Note: The job is a remote job and is open to candidates in USA. Haemonetics Corporation is a company focused on providing innovative solutions in the healthcare sector. They are seeking a Clinical Affairs Specialist responsible for supporting the execution of clinical studies, ensuring compliance with regulatory standards, and collaborating with various stakeholders to generate high-quality clinical evidence.
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
Skills
- 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
Benefits
- A 401(k) with up to a 6% employer match and no vesting period
- An employee stock purchase plan
- “flexible time off” for salaried employees
- For hourly employees, accrual of three to five weeks’ vacation annually (based on tenure)
- 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
- Incentives may also be provided as part of Haemonetics’ employee compensation
- For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms
- For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms
- Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role
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