Sr. Clinical Project Associate
Proclinical is currently recruiting for a Sr. Clinical Project Associate with a globally leading pharmaceutical company located in South San Francisco, CA. Successful candidate will have at least 2 years of experience working within the clinical field and have a BS/BA.
- Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
- Participates in protocol review discussions concerning scientific and procedural aspects of study design.
- Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
- With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
- With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
- With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
- Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
- Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
- May be asked to coordinate teams and provide direction.
- May lead two or more specific components of departmental strategic initiatives.
- Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
Skills and Requirements:
- BA/BS required
- At least 2 years of experience in a clinical setting
- Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.