Atlanta Center for Medical Research

Scope

JOB TITLE – Sub-Investigator

GENERAL SUMMARY OF DUTIES – Promotes good clinical practices in the conduct of clinical investigations. The Investigator assumes responsibility other than those responsibilities specifically intended for the PI. Ensures adherence to protocol requirements, protects the rights and welfare of participants, 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.

SUPERVISOR – VP of Operations

SUPERVISES – N/A

Duties

DUTIES INCLUDE, BUT ARE NOT LIMITED TO:

1.PROVIDES INVESTIGATOR QUALIFICATIONS AND AGREEMENTS By:

  • Maintaining a current, up-to-date curriculum vitae
  • Maintaining current licensure to practice
  • Providing the sponsor and IRB with documentation of credentials as requested
  • Demonstrating the proper education, training and experience to conduct the clinical investigation
  • Assuming responsibility for the conduct of the clinical investigation
  • Signing the Form FDA 1572 as appropriate
  • Signing the protocol as required
  • Signing sponsor contract(s) as appropriate
  • Documenting the financial aspects of the trial

2.ENSURES PROTOCOL COMPLIANCE By:

  • Possessing a thorough understanding of the requirements of each protocol
  • Determining that inclusion/exclusion criteria are applicable to the study population
  • Ensuring recruitment goals are reasonable and attainable
  • Assessing overall protocol feasibility
  • Following the trial’s randomization procedures
  • Not implementing 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 participant)
  • Reviewing the inclusion/exclusion criteria, schedule of visits, end point criteria and investigational article use with the research team
  • Document adequate medical history for each study participant

3.ENSURES INITIAL AND ONGOING REVIEW BY A DULY CONSTITUTED IRB By:

  • Providing the IRB with adequate information to initially review the study (i.e./ protocol, investigator’s brochure, informed consent form, recruitment advertisements and any written information to be given to participant(s)
  • Providing the IRB with documents for ongoing review (i.e. amendments to the protocol, adverse events, deviations or new information)
  • Securing written IRB approval prior to initiating the study or instituting any changes to the protocol as approved
  • Providing written summaries of the trial status to the IRB annually, or as requested
  • Providing the IRB with all document’s participant to their review

4.ASSUMES ADEQUATE RESOURCES ARE AVAILABLE TO CONDUCT THE STUDY By:

  • Having adequate number of qualified staff to conduct the study
  • Having adequate facilities to conduct the study
  • Ensuring he/she has adequate time to conduct and supervise the stud

5.MANAGES THE MEDICAL CARE OF PARTICIPANTS By:

  • Ensuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related medical decisions
  • Assessing participant compliance with the test article and follow-up visits
  • Assessing participant’s response to therapy
  • Evaluating for adverse experiences
  • Ensuring that medical care is provided to a participant for any adverse event(s)
  • Informing a participant when medical care is needed to treat an intercurrent illness(es)
  • Informing the participant’s primary physician about their participation in the trial

6.PROTECTS THE RIGHTS AND WELFARE OF PARTICIPANTS By:

  • Reporting all serious adverse events immediately to the sponsor and IRB
  • Obtaining a signed and dated informed consent from the participant or participant’s legal representative prior to initiating any study-related procedures
  • Informing the participant or legal representative about all aspects of the clinical trial
  • Providing new information about the study or test article(s).

7.ENSURES VALIDITY OF THE DATA REPORTED TO THE SPONSOR By:

  • Ensuring the accuracy, completeness, legibility and timeliness of case report forms
  • Ensuring that case report forms accurately reflect source documents
  • Explaining any discrepancies between source documents and case report forms
  • Endorsing changes or corrections to a case report form

8.ENSURES DOCUMENTATION OF STUDY-RELATED PROCEDURES, PROCESSES AND EVENTS By:

  • Documenting deviations from the approved protocol
  • Documenting and explaining premature unblinding of the investigational product(s)
  • Documenting that informed consent has been obtained from the participant or legal representative
  • Ascertaining the reason for a patient’s premature study withdrawal
  • Documenting adverse experiences
  • Complying with written procedures to document changes to data and/or case report forms
  • Maintaining trial documents as required by the regulations and sponsor for the appropriate time-frame and under secure conditions
  • Providing study reports as requested by the sponsor, IRB and regulatory authority(ies)

9.ENSURES THE PROPER USE AND STORAGE OF INVESTIGATIONAL AGENTS By:

  • Being thoroughly familiar with the use of the investigational product(s)
  • Reading the current investigator’s brochure, product insert, or other source information
  • Assuming responsibility for the investigational product at the trial site
  • Ensuring the proper use and storage of the investigational product(s) at the trial site
  • Assigning responsibility to the appropriate research pharmacy personnel
  • Reviewing the proper use of the study article(s) by the participant(s)

10.DIRECTS SITE OPERATIONS By:

  • Communicating effectively with participants, research team, IRB and sponsor
  • Meeting regularly with the research team to discuss participant participation and protocol progress
  • Ensuring that all research staff are informed about the protocol amendments and investigational agents
  • Being knowledgeable about regulatory requirements and GCP standards
  • Preparing for and attending investigator and start-up meetings
  • Participating in monitoring visits and audits as appropriate
  • Permitting monitoring and auditing by the sponsor and appropriate regulatory authorities
  • Making available to monitors, auditors, IRB and regulatory authority(ies) all requested trial-related records
  • Delegating authority at the site appropriately
  • Ensuring that all research staff are informed about their trial-related duties and functions
  • Maintaining a list of qualified persons and their corresponding trial-related delegated duties.
  • Other duties as assigned.

Qualifications

KNOWLEDGE, SKILLS & ABILITIES – This position requires the following minimal requirements:

  • Skill in organization and record maintenance;
  • Skill in developing and maintaining effective working relationships with supervisors, peers and co-workers.
  • Ability to provide flexibility in work and schedule when needed;
  • Ability to complete paperwork with precision and attention to detail;
  • Ability to complete tasks and assignments within the required timeframe;
  • Ability to react calmly and effectively in emergency situations;
  • Ability to interpret, adapt and apply guidelines and procedures;
  • Ability to work independently as well as functioning as part of a team;
  • Ability to communicate clearly both written and verbally

EDUCATION – Appropriate education and training (doctoral level education, appropriate internship, residency, fellowships)

EXPERIENCE

  • Experience and training in the conduct of clinical research.
  • Understanding of regulatory requirements, principles of GCP, and biomedical research ethics

CERTIFICATE/LICENSE– M.D. / D.O.

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00 a.m. to 4:30 p.m. May be required to complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

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