<< Return to Careers

Senior Clinical Research Associate

Job Description
Designs‚ plans‚ and implements clinical research projects. Participates in and coordinates the protocol and final clinical study report writing efforts. Conducts pre–study‚ initiation‚ and interim clinical study monitoring visits. Coordinates activities of clinical site to ensure compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. Periodically travels to field sites to supervise and coordinate clinical studies. Drafts clinical study protocols. Job duties/responsibilities include:

  • Assist in managing clinical studies to ensure studies are completed on time‚ within budget and in compliance with SOPs‚ FDA regulations and ICH/GCP guidelines.
  • Perform the activities of planning‚ implementing‚ motivating‚ monitoring‚ managing‚ and tracking clinical trials.
  • Assist in the supervision of field monitors‚ and Contract Research Organizations.
  • Establish effective relationships with clinical investigators and staff.
  • Monitor sites and ensure compliance with protocols and overall clinical objectives.
  • Participate in the design and development of clinical trial protocols and case report forms and study documentation.
  • Assist in the preparation of clinical study reports and annual reports.
  • Generate and track drug shipments supporting clinical studies.
  • Work proactively with data management to identify and resolve data discrepancies.
  • Ability to travel up to 35% of the time (international and domestic sites).

Education

  • Bachelor’s degree in a scientific field. RN preferred.

Skills

  • Five or more years experience in clinical development.
  • Demonstrated management of regional and in–house CRAs and Clinical Support Teams a plus.
  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
  • Demonstrated proficiency in the implementation‚ motivating‚ monitoring and management of clinical trials/CROs‚ with outstanding communication and organizational skills and eye for detail.
  • Excellent oral and written communication skills.
  • Proactive in spotting potential problems and seeking successful solutions.
  • Known as a strong contributor in high performing teams.
  • Able to lead through influence; ability to develop collaborative internal and external relationships.
  • Experienced with successful juggling multiple teams‚ external sites and projects in a dynamic environment.
  • Computer proficiency (PC–Windows preferred).
  • Demonstrate conscientiousness and excellence in all tasks.