Clinical Research Coordinator II NEUROLOGY HL

Site: The Brigham and Womens Hospital Inc.

Mass General Brigham relies on a wide range of professionals including doctors nurses business people tech experts researchers and systems analysts to advance our mission. As a not-for-profit we support patient care research teaching and community service striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

New budgeted research role

Job Summary

Summary

Works independently and under general supervision from the Administrative Director of the CNCT and the Principal Investigator to support clinical research studies. This role may be responsible for the following activities: making independent judgments of the suitability of potential participants for clinical trials developing and implementing patient recruitment strategies recommending protocol changes and overseeing the work of more entry-level staff. Collecting and organizing patient data; scheduling patients for study visits; maintaining and updating data generated by the study; all IRB submissions such as applications amendments annual reviews and adverse events and communicating with national and international research collaborators.

Following established policies procedures and study protocols provides assistance on clinical research studies including recruiting evaluating and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy EKGs etc.; maintaining and updating data generated by the study. Additionally it provides input into determining study subject suitability and input into recruitment strategy. Performs data analysis interpretation QA/QC and assists in completing reports and presentations.

Does this position require Patient Care
No

Essential Functions

- Assists with determining the suitability of study subjects and acts as a resource for patients and families.
- Has input into recruitment strategies and may contribute to protocol recommendations.
- Administers scores and evaluates study questionnaires.
- Maintains research data patient files regulatory binders and study databases.
- Performs data analysis and QA/QC checks and organizes and interprets data.
- Assists with preparation for annual review and assists PI in completing study reports and presentations.
- May assist with training and orientation of new staff members.

Principal Duties and Responsibilities

- Assists with clinical research studies as per study guidelines and protocols.
- Screen for eligibility recruit and evaluate potential study patients. Per protocol instruction conducts telephone interviews or schedules patients for in-person study visits and screening.
- May be required to perform clinical tests such as questionnaires cognitive assessments etc. if certified and as needed. Will work with colleagues in research labs to set up lab testing shipping etc.
- Responsible for collecting data and maintaining the patient information database for several studies. It may be required to input data. Maintains study subject records as a part of the record-keeping function. Prepares data for analysis and data entry.
- Interact with patients/subjects regarding the studies including patient education procedural instruction and follow-up. Prepare materials to advertise studies. Answers any phone calls and inquiries regarding study protocol. Refers participants when appropriate to supervisor or clinical staff.
- Will serve as a liaison between patient and physician. First point of contact for study communication. Advocate for patients to ensure a good experience while in your trial and assure compliance.
- Communicates with sponsor companies CRAs central labs and testing facilities both external and internal.
- Responsible for scheduling all research meetings with monitors or sponsors.
- Creates distributes and files all study documents per protocol and updates them as needed.
- Responsible for various study information or packets i.e. schedules directions and reimbursements to study participants.
- Responsible for staff study training.
- Prepares and submits all IRB documents: applications amendments annual reviews and serious adverse events.
- Oversees study budgets and patient reimbursements.
- Monitors and sets up any needed equipment.
- Maintains inventory and orders supplies when necessary.
- Maintains all study regulatory documents.
- All research administrative tasks.

Education
- Bachelors Degree Science required


Experience
- Related post-bachelors degree research experience: 1-2 years required.

- At least one year of work experience in a research setting. Sound independent judgment and competence in research methodologies.

Knowledge Skills and Abilities

- Excellent interpersonal skills are required to work with the study participants PIs research collaborators colleagues and supervisors.

- Good oral and written communication skills.

- Knowledge of clinical research protocols.

- Knowledge of GCP and ICH guidelines.

- Knowledge of computer programs databases etc.

- Able to work independently.

- Able to multi-task on several project simultaneously and shift focus multiple times per day.

- Able to work under deadline pressure Ability to problem solve quickly and accurately.

- Excellent organizational skills and ability to prioritize and delegate a variety of tasks.

- Careful attention to detail.

- Ability to demonstrate professionalism and respect for subjects rights and individual needs.

- Ability to work with vulnerable subjects (pregnant women with neurologic illness).

- Basic knowledge of human anatomy physiology pharmacology
- Computer literacy analytical skills and ability to resolve technical problems.
- Ability to interpret the acceptability of data results.
- Working knowledge of data management programs.

Working Conditions

Work throughout the hospital areas such as clinic labs clinical trials center. Must be able to go independently to the investigational drug services pharmacy on L-2 to pick up investigational product to clinic on ground and first floor. Daily operations conducted in open office cube space. May be required to lift boxes to ship to central lab or boxes of lab supplies.

Onsite

60 Fenwood Road

40

Regular

Day (United States of America)

The Brigham and Womens Hospital Inc. is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact Human Resources at .

Mass General Brigham Competency Framework