Description
DescriptionSupports all aspects of the design, planning, and implementation of clinical research projects. Participates in and coordinates the protocol and final clinical study report writing efforts. Supports conduct of pre-study, initiation, and interim clinical study monitoring visits. Coordinates activities of clinical site to ensure compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. Periodically travels to field sites to supervise and coordinate clinical studies. Assists in drafting clinical study protocols.
Responsibilities
Works on complex problems in which analysis of situations or data requires in in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Conducts pre-study, initiation, interim monitoring of a clinical study. Responsible for site communication and problem solving. Responsible for collection and review of site's essential documents. Ensures compliance with ICH and GCP prior to shipment of clinical supplies. Designs Case Report Forms (CRFs). Creates project specific tools, instructional manuals, protocol and model consents. Involves 10-20 % travel as required to clinical sites to perform study monitoring, including drug accountability, regulatory document review and other related tasks. Manages project objectives to meeting timelines and deliverables. Maintains a budget planning system to track specific and defined clinical projects goals and deliverables across multiple programs. Manages all aspects of documentation on department database/team rooms. Effectively maintains the clinical trial filling system for all studies. Assists with the maintenance of a device/drug inventory system and tracks distribution of clinical supplies to site or third party packager. Coordinates and assists in review and approval of labels for clinical product(s). Maintains project documents, i.e., confidentiality agreements, clinical consultant agreements and service agreements. Assists with the coordination and meeting logistics for clinical advisory, consultant, or expert meetings.
Requirements
A Bachelors degree in a scientific discipline is required. RN or BSN degree is highly desired. Equivalent experience may be accepted. A minimum of 5 years experience in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. A good understanding of FDA regulatory, ICH, GCP and GMP requirements is required. Must be willing to work as part of a team. Must have demonstrated good interpersonal skills. Good computer skills are required. Working knowledge of MS word, Excel, Power point, Lotus notes is a plus.
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