Marketing Coordinator

Introduction: The primary purpose of the Behavioral Health Research Coordinator (RC) to coordinate clinical research studies including recruitment, screening, consenting and enrollment of subjects, collect data on Case Report Forms (CRF), schedule study visits, administer study assessments and provide administrative support to the Principal Investigator (PI).  The RC will have previous experience with behavioral or mental health or psychology clinical trials or research studies.  The RC will interact with participants throughout the course of the study, and must be comfortable working closely with participants and administering behavioral and psychological measures.

Major Duties: 

Program management       

  • Serves as project coordinator in support of one or more principal investigators who are leading one or more research studies and/or clinical demonstration projects. The incumbent will be expected to meet with project investigators on a regular basis. Working closely with the principal investigator, the incumbent will manage routine day-to-day research activities. The incumbent will create and oversee project management tracking systems to assure the study remains on schedule and in compliance related to data collection goals, budget expenditures, and research regulation compliance.
  • Directs clinical research activities and assists investigators with all aspects of clinical trials and the management of patient data;
  • Triage communication between the site, the Study Chairs’ Office, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), and the Cooperative Studies Program Coordinating Center (CSPCC), sponsors and the Institutional Review Board (IRB); Prepares regulatory reports to the IRB and subsequent committees and submits for their review
  • Ensures good clinical practices to achieve optimal research outcomes and ensure the study conduct and essential documents meet VHA Directive1200.05, US FDA (U.S. Food and Drug Administration) and sponsor requirements; Responsible for regulatory requirements related to clinical trials, human subjects’ protections, and data integrity sufficient to ensure study compliance.
  • Plans the work to be accomplished and setting and adjusting priorities for the program
  • Records and maintains results and records of all tests or assessments as per protocol and in a manner complying with research regulations, prepares project administrative and statistical reports, and organizes and maintains the resulting database(s).
  • Trains and orients new study team members
  • Oversees all administrative duties related to the study program.  This is a critical function because it combines patient contact, which requires good clinical skills, and administration.
  • Make appropriate clinical judgments to refer the patient to the appropriate member of the study team.

Clinical Trial Conduct and Recruitment                

  • Recruits and screens subjects for moderate to complex clinical studies to ensure that they meet the study’s eligibility requirements which includes consulting the referring clinician to establish a provisional PTSD diagnosis and other inclusion and exclusion criteria.  Uses objective rating techniques to identify potential candidates for participation.
  • Ensures patients receive the necessary information regarding research procedures and treatments (under the direction of the PI);
  • Develops relationships with clinicians and other mental health providers to that facilitate subject recruitment;
  • Acknowledges and responds to patient needs as they occur to ensure patient safety and human protection compliance;
  • ·Conducts the informed consent procedures and ensures that all aspects of the process are met; reviews the Informed Consent form with a potential participant to explain the study in detail so that participants will be fully informed of the nature and extent of research study participation, the objectives of the study, and the treatments to which they will be randomly assigned, determine if a suicide risk assessment is needed by a mental health clinician
  • Collects clinical and other data required for each research study according to the schedule in the protocol. This includes obtaining the data and completing the CRFs with detailed clinical and medication histories, assessments and procedures using the required electronic data capture and clinical trial data management system
  • Reviews laboratory data and medication administration for potential adverse effects.
  • Verifies that all required data items have been answered for those CRFs that are completed by the subjects;
  • Correct data discrepancies/inconsistencies as identified by the sponsor;
  • Contact the subjects by phone or letter to remind them of upcoming study visits and to encourage compliance with the protocol;
  • Provide the subjects with a follow-up schedule of visits throughout the entire study;
  • Ensure that records for each subject’s study participation are complete and up-to-date, including the subject’s study file, informed consent forms (ICFs), CRFs, notes, and additions (e.g., progress notes) to the subject’s medical center records.
  • Applies knowledge of depression and other psychiatric diagnoses, psychiatric medications and their medical risks for evaluating participants, collecting data, and assessing adverse events and follow up.
  • Identifies adverse events and side effects symptoms, especially psychiatric/ mental health issues and medications which might require crisis intervention or referrals in order to facilitate treatment of clinical research participants, either in person or over the phone.

Manages and Administers Research and Clinical Tests/Assessments                       

  • Manages implementation, control and reporting on clinical tests and assessments.  Conducts state of the art diagnostic assessments, neurocognitive batteries and psychopathology rating scales, such as the Clinician Administered PTSD Scale (CAPS).  Assessments may be of qualitative and/or quantitative nature.
  • Provides training on the tests and assessments for other team members.
  • Performs other related duties for research and clinical tests and assessments as assigned.
  • Administers demographic questions, the screening assessments and indices, such as sleep quality scales, PTSD assessment questionnaires, Quality of Life questionnaires
  • Administers standard tests to measure and track indicators.  Obtains necessary supplemental information from databases to measure and track indicators, severity of illness, and response to treatment.
  • Administers or monitors administration of tests and measurements required by project design.

ADMINISTRATIVE DUTIES

  • Records data from samples to ensure that all tracking data is organized and is monitored during the progress of the study.
  • Identifies test/ assessment results and trends requiring further analysis.
  • Maintains records, prepares project administrative and statistical reports.and organizes and maintains the resulting database(s).
  • Create and maintain a filing system for the study and program records that includes a file of all case report forms for each patient and is compliant with regulations.
  • Ability to work with Microsoft office (word, excel, windows) and electronic data collection software.
  • Performs activities required to support the administrative and scientific activities of the study that may include the following: handle the telephone, type correspondence and manuscripts; file and record-keeping and other general administrative duties

Performs other duties as assigned.