Pharmaceutical Clinical Associates, LLC
-
Bala Cynwyd,
PA
Primary purpose and function of this position
Under the guidance of the Clinical Trials Manager or Clinical Trials Lead III, leads
clinical research trials in accordance with FDA regulations and ICH guidelines, good
clinical practices and company standard operating procedures and ensures
drug development project objectives are met.
Major duties and responsibilities that are critical and necessary, and that
must be done to achieve this position’s overall objective
% of Time
?? Manages single project; assures that project objectives are met: 50%
- Does project assessment and initiation, resource planning
and project implementation
- Assists in the writing and development of protocols and amendments
- Plans and tracks projects and produces key progress reports
- Reviews and tracks regulatory documents at study start-up and
during trial
- Develops monitoring tools for CRAs
- Reviews and designs case report forms
- Assures that projects adhere to GCP, CFR, ICH guidelines and
Teva SOPs
- Tracks progress of clinical study
- Delegates tasks to clinical project team members
- Authorizes drug shipments and tracks study supplies
- Assists in the development, tracking, and negotiation of
contracts for sites
?? Serves as back-up and/or primary contact and resource expert for vendors, 35%
CRAs, investigative sites, local and global team members:
- Oversees CRA activity relevant to the project requirements
- Provides project related training
- Provides input regarding team members’ performance
- Assists CRA Managers with interviewing candidates
?? Oversees communication among CROs, contract CRAs and global team members 10%
Partners cross-functionally with departments such as Pharmacovigilance 5%
Pharmacovigilance, QA, Regulatory and CRRC
+ Other duties and responsibilities as assigned
Travel: Approximately 10 - 30%, primarily domestic
Core Competencies (five or six) that an incumbent needs to be successful
in this position and that distinguish this position from others similar to it:
Technical
?? Demonstrates a basic understanding of Clinical Trials conduct
?? Demonstrates a basic understanding of ICH and GcP regulations and guidelines
?? Demonstrates a basic understanding of assigned protocols and CRF requirements
?? Demonstrates solid computer skills including MS Word and MS Excel.
Communication
?? Pro-actively and promptly updates/informs others of relevant concerns verbally and in
?? concise written form
?? Responds promptly and follows up to ensure action is taken on recommendations and
opportunities
?? Produces clear, concise reports with minimum guidance
Leadership
?? Delegates effectively
?? Leads, mentors, and assists
?? Recognizes contribution of associates and peers
?? Leads projects and other work
?? Explores and pursues opportunities to improve projects
?? Identifies and resolves issues
?? Understands goals and initiatives of upper management and integrates into work efforts
Planning and Organization
?? Sets appropriate priorities
?? Plans, organizes, manages and monitors activities according to priorities
Problem Solving
?? Identifies and solves problems proactively, not reactively
?? Skillful in negotiation to resolve issues and in gaining cooperation
Teamwork
?? Provides back-up and support to other team members
?? Shares ideas, information, and suggestions among team members
?? Fosters and maintains productive relationships with others to work for a common cause
Clinical Trials Lead I 3
Qualifications necessary to perform successfully in this position
Education required: RN or BS degree in allied health or life science or
equivalent combination of education and related work
experience
Experience and Skills:
Education preferred: Bachelor of Science.
Years of experience required: 2 years in-house or external clinical monitoring experience
Years of experience preferred: 3-4 years applicable experience including some clinical trial
management experience, as well as experience with
electronic data capture, remote data entry and clinical trial
management systems
Specific experienced preferred: CRA certification
Additional Information:
Job Level: Any
Number of Openings: 1
Years of Experience: At least 2 Years
Level of Education: BA/BS
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Bala Cynwyd, PA
Bala Cynwyd, Pennsylvania
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