Clinical Research Monitor BWH Timi Study Group

4 weeks ago

Boston, United States Brigham and Women's Hospital Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Field Clinical Research Associate (Field Monitor) is primarily responsible to ensure the assigned site study staff conduct the study in compliance with the currently approved protocol/amendment(s) and trial operations manual. The position will perform on-site visits, such as Qualification, Site Initiation, Interim Monitoring and Study Close-out Visits, in accordance with the Monitoring Plan. Field Monitor will comply with TIMI's Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH)/Good Clinical Practices (GCPs), and applicable regulatory requirements. Responsibilities may also include observation of participant visits, performing source document verification, query resolution, triaging site issues, conducting staff training and collaborating with in-house Clinical Trial Protocol Coordinators, to ensure regulatory documents and the Investigator Site Files (ISFs) are complete and current. May also serve as a mentor and coach to junior staff.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1.Responsible for overall on-site monitoring activities of assigned clinical sites. Includes but is not limited to:

a.Independently conduct all types of monitor visits, onsite qualifying site assessments, recruitment, initiation, for-cause, interim and closeout, and/or remote visits as needed, in accordance with the Monitoring Plan.

b.Perform source document verification/review in accordance with the Monitoring Plan

c.Schedule and conduct visits in accordance with the Monitoring Plan

d.Complete monitoring visit reports and enter them into an electronic database, confirmation letters, and follow up letters on time, in accordance with Monitoring Plan and/or TIMI SOPs and Guidelines.

2.Observe participant clinic visits and provide feedback to study coordinators on adherence to trial protocol and operations manual, as appropriate.

3.Perform Informed Consent Form (ICF) reconciliation to ensure all trial subjects have fully completed and signed the correct version of the form. Collect and submit other regulatory documents as necessary.

4.Effectively perform protocol and other on-site study training to investigator and site study staff.

5.Perform drug and/or device accountability.

6.Review ISF and resolve noted deficiencies in a timely manner.

7.Identify and resolve site level Corrective and Preventative Actions (CAPAs) in a timely manner, in coordination with Clinical Trial Protocol Coordinators.

8.Perform Trial Master File maintenance.

9.Co-monitor as needed or facilitate co-monitoring visits from the trial sponsor or TIMI.

10.Attend and participate in investigator and coordinator meetings as requested.

11.Assist with site preparation for audits (Regulatory Agency, Sponsor, etc.).

12.Available to support site staff for studies not currently involved in performing on-site monitoring

13.Ability to audit monitor performance for studies not currently performing on-site monitoring, as requested.

14.Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations related to Field Monitoring.

15.Maintains department service standards as outlined in the BWH Code of Conduct.

16.Performs other duties as required.

Bachelor's Degree required, in science/health related field preferred.

Minimum of 5 years in clinical trial related experience for large, multi-center national and/or international clinical trials or 3 years of TIMI specific experience.

Previous clinical monitoring experience preferred.

Certified Clinical Research Professional (CCRP) or equivalent and/or Certified Clinical Research Associate (CCRA) preferred.

Experience with cardiovascular studies and medical terminology preferred.

Knowledgeable of Electronic Data Capture Systems (e.g InForm, eCOS, IWRS) preferred.

Working knowledge of HIPAA

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

1.Ability to accept a responsibility for decision-making as it relates to the conduct of field monitoring for large domestic and international clinical trials.

2.Excellent judgment and ability to interpret information and protocol requirements, and initiate appropriate actions given competing priorities.

3.Outstanding interpersonal and leadership skills to effectively interact with Sr. Management, Principal Investigators, Trial Staff, and to represent TIMI Study Group to sponsors and regulatory authorities (domestic and international).

4.Outstanding written and oral communication skills to work with individuals from various fields of expertise and with participants from various backgrounds, and to function effectively as a member of a research team.

5.Outstanding organizational abilities to formulate and complete rigorous timetables.

