Site: Mass General Brigham Incorporated

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.

The Clinical Research Data Specialist I (CRDS I) works under general supervision to extract clinical data and research data from electronic medical records and other sources and enters this data into electronic data capture system utilized for the clinical research protocol. The CRDS I will be responsible for entering data for multiple oncology clinical trials. The CRDS I will be trained on the institutional and federal regulations governing clinical research. The position involves a high volume of data abstraction and data entry. This position does not include any direct patient contact.

The CRDS I will perform the following responsibilities under general supervision by the Clinical Research Manager:

· Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker

· Effectively monitor research subject condition and take appropriate action to ensure compliance with research protocol data entry requirements

· Proactively take steps to obtain missing source documents from all relevant sources

· Identify inaccurate source documents and track source document inconsistencies until resolved.

· Ensure accurate and timely entry of required data into various study-specific electronic data-capture systems.

· Ensure appropriate documentation of own study-specific delegation and training prior to entering data.

· Ensure adequate source documentation is in place prior to entering data.

· Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.

· Independently manage adverse event (AE) and concomitant medication (CM) data as required by the sponsor, institution, and federal regulations

· Independently manage tumor response data entry

· Enter vital signs and EKGs into study-specific electronic data-capture system independently as required for individual studies

· Enter quality of life assessments into study-specific electronic data-capture system independently as required for individual studies

· Enter all required correlative research blood samples and clinical safety laboratory specimen results into study-specific electronic data-capture system independently as required for individual studies

· Enter all protocol required tests and procedures independently into study-specific electronic data-capture system as required for individual studies

· Work professionally with sponsor representatives to review and correct data recorded in the case report forms.

· Track and appropriately manage sponsor data entry deadlines

· Resolve and answer data queries with minimal errors.

· Perform standard data management quality control steps.

· Maintain awareness of details of clinical data to identify missing or inaccurate data; and track data inconsistencies for team to review and report accordingly.

· Remain flexible and adapt to change and variety on the job.

· Effectively handle unexpected situations and changing research subject and protocol conditions

· Develop individual research visit flow charts, intake sheets, and other tools as needed to independently ensure timely and accurate data entry


Skills/Abilities/Competencies Required:


· Careful attention to detail

· Good organizational skills

· Ability to follow directions

· Good communication skills

· Computer literacy

· Working knowledge of clinical research protocols

· Ability to demonstrate respect and professionalism for subjects’ rights and individual needs

Job Summary

Summary<br>Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research.<br><br>Does this position require Patient Care?<br>No<br><br>Essential Functions<br>-Maintain and organize study-specific regulatory binders. <br>
-Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB. <br>
-Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study. <br>
-Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required. <br>
-Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process. <br>
-Collect, complete, and submit essential regulatory documents to various regulatory entities. <br>
-Participate in monitoring visits and maintain a record of all correspondence related to these visits. <br>

Education
Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials

Experience
Research Related Experience 1-2 years preferred

Knowledge, Skills and Abilities
- Attention to detail.
- Ability to recognize compliance and data integrity issues and respond appropriately.
- Working knowledge of clinical research protocols.
- Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
- Effective interpersonal and communication skills.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

Remote

101 Merrimac Street

40

Regular

Day (United States of America)

Pay Range

$19.76 - $28.44/Hourly

Grade

5

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

0100 Mass General Brigham Incorporated 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 Veteran’s 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 (857)-282-7642.

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