POSITION SUMMARY:

As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Clinical Trial Associate.

The Clinical Trial Associate (CTA) is required to help support Clinical Operations and project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

• Will interact directly with Clinical (e.g., CRAs, managers), site staff, vendors in U.S. and Europe (other worldwide, as necessary) to provide support in project-specific tasks and the overall management of clinical trials.
• Will directly support and supervision of Operational Team Leaders (OTLs), Study Team Leaders (STLs), and regional study managers, and, as requested by the OTL or STL, other study team members. Specific responsibilities include:
• Maintain and manage data entry into Intercept designated study systems to fulfill study requirements and be responsible for requests for access to study systems and deactivation of system users.
• Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
• Distribute safety alerts and relevant documents, if required.
• Maintain and update study team and Supplier contact information.
• Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates.
• May participate in reviewing, formatting and finalizing study-related templates, plans and manuals.
• Process, track and route invoices for approval in a timely manner.
• May participate in the negotiation and finalization of clinical trial agreements/contracts and escalate changes to relevant departments.
• Assist with maintaining clinical trial insurance.
• Assist with questions, issues or requests from the CRO/study team and route to the appropriate individual within the organization for resolution.
• May participate in data review, as required.
• Administration of the Trial Master File (TMF) - review of study, country and site documents for completeness and accuracy for inclusion into the TMF; build structure and maintain the TMF; evaluate progress through reports and reconciliations, determines gaps, follows up with internal and external functions to ensure maintenance of the TMF and propose solutions to resolve/document TMF non-compliance.
• Route, track and file Clinical documents. May conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates and distribute to appropriate team members for review.
• Develop and maintain study-related trackers that will support Clinical Operations and individual studies. May analyze or update data associated with the trackers.
• Other duties as assigned to support Study Team Leads and Operational Team Leads.
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Drive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients as our top priority

QUALIFICATIONS:

• Bachelor's degree, or equivalent, in a biomedical, life science or related field of study, preferred
• Minimum of 1-2 years of experience supporting life sciences with a general understanding of clinical trials.
• Familiarity with GCPs, ICH guidelines and FDA regulations. Familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements is a plus.
• Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.

REQUIRED KNOWLEDGE AND ABILITIES:

• Must possess a professional, "customer-service" demeanor and effective communication capabilities for collaboration with others in a multi-disciplinary group.
• Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
• Ability to effectively present ideas and document concepts in writing and orally.
• Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar databases required.
• Ability to think strategically in order to improve current processes.
• Strong verbal and/or written communications skills
• Learning agility and ‘scalability’ to take on increasing responsibility as Intercept grows
• Consistent demonstration and embodiment of our company core values: Come Together, Be Yourself, Own The Solution, Embrace The Challenge, and Keep Exploring
• Ability to have fun and thrive in a growing, diverse, and inclusive work environment

COMPANY CULTURE:

People at Intercept are passionate about patients. You’ll see our patient photos lining our walls and hear their stories in town halls. We’re equally passionate about our team and ensuring each member from all dimensions of diversity feels included and has the opportunity to reach their potential. We recognize the power of a diverse, equitable and inclusive (DEI) work force, and how it enriches the professional lives of our team members. Diversity, Equity, and Inclusion drives innovation and connects us to the patients and communities we serve.

At Intercept, we foster an environment that celebrates creativity, collaboration, and mutual respect. We never hesitate to lean on our teammates and work together. As we grow, we want to make every effort to provide a safe and open environment for professionals of every background and provide knowledge on how to work inclusively and equitably to make Intercept a great place to work.

Our relatively small size means you partner with accessible leaders who know you by name. This brings accountability and growth, which all add up to more opportunities to learn something new every day. For self-motivated leaders who are ready to make a difference in the lives of patients, Intercept is a great place to be.

COMPANY SUMMARY:

At Intercept, our mission is to build a healthier tomorrow for patients with progressive non-viral liver diseases. Intercept’s lead product, obeticholic acid (OCA), is a first-in-class farnesoid X receptor (FXR) agonist marketed under the brand name "Ocaliva®" in the U.S., EU and Canada for the treatment of patients with primary biliary cholangitis (PBC), a rare autoimmune liver disease. In 2016, Ocaliva® was the first medication to be approved for PBC in over twenty years, and sales continue to grow.

Intercept has also established the leading clinical development program in advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a disease that impacts the lives of millions of people in the U.S. alone and for which there are currently no available treatments. The 18-month interim analysis of the REGENERATE study of OCA remains the only readout from a Phase 3 trial to have shown positive results in the disease.

COMPENSATION & BENEFITS:

The anticipated starting salary range for this position is $79,000 to $100,000. This represents the anticipated low and high end of the salary range for this position. Actual salaries will vary and may be above or below the range, based on various factors including, but not limited to, experience, skillset, and performance.

The salary range listed is just one component of our total compensation package. Successful applicants will be eligible to receive annual bonuses and equity in the Company, at the discretion of the Company. Intercept also provides a competitive suite of benefits, including:

• 401(k) plan with company match
• Rewards and recognition program
• Health care benefits (medical, Rx, dental, and vision insurance)
• Sick and safe leave (unlimited, subject to certain limitations, and in accordance with disability coordination, as applicable)
• Parental leave benefits
• A generous Paid Time Off program of 20 days per year
• 10 paid holidays per year
• 4 paid Personal Days per year
• 2 paid Volunteer Days per year
• Numerous well-being and work-life programs

EEO Statement

Employment decisions at the Company are made without unlawful regard to race, color, religion, creed, national origin, alienage or citizenship status, sex (including gender, pregnancy, childbirth or medical conditions related to pregnancy or childbirth), gender identity or expression, sexual orientation, national origin, ethnicity, age, physical or mental disability, legally protected genetic information, marital or partnership status, sexual and reproductive health decisions, military or veteran status, or any other status protected by applicable federal, state, or local law.

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From: Intercept Pharmaceuticals