Clinical Coordinator

An emerging pharmaceutical company creating new medicines to improve the lives of people with cancer is seeking a Clinical Coordinator located in South San Francisco, CA for a 3 month contract.

 

Job Summary:

 

The Clinical Coordinator will provide support for the clinical operations/development group in the execution and maintenance of clinical study activities, interacting with internal and external resources, including but not limited to the duties described below. The Clinical Coordinator receives minimal supervision and direction on routine work and on new assignments.

 

Responsibilities:

 

- Reviews regulatory documents and initiates follow-up actions (internal and external), as required.

- Manages business forms and works with the CRA/study monitor for appropriate follow-up.

- May assists with site specific informed consent review and processing with sites.

- Reviews protocols, protocol amendments and summary of change documents to ensure internal consistency.

- May assists with CRF reviews.

- Assists with the development of clinical/regulatory, pharmacy and related binders as needed.

- Generates standard reports from CTMS for study/project teams on a regular basis.

- Prepares documents for which Clinical Operations is responsible for central archiving.

- Has a good working knowledge of standard operating procedures (SOPS) and a good knowledge of applicable FDA regulations/guidance and ICH guidelines.

- Has a solid knowledge of basic tasks/activities related to assigned projects/department responsibilities and is able to provide back-up as needed.

- Self-directed in reading related clinical research articles within the therapeutic area and in building his/her own skill base.

- May assist in the development of training tools for databases and routine department/project reports.

- Performs additional duties as needed to support clinical projects.

 

Requirements:

 

- Associates or bachelors degree or equivalent in prior training and experience.

- A minimum of two years clinical/administrative experience.

- Knowledge of GCP, FDA regulations and ICH guidelines.

- Excellent organizational skills and attention to detail.

- Very good written and verbal communication skills.

- Computer skills, including Microsoft Office are essential.

- Independent use of department database and report generations.

- Beginning leadership skills denoted by actively participating in decision-making with teams and departments.

- Ability to interact well on a variety of teams, using good interpersonal communication skills is required.