Regional Clinical Research Associates

Scope of the Job:

Positions located around the country. Your basic role is the overall coordination and management of clinical research projects in conjunction with the project team.

You may be responsible for management of multiple protocols, provide monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations and company procedures. You will assist with preparation and presentation of marketing proposals; oversee training of site personnel and project teams as appropriate, including mentoring of CRAs. You must have demonstrated leadership skills and ability to manage, motivate, and integrate a team.

Job Duties and Responsibilities:

· Works as part of the Project Team to contribute towards efficient management of the project.

· Responsible for all aspects of study site management to ensure quality of data generated by managed sites resulting in consistently low query levels and manage sites resulting in acceptable Quality Assurance reports.

· Duties include prestudy, initiation, routine monitoring and closedown of clinical sites, maintenance of study files.

· Establish, update, track and maintain study specific trial management tools/systems.

· Prepares accurate and timely trip reports.

· May contribute to the design of clinical trial protocols, case report forms and other study documentation in collaboration with project managers.

· May negotiate study budgets with potential investigators and assist legal with grant agreements.

· Tracking of Clinical trial supplies.· Assists with recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the PM/LPC.

· In-house review of CRFs and query resolution.

· Full understanding of the SAE reporting process production of reports narratives and follow up of SAEs.

· Develops and maintains good working relationship with investigators and study staff and promotes the Company’s high quality and ethical image.

· May prepare status reports or input into status reports.

· May assist with training and development of new employees, e.g. co-monitoring.

· May assist with review of trial reports.

· May undertake feasibility work when requested.

· May co-ordinate designated clinical projects as a Local Project Coordinator (with supervision if applicable), and may act as local client contact.

·Travel, as necessary according to project needs.

· Perform other duties as assigned by management.

Candidate Requirements:

· We seek a professional with a BA/BS in life sciences or Nursing Licensure or other health-related field ( Nursing/Paramedical qualification or Science Degree). M.S. Preferred.

· Requires 2 -5 years experience in clinical monitoring.

· You must possess excellent oral and written communication skills; ability to develop and lead a project team; people and project management skills; time management/prioritization, resource allocation skills; good customer client relations skills.

· Ability to drive and be available for extensive travel (60% - 80%), including overnight stays.

· You must possess thorough knowledge of ICH-Good Clinical Practice, the Clinical Trial Process, and basic understanding of regulatory requirements gained through previous project management experience.

· Good knowledge of project management techniques and financial control procedures.

· For the best fit, you should be a results oriented leader and team player with demonstrated interpersonal and communications skills capable of working collaboratively with colleagues and investigators. You must be able to work and travel independently.

Compensation

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, and an attractive benefits package.