Clinical Study Team Assistant I - FSP

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Clinical Study Team Assistant (CSTA) I

__________________________________________________________________

Position Purpose:

The Clinical Study Team Assistant I (CSTA I) is an essential part of the Core Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, GCP, and SOPs. The role collaborates with global study team members and is responsible multiple for tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards.

The CSTA I:

Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams.

Works proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes.

Collaborates with global cross functional study team members of varying levels of seniority.

Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards.

Has fundamental knowledge of the principles and concepts related to the CSTA role.

Role Responsibilities:

With general direction, the CSTA I is responsible for providing study level operational support to the Core Study Team from study start up to close out and submission:

• Management and oversight of Study Team shared spaces

• TMF maintenance, compliance, and oversight

o Analyze, interpret, and follow up on metrics

• Management and oversight of Study Team on Demand (STOD)

o Analyze, interpret, and follow up on metrics

• Corporate Clinical Trial Registry (CCTR) compliance and maintenance

• Tracking and oversight of study level information; follow up with functional lines as needed.

• Liaising with cross functional study team members:

o Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems

o Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines

• QC of essential clinical trial, CSR and regulatory submission documentation

• Manage engagement of Independent Oversight Committees

• Provide support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities

• Provide logistical/operational support to Study Management for Investigator Meetings

Provide status updates on key tasks and activities to the CSTL and contributes to the Core Study Team Meetings as an active Core Study Team member.

On occasion, support short term Clinical Operations Special Project requests (eg workstreams, initiatives, projects).

Manage conflicting priorities to ensure excellent support to assigned study teams. Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables).

Collaborates with cross functional study team members to ensure completion of assigned tasks.

QualificationsBASIC QUALIFICATIONS

• 0-3 years exp with BA/BS or 0-1 years exp with MA/MBA/MS

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research

PREFERRED QUALIFICATIONS

• Science background

• Experienced with clinical trial applications

• Effective verbal and written communication skills

• Ability to work independently but also as part of a larger team with limited support from supervisor

• Ability to multitask and manage multiple competing priorities

• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality

• Knowledge of drug development process

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

• Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems