Part-Time Senior Clinical Research Associate (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.

Position Purpose:

The Senior Clinical Research Associate (SCRA) will act as a primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Organizational Relationships:

· Reports to ExecuPharm (EP) assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.

Primary Duties:

· Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Client

SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

· Gains an in-depth understanding of the study protocol and related procedures.

· Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

· Performs remote and on-site monitoring & oversight activities using various tools to ensure:

o Data generated at site are complete, accurate and unbiased

o Subjects’ right, safety and well-being are protected

· Conducts site visits including but not limited to co-monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

· Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

· Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

· Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with project team.

· Manages and maintains information and documentation in the Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), and various other systems as appropriate and per timelines.

· Supports and/or leads audit/inspection activities as needed.

· Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.

· Adhere to EP and Client SOPs and processes.QualificationsSkills and Education:

· Min. 4 years of direct site management (monitoring) experience in a bio/pharma/clinical research organization (CRO).

· B.A./B.S. preferred with strong emphasis in science and/or biology

· Ability to travel domestically approximately 65%-75% of working time.

· Expected travelling ~2-3 days/week.

· Current driver’s license preferred.EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.