Administrative Coordinator I Psychiatry Translational Clinical Trials

Primary Location

 MA-Boston-BWH Boston Main Campus

Work Locations

BWH Boston Main Campus 

75 Francis St 

 Boston 02115

Job

 Clinical

Organization

 Brigham & Women's Hospital(BWH)

Schedule

 Full-time

Standard Hours 40

Shift

 Day Job

Employee Status

 Regular

Recruiting Department BWH Psychiatry

Job Posting

 Oct 6, 2023

The Department of Psychiatry at Brigham and Women’s Hospital is at the forefront of advancing the care of patients with mind-brain disorders through clinical, research, and educational innovation and excellence.  The Department of Psychiatry at the Brigham and Women's Hospital is a major teaching hospital of Harvard Medical School, and is dedicated to providing the highest level of care for patients and their families, informed by the innovative research being conducted by our renowned faculty.   

This Clinical Trial Coordinator position is for a Patient Centered Outcomes Research Institute (PCORI) study that will conduct a comparative effectiveness study between Electroconvulsive therapy (ECT) and Subanesthetic Intravenous Ketamine for Acute Suicidal Depression (ASD) lead by Principal Investigator (PI), Dr Amit Anand.   Dr. Anand is the Director of Translational Clinical Trials Program at Brigham and Women’s Hospital, Harvard Medical School. He also runs the Mood and Emotional Disorders specialty clinic. Dr. Anand has more than 25 years of clinical research experience in the area of mood disorders and has conducted and been a part of a number of mood disorders clinical trials as well as neuroimaging studies. He was part of the original team at Yale which discovered the antidepressant effects of ketamine in late 1990s.

The Clinical Trial Coordinator is part of the trial operations team, tasked with ensuring that each project is completed in compliance with the trial protocol, good clinical practice, regulatory requirements, and to sponsor standards.   This Clinical Trial Coordinator will work under the direction of the Project Manager and the PI and assist in all areas of trial management as needed.  The position will assist Dr. Amit Anand in coordinating clinical trials according to study guidelines and will be trained on supervising monitoring activities and to ensure appropriate payments to sites and stakeholders are made.

Candidates for this position should have a strong interest in clinical research and clinical trials. This position would be ideal for those candidates interested in gaining significant experience in medical research and learning from experienced clinicians and clinical trialists. 

Interested applicants should include an up-to-date résumé or curriculum vitae and a cover letter outlining how their interests and experiences would make them a good fit for this position.

Principal Duties and Responsibilities

1. Identify and initiate communications with sites to obtain all relevant documents for project/trial.
2. Collect and review essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval. 
3. Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
4. Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
5. Identify issues/trends that require escalation to management and provide input to resolution as appropriate.
6. Update and maintain internal databases, tracking systems, project plans, and study files.
7. Prepare presentation materials for internal and external meetings.  Draft meeting agendas and minutes.
8. Work with Project Manager to support trial processes and distribution of information and reports to monitors  
9. Facilitate the implementation and ongoing process improvement of established policies and procedures for department/project/trial. Comply with applicable SOPs. 
10. Maintain department service standards, with particular attention to person/behavioral, staff teamwork, and customer-staff interacting guidelines as outlined in the BWH Code of Conduct.
11. Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trial(s). 
12. Assists with the training of trial staff on all applicable study document management. 
13. Assists with staff regulatory and Sponsor requirement compliance through evaluation of expected versus actual output. Perform trend analyses to implement improvement strategies, to ensure compliance with US and international regulatory agencies, as well as Sponsor expectations. 
14. Using regulatory document knowledge assists project operations team in preparation of study start-up and closeout.
15. Perform other tasks, special projects, and responsibilities as directed.

Qualifications: 

• A bachelor’s degree is required, with minimum 1 year directly related post Bachelor’s degree experience required.
• Certification in clinical trials management strongly preferred. 
• Minimum of one year experience working in clinical research, academic research, or similar environment is preferred. 
• Exposure to clinical trials (such as prior research coordinator for interventional studies), or relevant employment in industry such as a CRO monitor is preferred. Clinical project management experience is preferred. 
• Exposure to IRB preparation, interactions with CROs, site monitors, regulatory paperwork regulatory paperwork, consenting and interacting with study subjects, strict protocol adherence and archiving is preferred. 
• Experience in financial aspects of clinical trial function such as invoicing and working with financial analysts preferred. 
• Familiarity with drug development, clinical research processes and documentation, (study start up, maintenance phase, and study close out procedures) preferred. 
• Familiarity with working in a large healthcare organization/ academic center encouraged.

Skills / Abilities / Competencies Required:

• Proficiency in MS Office products (Outlook, Word, Excel, and Powerpoint) and familiarity with databases 
• Proficiency in Adobe Acrobat applications preferred but not required 
• Highly detail oriented, strong initiative, and a can-do attitude 
• Excellent interpersonal skills are required for working with the multiple parties involved in the trials process. 
• Excellent organizational skills 
• Solid written and verbal communication skills 
• Strong sense of accountability, the ability to work autonomously, and as a team player 
• Ability to communicate effectively in a matrix environment 
• Ability to manage multiple tasks concurrently and to prioritize work appropriately 
• Ability to demonstrate professionalism 
• Willingness to ask questions when in doubt 
• Strong critical thinking skills and ability to independently resolve problems 
• Working knowledge of data management software and procedures 
• Working knowledge of clinical research protocols and Good Clinical Practice

 EEO Statement 

BWH is an Affirmative Action Employer.   By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.