Contractor Medical Director
Location: San Antonio, Texas, United States
Requisition Number: 1414
Position Title: Medical Director - Investigator
SUMMARY: Ensures adherence to protocol requirements, protects the rights and welfare of subjects, assures the integrity of data generated at the site, and directs the conduct of the clinical investigation according to federal and state regulations and guidance documents. The Vice President, Medical Director, Investigator works under the direct supervision and guidance of the Executive Vice President/General Manager. Directly supervises all full time, part-time, and PRN Investigators and Sub-Investigators. Indirectly supervises and oversees all clinical staff.
Tasks may include but are not limited to:
- Ensures protocol compliance:
- Possesses a thorough understanding of the requirements of each protocol,
- Determines whether inclusion/exclusion criteria apply to the study population,
- Ensures recruitment goals are reasonable and attainable,
- Assesses overall protocol feasibility,
- Follows the trial’s randomization procedures,
- Maintains protocol compliance and does not implement any protocol deviations or changes without agreement by the sponsor and prior review and approval by the IRB (except to eliminate immediate hazards to the subject),
- Reviews the inclusion/exclusion criteria, schedules visits, endpoint criteria, and investigational article use with the research team.
- Supports review by a duly constituted IRB:
- Provides the IRB with adequate information to review the study,
- Provides the IRB with documents for ongoing review,
- Secures written IRB approval before initiating the study or instituting any changes to the protocol as approved,
- Provides written summaries of the trial status to the IRB annually, or as requested,
- Provides the IRB with all documents subject to their review.
- Manages the medical care of subjects:
- Ensures that a qualified physician is responsible for all trial-related medical decisions,
- Assesses subject compliance with the test article and follow-up visits,
- Assesses subject’s response to therapy,
- Evaluates for adverse experiences,
- Ensures that medical care is provided to a subject for any adverse event(s).
- Protects the rights and welfare of subjects:
- Reports all serious adverse events immediately to the sponsor and IRB,
- Obtains a signed and dated Informed Consent from the subject or subject’s legal representative before initiating any study-related procedures,
- Informs the subject or subject’s legal representative about all aspects of the clinical trial.
- Ensures validity of the data reported to sponsors:
- Ensures the accuracy, completeness, legibility, and timeliness of case report forms,
- Ensures that case report forms accurately reflect source documents,
- Explains any discrepancies between source documents and case report forms,
- Endorses changes or corrections to a case report form.
- Ensures documentation of study-related procedures, processes, and events:
- Documents deviations from the approved protocol,
- Documents and explains premature un-blinding of the investigational product(s),
- Documents that Informed Consent has been obtained from the subject or subject’s legal representative,
- Ascertains the reason for a patient’s premature study withdrawal,
- Documents adverse experiences,
- Complies with written procedures to document changes to data and/or case report forms,
- Maintains trial documents as required by regulations and sponsor for the appropriate timeframe and under secure conditions,
- Provides study reports as requested by the sponsor, IRB, and regulatory authorities.
- Ensures the proper use and storage of investigational agents:
- Develops thorough familiarity with the use of the investigational product(s),
- Reads the current investigator’s brochure, product insert, or other source information,
- Assumes responsibility for the investigational product at the trial site,
- Ensures the proper use and storage of the investigational product(s) at the trial site,
- Assigns responsibility to the appropriate research pharmacy personnel,
- Reviews the proper use of the study article(s) by the subject(s).
- Supports site operations:
- Communicates effectively with subjects, research team, IRB and sponsor,
- Meets regularly with the research team to discuss subject participation and protocol progress,
- Ensures that all research staff are informed about the protocol and investigational agents,
- Is knowledgeable about regulatory requirements and GCP standards,
- Prepares for and attends investigator and start-up meetings,
- Participates in monitoring visits and audits as appropriate,
- Permits monitoring and auditing by the sponsor and appropriate regulatory authorities,
- Delegates authority at the site appropriately,
- Ensures that all research staff is informed about their trial-related duties and functions.
