Position Summary:

 
Assists with 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. Assists with 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. May assist in drafting clinical study protocols.

Responsibilities:

 
Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Assists with pre-study, initiation, interim monitoring of a clinical study.
Assists with site communication and problem solving.
Responsible for collection and review of site's essential documents.
Helps to ensure compliance with ICH and GCP prior to shipment of clinical supplies.
Designs Case Report Forms (CRFs).
Coordinates study-related activities with site and other internal departments.
Assists with the creation of project specific tools, instructional manuals, protocol and model consents.
May involve 10-20 % travel as required to clinical sites to perform study monitoring, including drug accountability, regulatory document review and other related tasks.
Works on project objectives to meet timelines and deliverables.
Maintains the budget planning system to track specific and defined clinical projects goals and deliverables.
Maintains all aspects of documentation on department database/team rooms.
Effectively maintains the clinical trial filling system for studies.
Acts as backup Clinical point person for the JD Edwards MRP system.
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 2 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.
Knowledge 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.