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13 days old

Clinical Director

Catalina Research Institute, LLC
Montclair, California 91763
  • Job Type
    Employee
  • Job Status
    Full Time

Catalina Research Institute, LLC is a fast growing, multi-specialty research site in Montclair, California. We are looking for an experienced, detail oriented Clinical Director to join our Clinical Operations Team. The Clinical Director is responsible for executing, managing and closing projects.  Supervises and directs the study teams in the implementation and execution of clinical trials. Directs planning and implements all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed.  Conducts site visits for pre-study, study initiation and study close-out. The Clinical Director manages, executes and reports on clinical study operations and provides leadership and support to members of the multidisciplinary project team, internally and externally.  

ESSENTIAL FUNCTIONS/RESPONSIBILITIES

Responsible for Profit and Loss and overall success of study enrollment.

Responsible for management of the Clinical Investigators.  

Understand and support project goals including site study recruitment, patient recruitment, marketing and PR as appropriate.

Lead the implementation of study specific protocols, consent forms, and other trial related materials as required.

Ensures the appropriate development of all documents by the coordinating staff including but not limited to: study source documents, Study start up sheets, progress notes, subject instruction sheets, study cheat sheets and other project-specific documents required for the conduct of newly awarded and ongoing studies.

Ensure that all GCP, EDC and protocol specific training has been completed by all members of the study team to ensure that studies are launched in a timely manner.

Implement approved clinical study protocols and operational plans, and assumes primary accountability for the ongoing progress of those plans on all assigned studies.

Initiate and train new study teams and ensure proper team adherence to clinical research regulations and study protocols (GCP).

Plans for and manages all materials to support the appropriate execution of the clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational drugs or devises and ensures that supplies are available based on the demands of the trial.

Ensure maintenance of document standardization through the use of model documents, templates and appropriate peer review. Performs final Quality Assurance review to ensure that all documents meet with Sponsor approval and can be utilized for use in the trial.

Ensure maintenance and completion of project files such as Drug Accountability Logs, as per Sponsors expectations and according to applicable regulations, guidelines, (e.g. GCP’s and SOP’s).

Assumes primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, for study activities.

Ensure the development and maintenance of project-specific tracking systems to enable proper study management and monitoring activities as required. This includes study start up materials, ongoing queries and final supplies that need to be returned to Sponsor companies.

Work with Site Regulatory Department to help ensure that internal project team members are trained appropriately to ensure proper study conduct as per the Delegation of Authority Log.

Prepare internal and external memos, reports, documents, and correspondence required to properly manage and document activities on all studies.

Serves as a resource and mentor for Clinical Research Coordinators, Research Assistants, Research Nurses, Phlebotomists, and other Clinical Operations personnel.

Serves as a liaison between Sponsor, Contract Research Organizations and internal team to ensure project specific information and ongoing updates are proactively communicated.

Attends and records notes for end of Monitor meetings to ensure that action items are addressed in a timely manner.

Requirements

Bachelor's degree or higher. 5-8 years related experience to include 4 years in clinical research with at least 3 years of site management.

Must have experience qualifying and managing external vendors (e.g. CRO, Call Center, Central Labs, etc.)

Must have experience managing clinical project teams’ personnel and leading project operational teams through the start-up, study conduct, data management, and final study close-out.

Demonstrates good problem-solving and interpersonal skills.

Excellent organizational and communication skills, including experience interacting with decision makers, such as physicians, Clinical Research Associates and Project Managers.

Ability to work independently and willingness to take ownership and manage multiple projects and timelines while maintaining the team focus.

Ability to frequently and accurately communicate with employees, customers, and vendors in person, via the telephone or by email.

Ability to exercise good judgment and determine appropriate action to a variety of problems of varying complexity.

Understand and support project goals including site study recruitment, patient recruitment, marketing and PR as appropriate.

Ability to manage multiple deadlines.

Categories

Posted: 2020-10-12 Expires: 2020-11-11

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Clinical Director

Catalina Research Institute, LLC
Montclair, California 91763

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