6.Ability to travel nationally on short notice

WORKING CONDITIONS:

May be expected to conduct 8-10 field visits per month, although percent of travel is dependent on study specific need. Travel will also be required to attend Investigator Meetings, Site Visits, and Professional conferences.

FISCAL RESPONSIBILITIES:

Will be required to complete expense reports in accordance with TIMI Study Group expense guidelines.

  • Clinical Research Coordinator BWH TIMI Study

    5 days ago

    Boston, Massachusetts, United States Brigham & Women's Hospital(BWH) Full time

    The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners...

  • Clinical Research Coordinator BWH TIMI Study

    4 days ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System.The candidate must possess ability to work independently in all phases of human clinical research.S/he must comply with all Partners...

  • Clinical Research Coordinator BWH TIMI Study

    4 weeks ago

    Boston, United States Brigham and Women's Hospital Full time

    The TIMI Research Coordinator is responsible for coordinating human clinical research activities, for multiple clinical trials, involving subjects recruited from multiple facilities within the Partners Healthcare System. The candidate must possess ability to work independently in all phases of human clinical research. S/he must comply with all Partners...

  • Finance Coordinator TIMI Group BWH

    3 weeks ago

    Boston, MA, United States Mass General Brigham Full time

    DescriptionGENERAL SUMMARY/OVERVIEWUnder the general direction of the Director of Finance, and the day-to-day supervision of the Assistant Director of Finance and Administrator, provides full scopeof basic financial and administrative support to the TIMI Study Group, which coordinates large, multi-center, national and international clinical trials. ...

  • Research Assistant Ii Bwh Cardiovascular

    1 week ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Research Assistant II BWH Cardiovascular** - (3291232) Working very independently and under very general supervision from a manager or Principal Investigator (PI), provides support to clinical research studies. May be responsible for the following activities: making independent judgment of suitability of potential participants for clinical trials,...

  • Research Assistant I Bwh Cardiovascular

    1 month ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Research Assistant I BWH Cardiovascular** - (3287497) Working very independently with little guidance from Project Manager and/or Principal Investigator, coordinates all activities of research area including but not limited to supervising the daily activities of research assistants, implementing and maintaining quality assurance procedures, performing...

  • Research Assistant I BWH Neurology Fox Lab

    4 days ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

     Job Description - Research Assistant I BWH Neurology Fox Lab (3288885)   Working under the supervision of a Senior Research Assistant, Manager, or Principal Investigator and following established policies and procedures, provides assistance on clinical research studies. May be responsible for the following activities: recruiting and evaluating patients...

  • Research Assistant I BWH Neurology Fox Lab

    5 days ago

    Boston, Massachusetts, United States Brigham & Women's Hospital(BWH) Full time

    Job Description - Research Assistant I BWH Neurology Fox Lab Working under the supervision of a Senior Research Assistant, Manager, or Principal Investigator and following established policies and procedures, provides assistance on clinical research studies. May be responsible for the following activities: recruiting and evaluating patients for studies;...

  • Research Assistant I BWH Sleep Medicine

    5 days ago

    Boston, Massachusetts, United States Brigham & Women's Hospital(BWH) Full time

    Job Description - Research Assistant I BWH Sleep Medicine General Summary/ Overview StatementThe Research Assistant (RA) will support various projects within the Program in Sleep Medicine Epidemiology and Sleep and Cardiovascular Medicine within the Division of Sleep and Circadian Disorders at Brigham and Women's Hospital. The RA will work under the general...

  • Clinical Investigation Technician I Bwh Sleep

    4 weeks ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Clinical Investigation Technician I BWH Sleep Medicine** - (3288129) GENERAL SUMMARY/ OVERVIEW STATEMENT: The Sleep Disorders Research Program is committed to find cutting edge technologies to predict sleep apnea diagnosis and outcome and is paving the way to find pharmacotherapy for sleep apnea. The Sleep Disorder Research Program has considerably...

