Clinical Affairs Associate

About Discovery Life Sciences:

Discovery Life Sciences (Discovery) is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model.

Discovery Life Sciences is a trusted provider of quality biospecimens and laboratory services to hundreds of researchers across the U.S. and around the world. The Clinical Affairs Associate contributes to our mission by overseeing our clinical sites to implement, expand and improve the processes and relationships of Discovery Life Sciences throughout its clinical site network. This individual will collaborate with other members of the Clinical Affairs team to monitor and execute all processes for Discovery Life Sciences to obtain maximum effective and efficient performance.

Essential Duties/Responsibilities:

• Supervise all activities at assigned sites, which include coordination of all activities between the DLS and Sites.

• Manage relationships at assigned sites and expand capabilities to incorporate new sites and procedures.

• Maintain and grow collaborative relationships with all site personnel involved in DLS research.

• Develop, coordinate and enforce systems, policies, procedures, and productivity standards.

• Stay abreast of industry-accepted procedures.

• Serve as liaison between DLS and sites to execute projects and maintain quality standards.

• Partner with Quality and the site’s Regulatory on promptly reportable incidents (PRIs) or non-conforming events.

• Assist in the development and execution of site-specific performance plans.

• Travel to clinical sites at a minimum quarterly.

• Review and evaluate research requests to determine how sites can fulfill requests.

• Evaluate gaps in sourcing capabilities and implement plan for addressing sourcing needs.

• Maintain accurate data in Salesforce database and utilize communication tools.

• Develop and lead site specific implementation plan for initiation (SIV) and closing of clinical sites.

• Collect regulatory documentation, file properly, and ensure accuracy.

• Maintain digital site binders and ensure documents update.

• Upload regulatory documents and track expiration dates.

• Update site specific files and trackers.

• Manage, coordinate, and support clinical site monitoring activities according to the Site Monitoring Process for IMVs.

• Schedule visits, obtain proper access (remote, if needed) and maintain all applicable correspondence.

• Resolve issues from previous visits, address protocol questions, and ensure outstanding documents are completed properly.

• Resolve site and/or monitoring issues including appropriate retraining, issue escalation, and implementation of corrective actions (CAPA) to prevent recurrence, as needed.

Qualification/Experience:

• 3-5 years of comparable or related medical laboratory and/or clinical research experience

• Knowledge of clinical research trials and previous managerial experience preferred

• CCRA, CCRP, or equivalent certification preferred

• Candidate should be familiar with principles, concepts, and standard of care associated with clinical trial or research study design and execution

• Experience in a clinical research organization or oncology/infectious disease/autoimmune research.

• Experience clinical study technologies, including electronic data capture (EDC) is a plus

• Highly developed organizational and analytical skills with the ability to multitask, prioritize time-sensitive activities and work both independently and as part of a team in a matrix environment

• Excellent presentation, communication and relationship-building skills

• Thrive in a challenging and results-oriented work environment.

• Ability to build and nurture relationships with clinical site partners

• Ability to develop and implement strategic solutions to optimize and maximize site relationships