Clinical Research Associate II

Location: Bedford, MA

Position Scope:

The Clinical Research Associate (CRA) II will assist the Clinical Project Manager in the conduct of clinical trials.

Specific Responsibilities:

  • Conduct independent 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, Essential Documents, Case Report Forms and Investigator Agreements
  • Tracks progress of sites to initiation, enrollment and screening, interim monitoring and close out requirements
  • Ensure no study tasks are conducted prior to IRB/EC approval, CA/FDA approval, and formal site activation
  • Liaise with sites on study budgets and contracts with sites
  • Review Serious Adverse Event (SAE) narratives with sites and medical monitor; Ensure adverse event reporting is done in accordance with regulatory requirements
  • Maintain documentation in electronic and paper Trial Master Files
  • Maintain close communication with study sites, investigators, and vendors
  • Organize, conduct and report on Site Qualification, Site Initiation, Interim Monitoring, and Close-out visits
  • Verify the accuracy of study results
  • Identify and resolve site issues
  • Manage all aspects of relationship and operational activities for designated clinical investigational sites
  • Provide oversight of contract monitors to include co-monitoring
  • Participate in other duties and activities as assigned

Job Complexity:

Exercises judgment within defined parameters and policies. Job requires maintenance of up-to-date knowledge of all applicable regulations and guidance.

Supervisory Responsibilities: 


Required Qualifications:

  • Bachelor’s degree in the life sciences
  • 2+ years Registered Nurse or other relevant experience
  • Demonstrated detailed knowledge of guidelines, systems for clinical trial management and of ICH GCP, FDA, and international regulations and practices
  • Travel from 25%-75% may be required

Desired Experience, Knowledge, and Skills:

  • 2+ years of current clinical trial monitoring experience
  • Strong 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

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.