Curis-Controlling Signal Pathways to Modern Health
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Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. In expanding its drug development efforts in the field of cancer through its proprietary targeted cancer programs, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. For more information, visit Curis' website at www.curis.com.

Clinical Operations Specialist:

Curis is seeking a Clinical Operations Specialist to oversee operational activities supporting all clinical studies at Curis.  Reporting to the Vice President, Drug Development, this person must be familiar with all operational aspects of clinical trials, including the planning and execution of assigned trials.  Experience in all phases of clinical trials with emphasis on Phase I and Phase II studies a plus, as is experience in contract initiation and negotiation. This person must have the ability to work independently with limited supervision, making data-driven decisions. 

 

Responsibilities include, but are not limited to:

 

·        Operational responsibility, through a CRO, for aspects of clinical trial activity, including preparation of study protocol and CRF, budget negotiation, investigator selection, study initiation, monitoring, closeout, and report review;

·        Producing, maintaining and monitoring project, development budget plans and timelines;

·        Clinical trial supply ordering and tracking;

·        Working closely with data managers to ensure data retrieval and clean-up is on schedule;

·        Vendor selection and management:  CROs, central labs, clinical trial supply manufacturers and distributors;

·        Maintaining regular contact with personnel at clinical investigative sites and/or CROs;

·        Reviewing and providing input on all necessary study related documents, e.g., protocol, CRFs, informed consent, etc.;

·        Effectively liaising with all participating functional areas that are represented at the clinical trial team;

·        Coordinating and preparing training presentations and/or attending investigator meetings.

 

Requirements:

 

Applying candidates must have a Bachelor’s degree in a scientific discipline or the equivalent, with at least 4-6 years clinical research experience.  Three years of direct monitoring experience is preferred.

 

The ideal candidate possesses knowledge and appreciation of all stages of pharmaceutical drug development, analytical operations, compliance and documentation.  He/She must have demonstrated leadership skills with ability to work in high performance teams.  This position requires excellent knowledge of monitoring practices, demonstrated knowledge/competence in application of CFRs, GCPs, and ICH guidelines.  He/She must possess excellent oral and written communication skills, attention to detail, project management skills, superb organizational and interpersonal skills, and the ability to juggle multiple projects with strict timelines.

 


Job Code: COS500

Qualified candidates should submit their CVs, with job code, via email to jobs@curis.com, via fax to 617-503-6501, or mail to:
Human Resources,
Curis, Inc.
45 Moulton Street
Cambridge, MA 02138   

No phone calls please.
Curis, Inc. is an Equal Opportunity Employer.


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