A Boston-based research group is building a team to enroll patients in a tissue banking initiative, gather their data and to process and ship specimens for proteogenomic analysis. The Research Data Coordinator position offers a wide variety of challenging and exciting opportunities to coordinate the development and management of this cancer research program.
What You'll Do
Perform all aspects of regulatory-related work including timely reporting of adverse events to the Institutional Review Board (IRB), preparation and submission of initial study submissions, continuing reviews, protocol amendments, consent form changes, and notification of study closings for IRB review
Assists with preparation of budgets, statements of work, deliverables and timelines
Create study-specific flow sheets and data forms to be used as source documents by study staff to collect data
Collaborates with study team and BVARI staff, establishes and follows processes for trial administrative management
Follows center standard operating procedures
Effectively communicate between study site, sponsor, auditors, and Institutional Review Board. Interact with Principal Investigator (PI) and other research and clinical personnel to ensure accuracy and completeness of data collection and to meet all project timelines
Keep the PI informed of progress and potential problems
Work closely with study monitors to ensure protocol compliance and accuracy of data
Prepare and clean-up study files, documents, and data for internal and external audits
Identify and recruit potential study patients for participation in clinical trials
Determine eligibility of potential study patients through review of patient's medical history, current chart, and laboratory data
Describe and discuss protocol with potential study patients
Providing teaching to patients regarding study procedures
Obtain informed consent from study patients
Administer questionnaire to study patients
Coordinate the collection and processing of required samples (blood draws, tissue, etc.)
Act as a primary contact and resource for study patients regarding study related issues
Review and abstract patient's medical data for completion of case report forms
Maintain integrity and confidentiality of data, private health information and personal identifying information
Performing data entry into electronic case reports forms or complete paper case report forms
Review and resolve data queries
Maintain study-related documentation
Who You Are
Experienced: You hold a bachelor's or master's degree preferably with coursework in biology, chemistry, epidemiology and/or statistics. May have previous experience with human research trials.
Tech Savvy: You have no problem learning new software. Prior knowledge of specialized computer software (i.e., Medidata Rave, MS Word, PowerPoint, and Excel) and email systems is helpful.
Composed: You are an excellent communicator (verbal & written). You have critical problem solving and analytics skills. You can juggle the coordination of multiple projects and can learn to master research infrastructure.
Customer Service: You must meet the needs of customers (veterans, patients, research participants, their representatives, visitors, and all VA staff) while supporting VA research missions. You must consistently communicate and treat customers in a courteous, tactful and respectful manner. You must provide customers with consistent information according to established policies and procedures.
Confidential & Compliant: You are able to operate 100% confidentially and able to to ensure compliance with study protocols, Good Clinical Practice standards, and Health Research Protection Program (HRPP) rules, policies and procedures. You can effectively solve compliance issues.
About BVARI
Founded in 1990, BVARI is one of Boston's only small non-profits in biomedical research. We are a strategic partner to the VA Boston Healthcare System, which maintains academic affiliations with several prestigious universities in Boston. We enable top-notch research programs, driving major advances in a number of high-priority disease areas affecting the US veteran population and translating to the general public. Our small business setting is ideal for highly intelligent and driven leaders wishing to make a big impact in the workplace. Every role at BVARI is essential to driving excellence, and every individual is highly valued and challenged to grow and thrive within our environment. We encourage shining stars who wish to push traditional corporate boundaries, deeply broaden their knowledge base, and influence outcomes to apply.
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The candidate must reside in Massachusetts.
Physical Demands
The physical demands described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee frequently is required to stand; walk; use hands; and reach with hands and arms.
This position requires the ability to occasionally lift office products and supplies, up to 20 pounds.
Position Type/Expected Hours of Work
This is a full-time position, and hours of work and days are Monday through Friday, 8:30 a.m. to 5 p.m.
Travel
No travel is expected for this position.
Work Authorization/Security Clearance
An employee in this position must complete all appropriate background checks at the time of hire and periodic reappointment.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Equal Opportunity Employer
Boston VA Research Institute provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfer, leaves of absences, compensation and training.