Roles and Responsibilities

A third consideration is identifying and differentiating the roles and responsibilities of each staff member by breaking down each study-related task and identifying the associated activities for implementing the intervention study. As there is a high level of interdependency in the roles of staff members on an intervention study, clearly articulating how each staff member communicates and relates to another is also important.

Table 22.1 presents 10 common staff positions and their associated key roles and skill sets. Although this list is not exhaustive and is most relevant to a Phase III efficacy trial, it provides guidance to the potential staffing needs for other types and phases of intervention development work.

One key role in intervention research is that of the project coordinator/ manager or director. In early intervention development phases, the primary investigator may serve in this capacity. However, even for pilot efforts, or in testing and implementation phases, it is typically necessary to hire a part- to full-time coordinator or project manager. The role of this person will vary on the basis of the scope and

TABLE 22.1 Ten Key Roles on a Study Designed to Test a Behavioral Intervention

Role

Key Responsibilities

Key Skill Set Needed

Principal

investigator

  • ? Oversees scientific integrity of study
  • ? Contributes content expertise
  • ? Establishes project structure
  • ? Content expertise
  • ? Skill developing and running project staff
  • ? Ability to oversee budget

Coinvestigator(s)

? Contributes discrete area of content expertise

? Content expertise

Project

coordinator/

manager

  • ? Day-to-day coordination
  • ? Trains and supervises staff
  • ? Meets with investigative team
  • ? Organizes reports
  • ? Generates study updates (tables, charts, narrative summaries)
  • ? Coordinates recruitment efforts
  • ? Detail oriented
  • ? Problem solver
  • ? Good writing skills
  • ? Good communicator
  • ? Organized
  • ? Knowledgeable about Institutional Review Board (IRB)
  • ? Knowledgeable about data entry

Recruitment

coordinator

  • ? Establishes recruitment strategy
  • ? Outreach and tracking
  • ? Assists with enrollment
  • ? Provides recruitment and enrollment accrual reports/ charts
  • ? Detail oriented
  • ? Good communicator
  • ? Organized
  • ? Able to provide brief talks to stakeholders/ recruitment sites

TABLE 22.1 Ten Key Roles on a Study Designed to Test a Behavioral Intervention (Continued)

Role

Key Responsibilities

Key Skill Set Needed

Interviewer(s)

  • ? Obtains informed consent
  • ? Interviews in-person, telephone, or online
  • ? Checks code work for accuracy
  • ? Reports adverse events
  • ? Good problem-solving skills
  • ? Able to follow a protocol
  • ? Able to build rapport with study participants
  • ? Organized
  • ? Attention to detail
  • ? Able to keep project coordinator informed in a timely way
  • ? Comfortable with being observed or monitored and obtaining feedback for fidelity purposes
  • ? Some knowledge of working with targeted study population

Interventionist(s)

  • ? Implements experimental and/or control group protocols
  • ? Completes study documentation
  • ? Reports adverse events
  • ? Balances protocol with clinical prerogatives
  • ? Able to follow a protocol
  • ? Able to build rapport with study participants
  • ? Organized
  • ? Comfortable with being observed or monitored and obtaining feedback for fidelity purposes
  • ? Some knowledge of working with targeted study population

Data entry/

coders/

cleaners

  • ? Cleans data
  • ? Enters data
  • ? Checks for accuracy of data entry
  • ? Attentive to detail
  • ? Knowledge of software program used
  • ? Organized

Statistician

? Assists in determining statistical analyses and interpretation

? Working knowledge of clinical trial methodology, intention to treat, case modeling, moderator and mediation analyses

Database

manager

? Establishes and maintains data files

? Working knowledge of statistical programs, setting up data collected over time at multiple testing occasions (if relevant)

Research assistant

? Helps with daily research-related activities such as duplicating materials, entering data

  • ? Ability to work independently
  • ? Organized
  • ? Detail oriented

nature of the study. Roles may include but are not limited to coordination of and involvement in day-to-day operations; recruitment strategies; assigning interviewer and intervention schedules; data entry procedures; fidelity activities; training and supervising interviewers; and institutional review board submissions and required yearly reports to funders.

Persons with previous research experience and who are prepared at a master’s or, preferably, a doctoral level who can excel at this position may be preferred. Having some research experience can be helpful as there are many moving pieces in an intervention study and field conditions often change and need to be efficiently managed. Nevertheless, individuals with a bachelor’s degree with previous research experience and who are savvy, detail oriented, and organized may also perform effectively in this position.

Another key position is the interviewer/assessor. The needed level of expertise for this role will depend upon the nature and scope of the data being collected. If clinical testing is necessary, then persons with specific clinical training may be required. For vulnerable populations such as persons with cognitive impairments, or those with significant hearing loss, an understanding of some of the associated challenges is needed. Bilingualism and bicultural understandings may be critical as well depending upon, of course, the targeted populations. For most studies, however, individuals who are bachelor or master’s prepared in any of the social sciences (sociology, anthropology, psychology) or who have a social work or public health background can serve as excellent interviewers. In all cases, personnel need to have training to orient them to the cultural nuances, needs, and preferences of the target population in addition to, of course, the study protocols and interview battery.

The skill set needed by interventionists is obviously dependent upon the content of the intervention and control groups. Careful thought should be given to who can deliver the intervention or an active control group condition (See Chapter 8 on attention control condition). The decision as to the skill set needed for an interventionist has important implications for the potential of implementation and scalability of that intervention if it is proven to be effective. For example, use of highly skilled and paid clinicians or health professionals as interventionists may be appropriate for the testing phase of an intervention. However, their involvement may in turn limit the future implementation potential of the intervention if real-world settings do not have access to the same level of trained personnel. At the efficacy trial phase, traditionally, interventionists are carefully selected such that only the most skilled individuals are selected to serve in this role. As the emphasis at this phase is on maximizing internal validity so that positive results may be attributable to the intervention, the goal is to minimize threats of possible confounding external factors such as an interventionist’s poor skill level, style, or personality. Nevertheless, this overemphasis on specially selected interventionists may be limiting and not reflect the real-world circumstances in which the intervention ultimately will be embedded. Thus, achieving a balanced approach (e.g., adequately trained interventionists but possibly not trained specialists unless necessary) can be an important goal early on in the development of an intervention. This point is discussed more fully in Chapter 20.

Unique to behavioral intervention research is the high level of interdependency in roles and responsibilities among staff members. For example, in an efficacy trial, one person may be responsible for screening and enrolling study participants, another person may be responsible for randomization, another may be responsible for assigning interviews, and yet another for conducting the interviews. As each staff member is dependent upon the other sharing key information that may be needed by others, establishing a communication and work flow among team members (e.g., who does what and when) is essential.

A related point is that a backup plan is important to put into place in which the key roles and responsibilities of each staff member can be carried out by another. Study milestones must be met regardless of staff turnover, personal crisis, or other issues. Thus, cross-training of staff to potentially fill each other’s roles is critical and must be factored in when designing the study and identifying staffing requirements. A project, at whatever stage of the pipeline, should not be dependent upon one staff member. If possible, hiring more than one interviewer and interventionist is critical to account for days off for vacation, sick days, and leaves of absence or for dismissals or individuals who choos to leave the position.

 
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