Clinical Research Coordinator

JOB SUMMARY:

The Clinical Research Coordinator under the guidance and supervision of the Principal Investigator (PI) and the Clinical Research Nurse Coordinator supports the integrity and quality of human subjects research (clinical trials) maintained and conducted in accordance with federal state and local regulations Institutional Review Board (IRB) approvals and MAHEC policies and procedures. The Clinical Research Coordinator supports the coordination and timely handling of the operational aspects of the clinical research protocol including pre-and post-research activities in and outside the clinical setting. The Clinical Research Coordinator helps implement clinical research projects develops effective recruitment strategies coordinates participant protocol treatment schedules and participatesin recruitment screening scheduling testing and data management for multi-faceted investigations. The Clinical Research Coordinator typically works on multiple research projects simultaneously.

SPECIFIC RESPONSIBILITIES:

In general:

• Working as part of a multidisciplinary research team.

• Understand and perform trial work in accordance with Good Clinical Practice (GCP) standards.

• Support communication among interdisciplinary partners to support the development and execution of research and evaluation projects including MAHEC Mission Health and Community team members.

• Provide operational feedback to managing staff

Study Specific:

• Assist the clinical trials team in assessing the feasibility of and planning for each study.

• Perform clinical and administrative tasks in the implementation of clinical trials which may include:

• Recruiting enrolling and scheduling participants in compliance with regulatory and monitoring agency standards and institutional guidelines

• In partnership with the Principal Investigator and Clinical Research Nurse Coordinator execute the informed consent process explaining studies to participants answering questions and documenting the consent process

• Assure compliance with receiving monitoring and documenting the dispensing of investigational drugs and devices as well as drug and device disposition at study close

• Obtaining vital signs (e.g. blood pressure pulse oxygen saturation weight) medical history medication history and other clinical data questionnaires

• Performing medication reconciliation and baseline clinical assessment

• Collecting biologic specimens

• Performing laboratory specimen processing

• Recording scanning uploading study-related documentation per protocol procedural manual and MAHEC protocols and policies

• Obtaining processing and shipping biological specimens according to protocol and IATA requirements

• Completing follow-up with study participants over phone video conference or in-person

• Providing participant education and responsive support with investigational drugs or devices and trial activities

• Understand and support operational procedures amendments and adverse event reports as required by theIRB and study sponsors

• Support the maintenance of study regulatory binder and participant charts according to protocol and/or institutional requirements

• Assisting investigators in organizing study data for progress reports and analysis

• Performing study closeout procedures per protocol

• Perform other related duties and participate in special projects as assigned

• Requires adherence to HIPAA regulations

This role description is a general description of the essential job functions. It is not intended to describe all the duties the Clinical Research Coordinator may perform.

SPECIFIED SKILLS

COMPUTER

• Excellent skills in Microsoft Office including Word Excel PowerPoint and database applications .

• Experience with Electronic Medical Records.

OTHER

• Understanding of clinical trial processes Good Clinical Practice (GCP) and regulatory requirements (such as FDA IRB).

• Knowledge of research protocols principles and procedures related to clinical trialssuch as screening interviewing and case report forms; basic knowledge of experimental design computerized information retrieval systems and computer data management; ability to identify produce organize data; knowledge of or ability to learn ethics and regulatory procedures (e.g. informed consent process data safety and monitoring plans principles of data collection and documentation) involved with clinical research; ability to work as a member of a project team.

PHYSICAL DEMANDS

• Light - Moderate energy level: Lift and carry 25 - 35 lbs Push/Pull 50 - 100 lbs (empty bed stretcher etc.)

• Physical Activity: Occasional (0 - 33% of Workday)

SUPERVISORY RESPONSIBILITIES:

• Not Applicable.

EDUCATION AND EXPERIENCE

MINIMUM QUALIFICATIONS:

• Bachelors Degree in a related field of study such as biology health sciences nursing or a similar discipline with at least 1-2 years of experience in a clinical research healthcare laboratory or related setting.

or

• An equivalent combination of education and experience which includes:

• Licensure and experience as an Emergency Medical Technician (EMT) Paramedic Pharmacy Technician Licensed Practical Nurse (LPN) Associate Degree Nurse (AND) or Certified Medical Assistant (CMA) with a minimum of 3-5 years of experience in a healthcare laboratory or clinical research setting.

• 2-3 years of experience in clinical trials data management regulatory compliance or a related research setting preferably as a Clinical Research Assistant or similar role.
• Must complete CITI certification for Human Subject Research within 3 months of hire if not already completed.

PREFERRED QUALIFICATIONS:

• SOCRA or ACRP certification preferred