  • Research Assistant Ii Gastroenterology

    1 month ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Research Assistant II Gastroenterology** - (3286859) GENERAL SUMMARY/ OVERVIEW STATEMENT: The RA2 is responsible for evaluating and tracking the recruitment process including outcomes, expenditures, and reporting to investigators on outcomes related to study progress. The assistant must conduct all study related activities according to HIPAA and IRB...

  • Clinical Investigation Technician II Rotating BWH Sleep Medicine

    5 days ago

    Boston, Massachusetts, United States Brigham & Women's Hospital(BWH) Full time

    Working under general supervision of the DSCD Clinical Research Program Coordinator, Director, and/or DSCD Investigators, and following established policies and procedures, assists in the execution of clinical research protocols and operations in the Division of Sleep and Circadian Disorders (DSCD). Responsible for assisting with the recruitment of study...

  • Clinical Investigation Technician I Rotating BWH Sleep Medicine

    5 days ago

    Boston, Massachusetts, United States Brigham & Women's Hospital(BWH) Full time

    Working under general supervision of a manager or project leader and following established policies and procedures, assists in the execution of clinical research protocols and operations in the Division of Sleep and Circadian Disorders (DSCD). Responsible for assisting with the recruitment of study participants; collection of physiologic data using...

  • Research Assistant I, Infectious Disease

    1 month ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Research Assistant I, Infectious Disease** - (3287159) Working under the supervision of a Principal Investigator and Research Coordinator and following established policies and procedures, assists with clinical research studies. May be responsible for the following activities: recruiting and evaluating patients for studies; collecting and organizing...

  • Research Assistant I, Dom Infectious Diseases

    1 month ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Research Assistant I, DOM Infectious Diseases** - (3287158) Working under the supervision of a Principal Investigator and Research Coordinator and following established policies and procedures, assists with clinical research studies. May be responsible for the following activities: recruiting and evaluating patients for studies; collecting and organizing...

  • Clinical Research Assistant I, Lz, Hybrid

    1 month ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Clinical Research Assistant I, LZ, Hybrid** - (3287392) - General Summary/Overview Statement_ In affiliation with the Division of General Internal Medicine and Primary Care (DGIM), the RA I will have numerous voluntary opportunities for training and career development. DGIM holds a monthly medical seminar for RAs with review of clinical case studies and...

  • Research Scientist

    1 week ago

    Boston, United States Brigham & Women's Hospital(BWH) Full time

    **Research Scientist - BWH Rheumatology** - (3291658) **General Summary** **Primary Responsibilities** The position requires the ability to develop an in-depth understanding of our research questions as well as the data and data structures. Willingness to learn new skills and ability to work in a team setting is essential. The position includes...

  • Scheduling Research Program Coordinator, BWH CCI

    4 weeks ago

    Boston, United States Partners Healthcare System Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The mission of the Center for Clinical Investigation (CCI) is to strengthen the culture for clinical research at the Brigham and Women's Hospital, by building services helpful to clinical investigators and facilitating the success of individual investigators. Working very independently and under very general supervision...

  • Clinical Research Coordinator I BWH Rheumatology

    4 weeks ago

    Boston, United States Partners Healthcare System Full time

    This individual is a research assistant who will work with a cutting-edge research team in the areas of translational immunology and autoimmune diseases. The research assistant will be an integral member of the research teams and will lead the consent, enrollment, and data collection for one or more research studies. This individual may also have the...

  • Coop, Research, BWH Men's Health

    5 days ago

    Boston, Massachusetts, United States Brigham & Women's Hospital(BWH) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT:The Men's Health, Aging and Metabolism Clinical Research Unit at Brigham and Women's Hospital conducts government and industry sponsored clinical trials, covering a wide range of therapeutic areas, with study populations that include both women and men.Under the supervision of the Principal Investigator (PI) and Project...