Clinical Affairs Specialist
About The Position
The Clinical Affairs Specialist is responsible for supporting the execution of clinical studies in support of product development, regulatory submissions, and post-market needs. This role ensures assigned study activities are conducted in accordance with applicable regulatory requirements, company SOPs, project timelines, and scientific principles. The Clinical Affairs Specialist collaborates cross-functionally with internal and external stakeholders to support high-quality clinical evidence generation. This role is customer/field-facing, requiring coordination with research sites, vendors, and study partners. This role combines strong execution responsibilities with technical depth in clinical research. As a Clinical Affairs Specialist, the individual supports study timelines, documentation, data review, issue resolution, and cross-functional coordination while developing hands-on expertise in clinical documentation, regulatory support, and clinical data interpretation. Success in this role requires the ability to manage multiple workflows while understanding and supporting the technical aspects of clinical study design, execution, compliance, and reporting. It is both operational and scientific, supporting the generation of high-quality, strategically aligned clinical evidence.
Requirements
- Bachelor’s degree in life sciences or related field.
- 2+ years of experience in clinical affairs, clinical research, regulatory affairs, or a related field, preferably in the medical device industry.
- Strong understanding of GCP, ICH guidelines, and applicable regulatory requirements.
- Experience working with vendors, sites, and cross-functional teams.
- Excellent organizational, problem-solving, and communication skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Strong attention to detail with emphasis on data quality, documentation accuracy, and reporting consistency.
- Basic understanding of clinical data analysis and issue resolution.
Responsibilities
- Support day-to-day activities for one or more company sponsored clinical studies from planning and start-up through reporting and close-out under the direction of project leadership.
- Support development and maintenance of study plans, timelines, trackers, and operational documentation.
- Track study activities, site communications, and assigned deliverables to support execution against project timelines.
- Collaborate with internal stakeholders, CROs, vendors, and clinical sites to support study execution and ensure assigned activities are completed in accordance with protocols and applicable regulations (e.g., GCP, FDA, ISO 14155).
- Support site and vendor interactions, including coordination of study materials, communications, follow-up items, and documentation needs.
- Escalate operational issues, delays, or risks to project leadership as appropriate.
- Maintain proper study documentation, including TMF maintenance.
- Draft and review key clinical documents such as ICFs, CRFs, tracking logs, operational plans, study plans, and IRB submissions.
- Support data review, data cleaning, query follow-up, reconciliation, and issue resolution activities in collaboration with data management, CROs, and study teams.
- Identify data discrepancies, protocol deviations, and documentation gaps and escalate issues appropriately.
- Support study and clinical regulatory activities including participation in study design, data review, protocol and report development, and contribution to clinical sections of regulatory submissions (e.g., IDE, PMA, 510(k), EU MDR).
- Support audit and inspection readiness activities, including document preparation, follow-up, and resolution of assigned action items.
- Update company SOPs, templates, and protocols/reports for clinical requirements.
Benefits
- 401(k) 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’ vacation annually (based on tenure) for hourly employees
- Accrual of up to 64 hours (annually) of paid sick time
- Paid and/or floating holidays
- Parental leave
- Short- and long-term disability insurance
- Tuition reimbursement
- Health and welfare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
