Clinical Research Associate II

Tasks an****************

Perform the activities of mot******** mon******** an******** ClinicalStudy Sites worldwide an******** site compliance with protocolan******** study object******** SOPs, applicable regulationsan********/GCP guidelines.
Conduct site ******** site ******** routine monitoring an******** closeout visits an******** the corresponding reports.
Establish effective relationships with clinical investigatorsan********.
Assist Clinical Study Sites with IRB/EC submissions an********collection an******** of require******** study documents an********.
Work proactively with data management team to identify an******** datadiscrepancies.
Track study progress using study tracking tools, ensuring timelyan******** updates to the system used.
Provide study an******** status reports an******** any necessaryrecommendations for mitigation an******** planning.
Participate in the design an******** of clinical trial protocols, casereports forms, an******** study documentation.
Assist with contract negot******** site budgets an******** as needed.
Assist with CRO an******** management, as needed.
Develop strong working relationships an******** effective communicationwithin the Clinical Department as well as other functional departmentswithin the company.
Participate in other project or departmental tasks as neede********ensure studies an******** are complete******** time an******** budget.
Manage, mentor an******** junior staff an******** team, as needed.

Competencie********

Excellent verbal an******** communication skills.
Excellent organ******** recor********, time management, decisionmak******** customer serv******** an******** skills.
Goo******** of written an******** English language.
Plans an******** decisions by considering impact from all relevantperspectives; able to verbalize decisions in a thorough an********manner.
Able to proactively identify an******** areas of inefficiency an********creat******** successful solutions.
Holds self an******** accountable for adherence to high work an********standards.
Flexible; adapts work style in order to meet department an********needs.
Deals with broad, new issues with limite******** or direction.
Develops solutions base******** limite******** an********.
Experience with protocol writing an******** report form design.
Computer proficiency (MS Word, Excel) required. Experience with MSAccess an******** Project a plus.
Ability to travel as required.

Require******** & Experience:

Bachelor’s degree or equivalent in the life sciences or relate********required; advance******** (Master’s or above) preferred.
1-3 years’ experience as a CRA including the ability to interacteffectively with investigators an********-functional teams.
Knowledge of GCP, GLP, ICH guidelines an******** US an******** clinicalregulatory requirements.
Demonstrate******** to organize an******** scientific information (e.g.,clinical study results) to internal an******** audiences.
Strong work ethic an******** ability to deliver assignments on time.
Professional use of the English language both written an******** is required.