What are the responsibilities and job description for the Clinical Studies Specialist position at PSG Global Solutions?
Company Description
At Real we're always looking for new and ambitious people to help deliver exceptional service levels, change the lives of the candidates we represent and partner with some of the world's best pharmaceutical, biotechnology and medical companies.
As specialists in recognizing talent we pride ourselves on not just finding the best people for our client partners but on our ability to spot the best and brightest talent to work for us. We are also renowned for providing training and long-term career opportunities to help our employees be the best they can be, so they can continue to deliver the expertise Real has become famous for.
Relationships are at the heart of everything we do and ensure that our clients and candidates continue to work with us again and again. This ethos is also what shapes how we work as a business. We encourage and reward knowledge sharing and have various support networks and international forums to enable our employees to keep up-to-date with changes happening across their industries and share local insight to deliver true global perspectives.
Job Description
• Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines.
• Support clinical team, primarily in tracking, organizing and filing Phase I-IV study documents according to Federal Regulations and ICH guidelines.
• Assist Clinical Team members in handling data queries, drug inventories, study invoice payments, enrollment tracking, and record reconciliation with site documents.
• Assists the CRAs with organizing and planning study investigator meetings.
• Ensure documents are compliant with SOPs and regulatory requirements.
• Review essential/critical documents for completeness and accuracy.
Qualifications
• A Bachelor’s degree is required.
• Pharma experience or professional equivalent is required.
• Strong documentation or research experience
• Multiple TAs. Ability to manage clinical documents for multi-site studies.
• Ability to prioritize multiple tasks and/or projects with limited supervision.
• Ideal candidates will possess strong organizational capabilities and strong interpersonal skills, excellent written and verbal skills.
• Candidates must have a stable work history.
• Foreign MD will be considered only if candidate also has clinical research experience.
Additional Information
All your information will be kept confidential.