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Clinical Research Associate 2
Ref No.: 18-14451
Location: San Diego, California
MANAGER COULD CONSIDER A LEVEL 1 (1yr experience in clinical research) or LEVEL 2 (2-3yrs experience in clinical research)
Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols.
Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.
Assists in the development of study timelines and ensures compliance.
Assists in the management of vendors.
Prepares key reports and documents on progress of study for study manager.
Monitors adherence to the regulatory document collection process.
Interacts with data management, safety, regulatory personnel, and other functional groups.
Assists team members in reviewing data listings and writing queries.
Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance.
Reviews study specific ICF(s) for compliance with ICH/GCP and company SOPs.
Participates in CRF development and completion.
Top 5 Skills
1)Knowledge of Good Clinical Practice
2) Excellent communicator & experience interacting w/Principal Investigators/ Key Opinion Leader & representing the company in a professional manner
3) Excellent organizational skills, attention to detail & ability to multitask & prioritize individually & part of a team
4) Experience monitoring sites/data remotely & onsite
5) Lab experience (PPE, instrumentation) & technical experience (automated lab instrument, electronic database, clear queries & clean database) strongly preferred
Additional Comments/Miscellaneous:
Candidates must be able to work in San Diego office when not traveling
Candidate won't be testing samples in lab, but must be comfortable to enter lab to look at files on a lab instrument & wear personal protective equipment (PPE)
Willing to travel within the US

Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
Good knowledge of therapeutic area assigned.
Strong knowledge of ICH/GCP Guidelines and EDC process.
Strong verbal and written communication skills.
Ability to train others in using MS Office Suite, Impact, and EDC systems.
Ability to meet deadlines, multitask, and prioritize based on study needs.
Ability to make sound decisions based on available information.
Ability to establish rapport with site personnel/ colleagues.
Ability to work both in a team and independently.
Ability to facilitate team meetings and teleconferences.
Ability to present at internal study team meeting(s).
Ability to train and mentor junior CRAs.
Ability to seek new learning opportunities within and outside of the assigned project.
Ability and willingness to travel.