- Maintains professional and technical knowledge:
- Attends educational workshops,
- Reviews professional publications,
- Participates in professional societies.
- Investigator performs additional duties:
- Reviews all protocols promptly and comments on safety and feasibility.
- Communicates with potential sponsors at pre-study site visits.
- Reports to operations management regarding protocol-specific training needs before protocol initiation and protocol compliance during the conduct of the study.
- Ensures staff understanding of medical aspects of study clinical conduct and acceptance of roles and responsibilities.
- Creates and maintains open and supportive communications with the research team, sponsor representative, and other auditors.
- Works in a collaborative, effective manner with the research team as well as sponsor representatives to meet research objectives
- Communicates effectively with other partners in clinical research including Sub-Investigators, study volunteers, IRB staff, and the sponsor.
- Recruits and trains Sub-Investigators.
- Cooperates with site audits and FDA inspections.
- Supervises (hires, trains, counsels, and evaluates) full-time, part-time, and PRN physicians and/or Investigators.
- Works with Operations management to plan and project needs for his/her department.
- Reviews any medical-related work instructions to include medical standing orders.
- Reviews and signs all SOPs for WCT.
- Works with Operations management to resolve any concerns or requests for study conduct issues.
- Vice President/Medical Director performs additional duties:
- Bi-weekly meets with Executive Vice President/General Manager of WCT Early Phase Services & Bioanalytical Sciences, Director of Operations and Associate Director of Clinical Conduct to discuss overall operations of the Phase I clinic, quality enhancements/improvements required, procedure and process changes, and all other business requirements deemed
- Actively participates in all Corporate Executive Management meetings and functions.
- Works closely in the medical community of San Antonio to develop alliances and strategic relationships with medical facilities, physician groups, and individual physi
- Works closely with Corporate Recruiting to develop needed patient population
- Accompany Business Development to strategic client presentations to promote WCT Early Phase
- Reviews all protocols promptly and comments on safety and feasi
- Communicates with potential sponsors at pre-study site
- Reports to operations management regarding protocol-specific training needs before protocol initiation and protocol compliance during the conduct of the
- Ensures staff understanding of medical aspects of study clinical conduct and acceptance of roles and
- Creates and maintains open and supportive communications with the research team, sponsor representative, and other
- Works in a collaborative, effective manner with the research team as well as sponsor representatives to meet research objecti
- Communicates effectively with other partners in clinical research including Sub-Investigators, study volunteers, IRB staff, and the
- Recruits and trains Sub-
- Cooperates with site audits and FDA inspecti
- Supervise (hires, trains, counsels, and evaluates) full-time, part-time, and PRN physicians and/or investigators.
- Works with Operations management to plan and project needs for his/her
- Reviews any medical-related DOPs to include medical standing
- Reviews and signs all SOPs for
- Works with Operations management to resolve any concerns or requests for study conduct i
OTHER SKILLS AND ABILITIES:
- At least 2 years’ experience in performing physicals, assessing, and treating patients.
- Strong supervision, interpersonal and communication skills.
- Must possess exceptional organizational and planning skills and good documentation skills.
- Must have good conflict resolution skills and be committed to quality.
- Must be punctual and have a flexible work schedule.
- At least 2 years’ experience in clinical research as an investigator or sub-Investigator.
- In-depth knowledge of the clinical research process, including Good Clinical Practices.
- Able to make good, sound decisions under stress and with time restraints.
- Possible equipment includes, but is not limited to microscope, computers, rolling carts, fax machines, photocopiers, telephone, lab apparatus, mop/broom, needles, spirometry, centrifuges, and allergy testing equipment, scales, calculators, vital signs equipment, ECG equipment, defibrillator, suction device, pipettes, and other medical equipment.
Required: Medical (M.D.) degree or Doctor of Osteopathy (D.O.) with at least 5 years of clinical research experience.
Preferred: Medical degree plus at least 5 years of clinical research experience with 2 years in Phase 1 research.
Employment Type: Contractor
Community / Marketing Title: Contractor Medical Director
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: San Antonio, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.