Clinical Trials Assistant Jobs in Raleigh, NC (NOW HIRING)

Worldwide Clinical Trials is the cure of the common CRO.  The time is right to join our growing team, consisting of 1,600 talented and dedicated employees from across the globe. We’re doing innovative and exceptional work each and every day. Our team is filled with purpose, as we support our sponsors in the discovery of cures and treatments for diseases affecting millions of people around the world.

If you’re looking to join an energetic and collaborative team that is valued and supported by company leadership, committed to operational excellence and open to creativity and innovation, Worldwide Clinical Trials could be the ideal place for you. We have exciting opportunities in clinical drug development, project management, corporate functions, sales, and more. Explore current openings and learn more about Worldwide’s culture below.

We are looking for a Sr. Medical Director to join our team.  This Cardiologist will provide medical management and professional medical support for clinical research projects at WCT as the assigned Medical Monitor (MM). To assist in activities requiring Medical & Scientific support, including but not limited to: assistance with feasibility assessments, medical training and provision of medical/clinical input to the design of study protocols and/or clinical development programs as well as assistance with business development activities, as directed by the department head.

RESPONSIBILITIES:

Tasks may include but are not limited to:

 Medically manages clinical trials to which s/he is assigned as MM

 Serves as Global Lead MM (GLMM) for pan-regional and/.or global trial(s) to which s/he is assigned

 Collaborates with the other members of the Medical & Safety project team to process Serious Adverse Events (SAEs)

US: when contracted might conducts and document an Analysis of Similar Events (AOSE) included as part of the case narrative, in keeping with FDA 21CFR312.32

 Provides therapeutic and protocol-specific training to the project teams

 Contributes medical input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc

 Provides after hours medical support for projects to which s/he is assigned

 Independently supports Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management

 Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,) as directed by senior management

 Maintains a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments by participating in internal meetings (company-wide project tracking, medical management meeting, etc) , review of relevant therapeutic/clinical literature and attendance in conferences and meetings

 Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects

 Identifies, documents and appropriately resolves out-of-scope work as directed by senior management

 Assists in the annual attainment of departmental revenue targets and any other activities as directed by senior management

 Maintains working knowledge of GCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards

 Mentors other medical staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, support Senior Management’s leadership of both the department and the company.

REQUIREMENTS:

 Customary office desk and managerial work, no heavy lifting, occasional business travel

 Medical Degree from an accredited institution of Medical Education.

 6-8 years clinical research or industry experience