CLINICAL POSTINGS
| Title | Location | Posting Code |
| Clinical Research Associate | Miami, FL | 3027735 |
| Clinical Customer Service | Miramar, FL | 3027738 |
| Job Title: | Clinical Research Associate |
| Category: | Exempt |
| Posting Code: | 3027735 |
| Location: | Miami, FL |
| Relocation: | Eligible for relocation assistance within country |
| Job Type: | Contract |
| Shift: | 1st |
| Purpose: | Work with the Clinical Research Manager to satisfy applicable regulatory standards and Client's internal requirements for clinical studies |
| Summary of Major Responsibilities: | Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies. May assist in preparation of sections of the Investigational Plan for assigned clinical studies. Assist in preparation of study materials and/or training (e.g., training of investigators, site staff and Client's field staff). Interface with, and assure training of investigators, site staff, and Client's clinical staff. Assist in site initiation (e.g. start-up document preparation, distribution, receipt, and review). Set-up and maintain accurate study status and implant logs. May interface with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups). Assist in preparation of study budget and project plans. May arrange conference calls, staff meetings and training events. Assist in compilation and review of adverse event information. Assist in coordinating field staff activities with clinical site needs. Assist in follow-up and resolution of site issues noted by field staff. Assist in compilation, review and conclusion of device complaints. Assist in study closure activities (e.g. close-out document preparation, distribution, receipt and review, audit and archive). Assist data management group with review of clinical data/information and oversight of data correction. Assist in preparation of annual, interim and final reports and presentations. Assist in control of device allocation, distribution and reconciliation. May assist with oversight of activities performed by Contract Research Organizations (e.g. CROs, core labs). May act as Clinical Affairs representative, interfacing with representatives from other key functional groups including Research and Development, Regulatory Affairs, Manufacturing, Sales, Marketing, Legal and European Clinical Groups. May provide work direction to Clinical Research Assistant(s). May provide work direction to Clinical Monitors to ensure compliance with the Investigational Plan and appropriate regulations, guidelines and policies. Able to refer to Standard Operating Procedures (SOPs) and Department Operating Procedures (DOPs) for guidance on everyday study tasks. Contribute to ongoing SOP development and review. Participate in training to enhance knowledge base. |
| Summary of Major Requirements: | Bachelor’s degree (technical or non-technical). Technical degree defined as engineering, life sciences or related medical/scientific field. Basic knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. Technical degree preferred. Minimum 3-5 years experience directly supporting clinical research or relevant experience in medical/scientific area. Masters degree will substitute for 1 year of experience. PhD or MD will substitute for 2 years of experience. Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology. Computer skills (MS Office products, word processing, spreadsheets, etc.). High attention to detail and accuracy. Ability to manage multiple tasks. Good prioritization and organizational skills. Excellent problem solving skills. Positive outlook. Flexible and dependable. Works effectively on cross-functional teams. |
| Job Title: | Clinical Customer Service |
| Category: | Non-Exempt |
| Posting Code: | 3027738 |
| Location: | Miramar, FL |
| Relocation: | No Relocation Assistant Available |
| Job Type: | Permanent Full Time |
| Shift: | 1st |
| Purpose: | Act as client in house liaison to customers, physicians, sales representatives, and internal management conducting customer service duties. |
| Summary of Major Responsibilities: | - Processes
orders, prepares correspondence, and fulfills customer needs to ensure
customer satisfaction. Has knowledge of commonly-used concepts,
practices, and procedures within clinical research. Relies on
instructions and pre-established guidelines to perform the functions of
the job.
- Answer telephones,
greet visitors, direct calls and visitors to appropriate party |
| Summary of Major Requirements: | Requirements Knowledge/Education: High school diploma or equivalent. Systems knowledge: Microsoft applications, Email, Internet Job Experience: 2 years clinical customer service, order entry, and/or call center experience (1 year with BA/BS degree) Skills/Competencies · Strong interpersonal skills – ability to communicate effectively using both written and verbal communication with diverse groups at all levels · Team-oriented, yet able to work independently · Positive and professional manner · High degree of organization and prioritization skills · Ability to achieve on-going results and process improvements through analysis · Flexible schedule may be necessary Physical Requirements · Sitting 90% of the time · Telephones approximately 90% of the time Preferences: Knowledge/Education: · BA/BS Experience with invoicing, pricing, payments, contracts, etc. Skills/Competencies · Strong leadership skills · Inventory and asset management experience |
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