Clinical Research Associate

Duties will include supporting the manager with maintaining research methods, tracking patients in the study, providing feedback and suggestions on the development / revision of research protocols and regulatory correspondence, and maintaining accurate and updated manuals of procedures for the studies.

This position will serve as lead coordinator on one or more BTN studies. The Coordinator will also help oversee the network of partnering sites and contribute to the identification, selection, and negotiation of additional sites and studies, ensuring that partnering sites have the skill level and availability necessary to properly conduct the research.

This position will also ensure that BTN staff are adhering to the appropriate SOPs and achieving excellence in patient / participant care.

Due to the nature of the research (sexual assault) and the geographical spread of study sites across time zones, typical encounters are after business hours and on the weekends, therefore it is typical that the position will provide support, respond when a potential research subject has been identified and make decisions.

Knowledge Professional - Professional knowledge and skill in social / clinical research principles, methods and processes (technical and / or theoretical) used to conduct a systematic and objective inquiry including study design, methods of data / information collection and analysis, and interpreting and reporting results.

Knowledge of statistics and related information technology and database storage and management. Ability to keep current with developments and trends in area(s) of expertise.

Project Design - Ability to plan and coordinate methods and techniques to meet social / clinical research objectives, including project resources, methods of data / information collection, and quality control.

Project / Program Administration - Ability to manage (i.e., direct the affairs or interests of) and administer social / clinical research project(s) / program(s) tasks, activities, protocols, and timelines.

Ability to manage resources and monitor activities associated with the progression of the project(s) / program(s).

Data / Information Analysis / Management - Ability to monitor, collect, and maintain research data / information to assess its accuracy, validity, and integrity.

Ability to interpret and evaluate results. Ability to prepare reports and / or presentations. Ability to conduct trend and impact analysis.

Ability to project probable outcomes. Ability to create and maintain databases and apply criteria for interaction of data.

Communication - Ability to convey clear and concise information verbally and in written form. Ability to effectively present ideas to individuals or groups to ensure that they understand the information and message.

Ability to present research results and summaries and adhere to reporting requirements of research project(s) / program(s).

Ability to contribute to the writing of publications, reports, and products.

Instruction - Ability to instruct and train staff, students, faculty and / or other clients in the performance of procedures and operation of equipment.

Principal Responsibilities

Supervision / Management :

Better Tomorrow Network Team Development and Training

Proactively identify areas for study team improvement related to study execution (e.g., recruitment, retention, study visit flow, etc.

develop and implement solutions.

Provide training in and oversee all areas of clinical research as necessary.

Assist with the planning and development of training for junior personnel.

Assist with the onboarding of new personnel.

Provides full supervision to research assistants and student interns, including management of the performance review process and disciplinary issues as needed.

Set work schedules and approve leave requests.

Research - Project Management

Study Coordination

The coordinator of a study will be the individual responsible for tracking participants through the study, and for knowing what procedures need to be done and when they need to be done.

Depending on the study, certain tasks of the study may be performed by RAs, but the buck always stops with the coordinator.

That is, the coordinator is ultimately responsible for the completion of all study-related tasks and the excellent overall conduct of the study.

The coordinator owns the study. The tasks of this work are too numerous and varied to list, but examples of tasks that fall under this work include :

Lead the coordination of study start-up activities and project planning, including development of materials such as study protocols and grant proposals.

Independently develop standard operating procedures to promote quality assurance and standardized best practices, as applicable.

Assist in overseeing site initiation, study start-up meetings, and closeout for research studies. Lead meetings as applicable.

Assess the needs of various research studies and employ strategies to optimize recruitment and retention rates. Oversee the recruitment and screening of research participants.

Assess the needs of a project, employ strategies, and make changes to optimize study visit flow.

Create complex source documentation, checklists, and / or other resources to aid with compliant data collection.

Develop complex data management tools / systems.

Track and report study expenditures. Contribute to the development of study budgets and assist with invoicing funders as applicable.

Make recommendations in the area of the research project as necessary.

Maintain up to date administrative and regulatory documents (e.g., IRB, CoC).

Ensure study records and extraction forms are completed in a timely manner.

Develop and maintain updated and accurate Manuals Of Procedures for studies. (This MOP is the master directions for the study, so that anyone could pick up this manual and understand how to conduct the study from beginning to end.

MOPs are sometimes provided by companies for industry-sponsored studies.)

Research Administration

Network Coordination

Perform the following, as requested :

Oversee current network of partnering sites.

Lead site engagement.

Lead the identification, selection, and negotiation of additional studies and sites.

Design methods of successfully operationalizing studies.

Develop and maintain methods for identifying eligible patients, consenting patients, and performing follow-up assessments.

Research Compliance

Regulatory and Compliance

Perform reviews of regulatory submissions and materials from study staff; provide correction and feedback as necessary.

Ensure study staff follow best practices for regulatory documentation.

Create and maintain administrative study documentation (e.g., delegation of authority logs, training records).

Develop and submit complex regulatory applications and / or study materials (e.g., recruitment materials, informed consent forms).

Identify, gather, and store required regulatory documentation.

Prepare for study monitoring, coordinate and participate in monitoring visits, resolve queries and decide corrective action to be taken, as applicable.

Convey major points of monitoring reports to the Principal Investigator and supervisory personnel. Track, document, and report protocol deviations and adverse events.

Lead the conduct of root cause analyses (RCAs) and development of corrective action plans (CAPAs).