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Medical Director

 

JOB SUMMARY

The Medical Director (MD) designs, implements, and monitors clinical studies of compounds and devices designated for clinical development. The MD is responsible for the recruitment, screening, and selecting of competent investigators. He/she will fulfill the role of Principal Investigator (PI) or Sub-Investigator (Sub-I) as the studies dictate. The MD is responsible for ensuring that the protocol is conducted to plan and to all applicable Federal Regulations.

ESSENTIAL JOB FUNCTIONS

1. Primary

Represents WCCT Global as the primary MD/DO overseeing clinical issues at WCCTG-owned sites

Plans clinical programs and develops a timetable, budget, and resource analysis for clinical programs and personnel administration

Establishes and maintains relationships with alliance partners, external companies, Investigators and opinion leaders to optimize performance on clinical trial activities

Provides MD input for study feasibility and client visits

Collaborate with Business Development, Project Management, Clinical Operations, Data Management/Statistics, and Sponsor to determine study timelines/study conduct

Assures that Good Clinical Practice (GCP) is followed

Assures timely completion of studies

Writes clinical reports upon completion or termination of studies (in cooperation with statistical staff)

Responsibilities include, but are not limited to:

Recruiting, screening, and selection of competent Investigators

Organizes Investigators’ meeting and internal training

Manages Investigator schedule at WCCT Global-owned sites

Hire Physician Investigators or Physician Extenders (PA or NP) as the company’s needs grow

2. General

Responsible for protecting the rights, safety, and welfare of all Subjects under the Investigator’s care

Provide both emergent and non-emergent Medical Care: When in the facility, the MD will respond with the Emergency Response Team when a code is called

Explain in detail informed consent forms to potential Subjects: Administer consent per SOP guidelines

Sign off on any protocol deviations

Responsible for performing procedures such as, but not limited to: Initial dosing, Physical Exams, Review all safety labs and EKG’s. AE and SAE assessments

3. PI

Responsible for the control of investigational product

Responsible for the control of non-study drugs within the facility

Thoroughly understand all assigned protocols and study procedures

Responsible for discussing any medical or protocol issues with the medical monitor

Sign off on any protocol deviations

Responsible for performing procedures such as, but not limited to: Initial dosing, Physical Exams, Review all safety labs and EKG’s, AE and SAE assessments

4. Sub-I

Assist the PI in the control of investigational product

Assist the PI in the control of non-study drugs within the facility

Explain in detail informed consent forms to potential Subjects: Administer consent per SOP guidelines

Thoroughly understand all assigned protocols and study procedures

Under PI guidance, discuss any medical or protocol issues with the medical monitor

5. Leadership

Responsible for oversight of WCCT Global Physicians, NPs, and PAs

Follow established SOPs for the oversight and management of data collection, Subject safety, and clinical research staff

Provide oversight of all studies WCCT Global-owned sites to ensure protocol driven direction and completion.

Promote a positive team-oriented interaction between departments

6. Training

      Primary

Update/Revise WCCT Global Training Tracks as needed

Update and/or develop SOPs as required

Coordinate activities as it relates to operations and actively participate on subspecialty committees, corporate committees, and business unit committees

Provide Investigator training for PIs

Provide and/or coordinate training for recruitment and operations teams

Provide and/or oversee ACLS< PALS< and BCLS training for the medical staff

      PI

Ensure staff has adequate training and understanding of the clinical trial and study procedures to complete the trial correctly

      Sub-I

Assist the PI in ensuring staff has adequate training and understanding of the clinical trial and study procedures to complete the trial correctly

7. Other Duties

      General: on-call for any after-hours safety-related events, Participate in developing recruitment goals and strategies, perform other related duties as assigned by supervisor and incidental to the work described herein

      PI: attend and participate in weekly feasibility meetings (as applicable), actively participate in pre-study meetings, initiations, and Investigator meetings

      Sub-I: Participate in pre-study meetings, initiations, and Investigator meetings (as needed)

EDUCATION, CERTIFICATES, LICENSES AND TRAINING

Education

1. Current California license as a MD/DO

2. Board Certification recommended

3. Current American Heart Association Basic Life Support (BLS) Certification required

4. Current American Heart Association Advanced Cardiac Life Support (ACLS) Certification required

5. Current American Heart Association Pediatric Advanced Life Support (PALS) Certification strongly recommended

Experience/Training

1. Minimum of 5+ years’ experience in clinical research

2. Clinical research trials experience is preferred

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