SUMMARY: Ensures adherence to protocol requirements, protects the rights, safety 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 Associate Medical Director-Investigator works under the direct supervision and guidance of the Medical Director. The Associate Medical Director – Investigator indirectly supervises and oversees all clinical staff.
Tasks may include but are not limited to:
- Ensures protocol compliance:
- Possesses a thorough knowledge and understanding of the requirements of each protocol.
- Determines whether inclusion/exclusion criteria are applicable 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 deviation 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, procedures, scheduled visits, end point criteria and investigational article use with the research team.
- Supports review by a duly constituted IRB:
- Provides the IRB with documents for ongoing review and adequate information to review the study.
- Secures written IRB approval prior to 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 and determines severity and relationship to the investigational product.
- 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 prior to initiating any study-related procedures.
- Informs the subject or legal representative about all aspects of the clinical trial.
- Always considers subject safety and welfare the first priority.
- 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.
- Reviews and signs data management queries and case report forms in a timely manner.
- 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 legal representative.
- Ascertains the reason for a subject’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 authority(ies).
- Ensures the proper use and storage of investigational agents:
- Develops thorough knowledge and 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 and are appropriately trained in any protocol specific procedures.
- 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 are informed about their trial-related duties and functions.
- Maintains professional and technical knowledge:
- Attends educational workshops and engages in other activities to maintain continuing medical education requirements.
- Reviews professional publications.
- Participates in professional societies.
- Participates in Protocol Feasibility Assessments
- Reviews protocol synopses and draft protocols prior to finalization to determine feasibility, appropriateness of safety and other assessments, and amount and level of staffing required for study execution.
- Undertakes research necessary to provide valuable input on protocol design based upon the investigational product and known toxicology information.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
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 and honesty.
- 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 time constraints.
- 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, ophthalmoscope/otoscope and other medical equipment.
Required: Medical (M.D.) degree or Doctor of Osteopathy (D.O.)
Preferred: Medical degree plus at least 2 years of clinical research experience
Other: Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, written communication, client contact, and attention to detail, multiple tasks, frequent interruptions, fluctuation in work load.
Possible physical demands include, but are not limited to: lifting and carrying of objects weighing 5-50 lbs., hearing, seeing, gross and fine motor use of upper extremities, kneeling, walking, standing, leaning over for extended periods of time, squatting, eye strain/fatigue, climbing, pushing, pulling, reaching, and exposure risk to potentially infectious blood and/or body fluids, and/or hazardous fumes or chemicals.
Must be able to make sound medical judgments on the health and safety of subjects during their participation in a clinical research study. Must be able to follow written and verbal communication. Must be punctual. The Associate Medical Director – Investigator will have a large amount of contact with staff, study participants, and Sponsors. Professionalism will be of the utmost importance as a representative of WCT.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
For more information, contact
Tina Roberts, President
JONATHAN CHASE EXECUTIVE SEARCH
588 Sutter Street, Suite 349
San Francisco, CA 94102