Senior Clinical Research Associate

Responsibilities:
- Participate in the preparation and execution of Phase 1-3 clinical trials.
- Oversee clinical investigations by conducting site qualification, initiation, interim, and close-out visits.
- Monitor trials in accordance with Good Clinical Practices (GCP) and ICH requirements, SOPs, local laws/regulations, protocol, and the Clinical Monitoring Plan.
- Develop and maintain collaborative investigational site relationships throughout the trial.
- Support site selection and qualification.
- Coordinate tasks to achieve site activation.
- Perform remote and on-site monitoring to protect subject rights, safety, and well-being; ensure data reliability and integrity.
- Conduct and document site visits; generate timely, accurate visit reports and letters.
- Review and verify study records (source documents, eCRFs, informed consent forms, and related materials).
- Resolve data queries/data entry errors and obtain additional information on potential serious adverse events.
- Assess and monitor investigational product receipt, storage, administration, accountability, and return.
- Collect/review essential regulatory documentation for study start-up, maintenance, and close-out.
- Submit documents to the TMF and resolve quality issues.
- Train and assist site coordinators/investigators (and CRO as applicable); serve as a resource on investigational products and protocols.
- Communicate and document site contact and issue information (protocol conduct, recruitment/retention, deviations, AE reporting, audits/inspections, site performance).
- Identify, assess, resolve, and escalate site performance/quality/compliance problems as needed.
- Assist with subject enrollment and recruitment strategies.
- Manage visit tracking and documentation in CTMS, eTMF, and other systems.
- Complete routine administrative tasks (e.g., timesheets, metrics, expense submissions).
- Ensure required trainings and study deliverables are completed per timelines.
- Perform other Clinical Operations duties as requested.

Additional (may be performed depending on assignment):
- Review protocols, eCRFs, study manuals, and related documents.
- Conduct CRA monitoring assessment visits; co-monitoring/data collection visits.
- Provide training/mentoring to more junior staff.
- Conduct monitoring oversight visits with CRO CRAs (MOVs) and review/escalate CRO monitoring report findings.

Required Qualifications / Skills:
- BS in biological sciences or related discipline with at least 5 years of CRA experience (or equivalent combination of education/experience).
- In-depth understanding of study protocol and procedures.
- Critical thinking, root cause analysis, and problem solving; ability to develop corrective and preventative actions.
- Ability to motivate site personnel to maintain/accelerate timelines to meet milestones.
- Demonstrated knowledge/application of GCP, ICH, and regulatory requirements; ability to comply with safety standards and maintain privacy/confidentiality.
- Excellent writing skills for clinical trial documents.
- Excellent interpersonal skills; strong oral/written communication and presentation skills.
- Excellent negotiation skills and tactful approach.
- Knowledge of latest trends in the clinical trial industry.

Preferred:
- Monitoring experience across clinical study startup, execution, and close-out; risk-based monitoring experience preferred.

Work/Travel:
- Travel up to 75% of the time.

Benefits (as stated):
- Discretionary annual target bonus; stock options; ESPP; 401(k) match.
- Health insurance (medical, dental, vision) and basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.