Summary:**
The Clinical Customer Service Specialist 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 with regulatory requirements related to the protection of volunteers confidential data
**Responsibilities:**
* 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 the 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).
* Contact 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 the 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 a positive attitude to the subject population to ensure subjects trust in clinical research
* Support Clinical Trials (under the 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 for problem solving and execution of the protocol
* Document individual subjects participation while involved in study activities
* Responsible for recording study data, maintaining source documentation, and updating the 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 Pfizer 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:**
* Registered Nurse, Licensed Practical Nurse, or related discipline, required
* Bachelors degree strongly preferred
* Healthcare practice experience/training with a valid license preferred
* BLS certification
* Minimum of 3+ years experience in a clinical setting required
* 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
**Shift and Hours:**
* Shifts will vary (candidate must be available for any shift):
* Monday-Friday
* 7:30a-4:00p
* 8:30a-5:00p
* 10:00a-6:30p
* Saturdays (once a month)
* 9:00a-2:00p
**Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.**