Research Associate, Biomedical

FENWAY HEALTHBoston, MA

About The Position

Under the supervision of the Project Director- Biomedical Clinical Trials, the Research Assistant works with other research staff in implementing prevention and treatment trials according to specified study protocols.

Requirements

  • Attention to detail.
  • Some understanding of subjective physical assessment and interviewing.
  • Ability to function autonomously in a collaborative interdisciplinary team.
  • Excellent communication and interpersonal skills is a must.
  • Ability to work in a fast paced environment.
  • Capacity for detail oriented multitasking.
  • Ability to work harmoniously with diverse groups of individuals required.
  • Demonstrated ability to work respectfully and effectively with individuals from a wide range of backgrounds, perspectives, and life experiences. This includes engaging constructively with colleagues, patients, clients, and vendors in a manner that reflects professionalism, empathy, and cultural awareness, without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, or other protected characteristics as defined by applicable law.

Nice To Haves

  • BA or BS highly desirable
  • At least one year clinical and/or behavioral research experience highly desirable.
  • Familiarity working with people who are HIV infected or at risk for HIV infection highly desirable.
  • Phlebotomy experience highly desirable
  • Working knowledge of HIV pathophysiology, prevention, and treatment is highly desirable.
  • Experience working in an ethnically, culturally, and racially diverse environment preferred.

Responsibilities

  • Assists in Recruitment and Screening of Study Volunteers
  • Works with the study recruiters and staff to participate in the recruitment of study volunteers for specified clinical research trials.
  • Work with the recruitment team to identify creative measures for reaching potential study volunteers
  • Assists with telephone screening and scheduling of study volunteers.
  • Educates potential volunteers about the trial(s).
  • Reviews and discusses the informed consents with clients.
  • Conducts Clinical Procedures Using Established Protocols
  • Performs specified clinical procedures according to study protocols, which includes but is not limited to: phlebotomy, obtaining cultures, vital signs, updating medical histories, some point of care testing.
  • Transports, processes and ships laboratory specimens as needed.
  • Entering laboratory specimen into data management systems, as required.
  • Maintain inventory and ordering of laboratory supplies
  • Assists with medical/study procedures as required.
  • Provide referrals for study participants regarding medical, mental health or social issues.
  • Transport study products from study affiliated pharmacy
  • Ability to travel to multiple off-site locations to conduct study visits when required.
  • Provides Direct Counseling and Education to Study Participants as Specified by Study Protocols
  • Arranges, coordinates and takes part in intake appointments with new clients; assesses and documents eligibility and participation status of candidates; arranges follow-up appointments
  • Conducts pre-and post-test HIV counseling and education and risk reduction education per community and agency standard. Provides clients with emotional support and makes appropriate referrals to mental health and other support care providers as needed
  • Conducts behavioral interviews with study participants in a clear, open minded, non-judgmental context; maintains established guidelines of confidentiality and ethical accountability in all discourse with all study participants
  • Communicates and documents lab results to participant, other study clinicians and to primary care providers, as requested by participants, within the guidelines of informed consent and department policy.
  • Supports participants with navigation in the health care systems and works with client and organization to get them access to appropriate care/services.
  • Accurately Documents Study Protocol and Coordinates Research Studies
  • Completes Case Report Forms accurately and in a timely manner as is defined by study protocol.
  • Responds to data queries and meets with Study Monitors as indicated by the study sponsor within a timely manner.
  • Performs Quality Control checks of study documents and assures that corrections are made and documents as per site operating procedures.
  • Actively participates on study-related conference calls and attends study specific operations meetings as needed.
  • Informs Principal Investigator, Study Coordinator, Pharmaceutical Sponsor and Primary Care Provider, when patients suffer an adverse events within 24 hours.
  • Maintains drug accountability records for each study in progress and according to protocol.
  • Maintains study participant accountability records for each study in progress and according to protocol. Communicates to study staff and PI.
  • Actively participates in Quality Assurance activities that relate to the delivery of quality study participant care.
  • Attends Research Department In-services/Meetings on a regular basis.
  • Maintain study link files and excel databases with sensitive participant information
  • Meets Agency Participatory Expectation
  • Adheres to all agency and departmental policies and procedures
  • Participates in quality assessment and improvement activities as requested
  • Adheres to the highest principles of patient and client confidentiality
  • Adheres to established safety policies, procedures and precautions; identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation
  • Attends all required meetings, in-services and professional trainings
  • Maintains professional competence necessary to perform job responsibilities; maintain and
  • provides agency with records of continuing education activities as requested
  • Serves on agency committees and in professional organizations when requested
  • Manages Relationship with Study Sponsor and Investigators
  • Maintains regular communication with project principal investigators and co-investigators and collaborators.
  • Develops and disseminates weekly recruitments, enrollment and study progress reports
  • Develops and disseminates timely reports on serious adverse events and other critical study information to study PI and other.
  • Assists with logistics of study team meetings and conference calls.
  • Oversees the completion of tasks assigned to other staff members on the project
  • Manages and completes other tasks related to the projects as needed
  • Communicates regularly with study sponsors, monitors and investigators
  • Perform related duties as required

Benefits

  • We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match.
  • We also provide 12 paid holidays, paid vacation, and more.
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