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Location

Boston, MA | United States

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Job description

Join an innovative team at the forefront of clinical research in the vibrant city of Boston! We are a dynamic organization dedicated to advancing healthcare through impactful clinical trials in the field of oncology.

Position Overview:
Are you passionate about making a difference in the world of clinical research? We are seeking a motivated and detail-oriented individual to join our team as a Clinical Research Associate (CRA). As a vital member of our organization, you will play a key role in managing various aspects of site and project management, contributing to groundbreaking advancements in oncology.

Roles and Responsibilities:

Collaborate with our operations team to support Alliance member sites, escalating issues when necessary.
Facilitate the study feasibility process by sending, tracking, and reviewing questionnaires.
Contribute to site selection and recruitment by generating site identification reports and overseeing site accruals.
Track training information and issue trainings for sites and contacts.
Collect essential documents for study start-up and review Investigational Product (IP) release packages.
Prepare and execute Investigator meetings and other training programs.
Assist in creating start-up plans and templates.
Ensure proper and timely filing of study documents into the eTMF to ensure compliance.
Accurately manage data within the Clinical Trial Management System (CTMS).
Participate in co-monitoring activities.
Communicate effectively with CROs, vendors, and study sites to support ongoing studies.
Conduct regulatory review of Informed Consent Form (ICF) changes.
Coordinate study-related meetings, taking detailed minutes, and distributing decisions and action items to the team.
Requirements:

BA/BS degree required, preferably in a health or science major.
2-4 years of relevant experience in biotech, pharma, and/or CRO, with at least 1 year in clinical research.
Working knowledge of clinical monitoring responsibilities and procedures.
Previous experience with eTMF, CTMS, and IRT clinical trial systems preferred.
Proficiency in Microsoft Office Suite, especially Word and Excel.
Flexible and adaptable to a dynamic workplace environment.
Must be authorized to work in the U.S.
Fully COVID-19 vaccinated.
Boston area residency required; no relocation assistance offered.
Benefits:

100% Medical, Dental & Vision coverage for employees, with 50% coverage for spouse and children from day one.
Generous PTO, Sick Days, and Holidays.
Tuition Reimbursement.
3% matching contribution to a Simple IRA.
50% Transit or Parking expenses covered.
Annual Employee Bonus Program.
Annual Cost of Living Increase.
If you are ready to be part of a team driving impactful clinical research in a dynamic environment, apply now! We look forward to welcoming passionate individuals who share our commitment to advancing healthcare.
Employment Type: Full-Time
Salary: $ 77,000.00 Per Year

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