Clinical Research Associate

Location
Emeryville, CA, United States
Posted
Nov 11, 2020
Ref
1033
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION

At Santen, we’re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Clinical Research Associate plays an integral role in the development and implementation of Clinical Research projects. Incumbent is expected to perform functions of minimal scope with moderate supervision for assigned clinical project (s) within the Global Clinical Operations (GCO) to support the development of innovative and differentiated products for the global ophthalmic market.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

As directed by management, the incumbent has significant responsibility for oversight of clinical operation activities for assigned projects including, but not limited to, the following:
  • Prepare all manner of clinical study related trackers to the clinical trial process (e.g., Study start-up tracker, Site document collection tracker, Site contract and budget negotiation tracker, Site recruitment tracker, etc.).
  • Participate in the selection of clinical study vendors.
  • Activate and manage clinical study sites throughout the clinical trial process.
  • Assist with selection of CROs and other contract vendors and provide oversight on the eTMF related activities to ensure outsourced tasks are performed in accordance with GCP and contract specifications.
  • Negotiate and prepare financial documents (e.g. confidentiality agreement, study contracts, budget proposals etc.).
  • Assist with the review and evaluation of minimum to moderate clinical data.
  • Attend project team meetings with vendors as required
  • Develop and maintain effective working relationships with other Santen functional areas and cross-cultural team members to facilitate clinical trials research.
  • Assist with creating study start-up package and provide oversight on the documents collected by CRO for the site activation.
  • Support non-project initiatives as GCO representative (e.g. CTMS or other technology initiatives) as requested by management.
  • Maintain up to date operational knowledge of Good Clinical Practices, regulations, and guidance documents and industry trends/best practices.
  • Suggest courses/seminars to attend to further develop professional expertise in clinical research.
  • No Travel required.
  • Perform other duties as assigned by management.

QUALIFICATIONS:

Core competencies, education, and experience.
  • A minimum of two (2) years of Clinical Research experience, preferably in Ophthalmology, with a BS degree in a scientific discipline, RN, BSN degree or equivalent.
  • Strong verbal and written communication skills and good interpersonal/group skills.
  • Must be able to communicate information between regions and with senior–level management both inside and outside of Santen.
  • Good document management skills to effectively assist with management of CROs and other vendors
  • Must demonstrate tact and ability to positively influence others in interpersonal and group interactions.
  • Knowledge of basic FDA and ICH regulatory requirements e.g. Guidances, guidelines, CFR, etc. and implementation guidelines.
  • High degree of computer proficiency preferably in MS Office environment. Highly detail oriented.
  • Adaptable to changing regulatory environments.
  • Must exercise good judgment regarding routine and non-routine assignments.
  • Must be able to set and prioritize goals and objectives with minimal input from management.