Medical Director

CenExcel HRI is seeking a full-time Medical Director to join our team.

Essential Job Functions:

• Assesses overall protocol feasibility

• Evaluates eligibility of trial participants

• Trains and supervises clinical staff and delegates study assignments to ensure study conduct is compliant with all GCP/ICH, protocol, and FDA guidelines and requirements

• Assesses adverse events and ensures they are reported as required to the sponsor and IRB

• Ensures proper completion and retention of trial documents

• Provides the IRB with adequate information throughout all stages of study conduct

• Ensures that informed consent is obtained from each research subject prior to subject participation in a research study

• Conducts protocol assessments and procedures

• Oversees the dispensing and administration of the investigational product as well as accountability

• Reviews and provides approval for all CRFs/eCRFs

• Reviews laboratory and diagnostic testing results, X-rays, and ECGS

• Participates in monitoring visits and audits, as appropriate

• Attends investigator meetings (when applicable and possible)

• Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, and participating in professional societies

• Other job duties as needed

Knowledge, Education, and Experience:

• MD or DO degree

• Post-doctoral experience and a strong publication record are preferred

• Minimum of one (1) year of clinical research experience as an investigator or sub-investigator recommended

• Displays mastery of Microsoft Office: Word, Excel

• Knowledge of FDA, GCP, ICH, and other state and federal agency guidelines

• Knowledge of the HIPAA Privacy Act and its application to clinical research

• Knowledge of IRB requirements

Skills and Abilities:

• Flexible attitude with respect to work assignments

• Ability to manage multiple and varied tasks in a fast-moving environment

• Ability to interact professionally at all levels within the organization and with clients

• Ability in the administration, and interpretation of protocols as directed by sponsor

• Highly developed verbal and written communication skills

• Demonstrated skill in clinical interviewing

• Demonstrated ability counseling subjects

• Demonstrated skills in consultation and the ability to work as part of a team

Equipment and Materials Used:

• Computer / Laptop / Smartphone

• Telephone

• Fax machine, copier

Physical Tasks:

• Sitting, standing, reaching overhead and lifting up to 30 pounds

• Heavy hand/write movement while using keyboard

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.