Clinical Research Associate
The Clinical Research Associate (CRA) will assist the Clinical Project Manager in the conduct of clinical trials. The position ensures the study is conducted in accordance with International Conference on Harmonization Good Clinical Practice (ICH GCP), US FDA and international regulations to ensure the safety and effectiveness of Anika products.
Strategic Focus Areas:
- Conduct studies in accordance with the approved protocol and in accordance with ICH GCP and applicable regulations
- Optimize resources within assigned areas to maintain compliance standards and cost discipline
- Create a positive image of Anika Therapeutics through communication and interaction with key stakeholders including employees, customers, partners, vendors, and appropriate government and regulatory authorities
Specific Tactical Responsibilities:
- Conduct monitoring to verify accuracy of study data vs. source records
- Ensure HIPAA requirements for patient privacy are met
- Generate and collect study documentation such as consent forms, Case Report Forms and Investigator Agreements.
- Maintain documentation in electronic and paper Trial Master Files
- Maintain close communication with study sites, investigators, and vendors
- Write Site Qualification, Site Initiation, Interim Monitoring, and Close-out visit reports.
- Provide oversight of contract monitors to include co-monitoring
- Verify the accuracy of study results
- Identify and resolve site issues
- Participate in other duties and activities as assigned
Exercises judgment within defined parameters and policies. Job requires maintenance of up-to-date knowledge of all applicable regulations and guidances. Site monitoring requires knowledge of the clinical indication, the medical status of the patient population, and details of the study device/drug and the protocol.
- Bachelor’s degree in the life sciences , RN, or other relevant experience
- Demonstrated knowledge of guidelines, systems for clinical trial management and of ICH GCP, FDA, and international regulations and practices
- Must be able to travel up to 25%
Desired Experience, Knowledge, and Skills:
- 2+ years of current clinical trial monitoring experience
- Medical and clinical knowledge of indications, therapies, and patient population
- Proven track record of having good sponsor, investigator, site, and vendor relations
- Strong computer skills including EDC system experience
- Excellent interpersonal, verbal, and written communication skills
- Attention to detail and strong organizational skills
- Good problem solving skills
- Enthusiastic and energetic