Clinical Affairs Specialist

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Assist in the daily operations of one or more company-sponsored clinical studies, guiding them from planning and initiation through to reporting and closure, under the supervision of project leadership.

• Aid in the creation and upkeep of study plans, timelines, trackers, and operational documentation.

• Monitor study activities, site communications, and assigned deliverables to ensure alignment with project timelines.

• Collaborate with internal stakeholders, CROs, vendors, and clinical sites to facilitate study execution while ensuring that assigned tasks are completed in compliance with protocols and relevant regulations (e.g., GCP, FDA, ISO 14155).

• Assist in interactions with sites and vendors by coordinating study materials, communications, follow-up items, and documentation requirements.

• Elevate operational issues, delays, or risks to project leadership when necessary.

• Maintain proper study documentation, including the upkeep of the Trial Master File (TMF).

• Draft and review essential clinical documents such as Informed Consent Forms (ICFs), Case Report Forms (CRFs), tracking logs, operational plans, study plans, and Institutional Review Board (IRB) submissions.

• Support data review, cleaning, query follow-up, reconciliation, and problem resolution activities in partnership with data management, CROs, and study teams.

• Detect data discrepancies, protocol deviations, and documentation gaps, escalating issues as needed.

• Assist in study and clinical regulatory activities, including participation in study design, data review, protocol and report development, and contribute to the clinical sections of regulatory submissions (e.g., IDE, PMA, 510(k), EU MDR).

• Support audit and inspection readiness efforts, which include document preparation, follow-up, and resolution of assigned action items.

• Update company SOPs, templates, and protocols/reports to meet clinical requirements.

⛳️ Requirements

• A Bachelor's degree in life sciences or a related field.

• A minimum of 2 years of experience in clinical affairs, clinical research, regulatory affairs, or a related field, ideally within the medical device industry.

• Solid understanding of GCP, ICH guidelines, and applicable regulatory requirements.

• Experience collaborating with vendors, sites, and cross-functional teams.

• Exceptional organizational, problem-solving, and communication skills.

• Capability to manage multiple priorities in a dynamic environment.

• Strong attention to detail, focusing on data quality, documentation accuracy, and consistency in reporting.

• Basic understanding of clinical data analysis and issue resolution.

🏝️ Benefits

• Health insurance.

• 401(k) plan with up to a 6% employer match and no vesting period.

• Employee stock purchase plan.

• Flexible time off for salaried employees.

• Accrual of three to five weeks of vacation annually for hourly employees, based on tenure.

• Accrual of up to 64 hours of paid sick time annually.

• Paid and/or floating holidays.

• Parental leave.

• Short- and long-term disability insurance.

• Tuition reimbursement.

• Health and welfare benefits.