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| Senior Clinical Trials Associate - Job # 1938 |
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Client Synopsis:
Full Scale Solutions is currently recruiting for the following position located in Bethlehem PA.
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Essential Duties and Responsibilities:
This incumbent will act as the lead monitor of clinical study sites performing clinical trials and as the sponsor, he/she will oversee the activities of other clinical trials associates to perform monitoring on a study-wide or project-wide basis. Travel to field sites to supervise and coordinate clinical studies. Create and maintain all study related work materials such as Informed Consent Forms (ICFs) monitoring plans, etc. Create and maintains tracking tools for management of site-level activities including subject enrollment, monitoring visit conduct, data collection, and site close-out activities. Some protocol drafting may be will required and the review, maintenance of all clinical protocols and study documents will be required. In conjunction with other staff members, this position will act as liaison between clinical operations, internal departments, and vendors including contact research organization personnel as required.
Other duties include:
- Clinical study site monitoring through travel to clinical sites for review of protocol compliance, individual subject source documents and data collected (source data verification), clinical site regulatory and other documentation compliance according to corporate SOPs. Field monitoring on-site at clinic sites is mandatory.
- Pre-Study Site Visits for site selection (PSSV).
- Site Initiation Visits (SIV) and qualification visits.
- Interim Monitoring Visits (IMVs).
- Close Out Visits (COVs).
- Prepares monitor reports, and follow-up letters to clinical sites in a timely manner.
- May assume delegated supervisory responsibility from the Manager for execution of monitoring and trial master file (TMF) documentation activities supervising other full-time or contracted personnel.
- Trains monitors on protocols, SOPs, and study-specific guidelines.
- Review trip reports, and performance metrics of study monitors. Create mitigation plans if required to assure timely completion of study monitoring tasks.
- Co-monitors clinical sites with company or contracted monitors for quality management as well as workload management.
- Participates in inspections by FDA and Notified Bodies.
- Conduct feasibility assessments for trial design.
- Recruit potential investigators.
- Clinical site activity management to include operational planning for site selection, budget negotiation, study start-up, recruitment and enrollment, clinical document technical writing (trip reports, site instructions, other work instructions as required. Prepares reports for clinical trials and management as directed.
- Enforces and ensures adherence to GCPs of all clinical sites, applicable regulations and internal quality system requirements.
- Training of clinical sites regarding investigational and approved assay systems, GCP conformance.
- Assist with generation of clinical portions of regulatory submission documents.
- Ensures clinical sites operate compliant to FDA Quality System Regulations and Good Clinical Practice Regulations.
- Solve problems encountered at clinical sites or internally during a study Monitors clinical study portion of project adherence to Design Controls SOP.
- Creates study specific documents essential for the conductance of the trial.
- Participates in preparation of regulatory submission responses to FDA inquiries.
- Handles customer / study subject inquiries and advises internal personnel on technical issues and performance of clinical studies.
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Requirements
- Bachelor of Science level education, preferably in a scientific or medical discipline (due to technical expertise required for the job). Courses in immunology and statistics helpful.
- Training in GCP and GLP, EU Harmonized Standards, ICH Guidelines.
- 4+ years experience in clinical trial monitoring.
- Supervisory experience helpful.
- Must be able to travel locally, within the domestic U.S, and possibly internationally for extended periods of time (typically up to one week away from the office; international trips may be longer). Travel is estimated to be approximately 30% over the year, but may be higher either for specific periods or in general dependent upon workload up to 50-60%.
- Knowledge of Code of Federal Regulations, Good Clinical Practices, misc. FDA guidelines pertaining to medical devices, biologics, and clinical trial administration.
- Knowledge of EU Harmonized Standards and ICH guidelines for performance of clinical studies.
- Knowledge of clinical study design.
- Proven ability to direct and manager subordinates.
- Outstanding organizational and time-management skills.
- Ability to effectively communicate orally and in writing at all corporate levels (subordinates, peers, executive management) as well as outside the company.
- Ability to interact with clinical laboratories on a technical level.
- Project management skills.
- PC Skills.
- Multi-tasking skills.
- Cognitive abilities.
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Core Competencies
- Agility
- Analytical Skills
- Innovation
- Integrity
- Planning and Organizing
- Problem Solving
- Quality
- Teamwork
- Managing People
- Project Management
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 For confidential consideration please submit a resume and salary history to
claire@fullscalesolutions.com.
Full Scale Solutions is an Equal Opportunity Employer.
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