Medical Director - Investigator - San Antonio, TX - Office-Based
Location: San Antonio, TX, USA
Requisition Number: 6666
Position Title: Medical Director - Investigator
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials (WCT), and we are a global team of almost 3,000 experts, bright thinkers, idealists, and doers, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What the Principal Investigator/Medical Director, Early Phase Does at Worldwide
Ensures adherence to protocol requirements, protects the rights and welfare of subjects, and assures the integrity of data generated at the site. The role directs the conduct of the clinical investigation according to federal and state regulations including guidance documents. Directly supervises all full-time, part-time, and PRN Investigators and Sub-Investigators. Indirectly supervises and oversees all clinical staff.
What you will do
Ensure protocol compliance:
o Possess a thorough understanding of the requirements of each protocol,
o Determine whether inclusion/exclusion criteria apply to the study population,
o Ensure recruitment goals are reasonable and attainable,
o Assess overall protocol feasibility,
o Follow the trial’s randomization procedures,
o Maintain protocol compliance and do 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),
o Review the inclusion/exclusion criteria, schedules visits, endpoint criteria, and investigational article use with the research team.
Support review by a duly constituted IRB:
o Provide the IRB with adequate information to review the study,
o Provide the IRB with documents for ongoing review
o Secure written IRB approval before initiating the study or instituting any changes to the protocol as approved,
o Provide written summaries of the trial status to the IRB annually, or as requested,
Manage the medical care of subjects:
o Ensure that a qualified physician is responsible for all trial-related medical decisions
o Assess subject compliance with the test article and follow-up visits,
o Assess the subject’s response to therapy and evaluates for adverse experiences,
o Ensure that medical care is provided to a subject for any adverse event(s).
Protect the rights and welfare of subjects:
o Report all serious adverse events immediately to the sponsor and IRB,
o Obtain a signed and dated Informed Consent from the subject or the subject’s legal representative before initiating any study-related procedures,
o Inform the subject or the subject’s legal representative about all aspects of the clinical trial.
Ensure the validity of the data reported to sponsors:
o Ensure the accuracy, completeness, legibility, and timeliness of case report forms,
o Ensure that case report forms accurately reflect source documents, and explain any discrepancies
o Endorse changes or corrections to a case report form.
• Ensure documentation of study-related procedures, processes, and events:
o Document deviations from the approved protocol,
o Document and explains premature un-blinding of the investigational product(s),
o Document that Informed Consent has been obtained from the subject or the subject’s legal representative,
o Ascertain the reason for a patient’s premature study withdrawal,
o Document adverse experiences,
o Comply with written procedures to document changes to data and/or case report forms,
o Maintain trial documents as required by regulations and sponsor for the appropriate timeframe and under secure conditions,
o Provide study reports as requested by the sponsor, IRB, and regulatory authorities.
Ensure the proper use and storage of investigational agents:
o Develop thorough familiarity with the use of the investigational product(s),
o Read the current investigator’s brochure, product insert, or other source information,
o Assume responsibility for the investigational product at the trial site,
o Ensure the proper use and storage of the investigational product(s) at the trial site,
o Assign responsibility to the appropriate research pharmacy personnel,
o Review the proper use of the study article(s) by the subject(s).
Support site operations:
o Communicate effectively with subjects, research team, IRB, and sponsor,
o Meet regularly with the research team to discuss subject participation and protocol progress,
o Ensure that all research staff are informed about the protocol and investigational agents,
o Is knowledgeable about regulatory requirements and GCP standards,
o Prepare for and attends investigator and start-up meetings,
o Participate in monitoring visits and audits as appropriate,
o Permit monitoring and auditing by the sponsor and appropriate regulatory authorities,
o Delegate authority at the site appropriately,
o Ensure that all research staff is informed about their trial-related duties and functions.
Additional duties include:
o Review all protocols promptly and evaluates comments on safety and feasibility.
o Communicate with potential sponsors at pre-study site visits.
o Report to operations management regarding protocol-specific training needs prior to protocol initiation and protocol compliance during the conduct of the study.
o Ensure staff understanding of medical aspects of study clinical conduct and acceptance of roles and responsibilities.
o Create and maintains open and supportive communications with the research team, sponsor representative, and other auditors.
o Communicate effectively with other partners in clinical research including Sub-Investigators, study volunteers, IRB staff, and the sponsor.
o Recruit and trains Sub-Investigators.
o Cooperate with site audits and FDA inspections.
o Supervise (hires, trains, counsels, and evaluates) full-time, part-time, and PRN physicians and/or Investigators.
o Work with Operations management to plan and project needs for his/her department.
o Review any medical-related work instructions to include medical standing orders.
o Review and sign all SOPs for WCT.
o Work with Operations management to resolve any concerns or requests for study conduct issues.
o Actively participates in all Corporate Executive Management meetings and functions to discuss overall operations of the Phase I clinic, quality enhancements/improvements required, procedure and process changes, and all other business requirements deemed necessary.
o Work closely in the medical community of San Antonio to develop alliances and strategic relationships with medical facilities, physician groups, and individual physicians.
o Work closely with the Participant Recruiting Team to develop patient population database.
o Accompany Business Development to client presentations to promote Worldwide Early Phase Services.
What you will bring to the role
- 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 a microscope, computers, rolling carts, fax machines, photocopiers, telephone, lab apparatus, mop/broom, needles, spirometry, centrifuges, allergy testing equipment, scales, calculators, vital signs equipment, ECG equipment, defibrillator, suction device, pipettes, and other medical equipment.
- Required: Medical (M.D.) degree with at least 2 years of clinical research experience.
- Preferred: Medical degree plus at least 5 years of clinical research experience with 2 years in Phase 1 research.
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Medical Director - Investigator - San Antonio, TX - Office-Based
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 is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.