POSITION TITLE: Senior Clinical Research Associate, Clinical Operations
REPORTS TO:  Director, Clinical Operations
POSITION TYPE:  Full-time, exempt position

PharmaIN Corporation is a privately held clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, peptide-based therapies for liver diseases and in oncology.We seek a highly motivated, results-oriented, collaborative and agile leader with global clinical operations and drug development experience who has a passion for operational excellence to fill our Senior Clinical Research Associate (Sr. CRA) position to join our growing Clinical Operations group. This position may manage and mentor less experienced staff including entry level Clinical Research Associates (CRAs), and Clinical Trial Assistants (CTAs).

The Sr. CRA will independently manage assigned aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a larger-scale study. This position works closely with the Clinical Trial Manager and Director, Clinical Operations, the cross-functional team, vendors and CRO team members, and clinical site staff to ensure compliance with clinical study protocols, to ensure overall study objectives and timelines are met. Additionally, this role will be responsible for implementing and monitoring clinical study activities to ensure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), study protocols/procedures, and applicable regulations.

KEY RESPONSIBILITIES:
Serves as a crucial member of the PharmaIN Clinical Operations study team for the quality execution of assigned clinical protocols according to PharmaIN SOPs, ICH/GCP, to achieve corporate and departmental program goals.

• Supports the Clinical Trial Manager and Director, Clinical Operations on assigned program(s) as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.
• Oversee assigned aspects of study/vendor/site management to ensure high quality data is collected, processed appropriately, and available as planned.
• Participates in the review of study designs from an operations and site perspective, provides input into protocol patient assessments and site implementation tactics.
• May support CTM in the review of CRO/Vendor RFPs and participate in vendor bid defense meetings and reviews, and comments on proposals for clinical vendor selection.
• Supports CTM in the development of study timelines and budgets per corporate and departmental goals, and continuously strives to ensure timelines and deliverables are met within budget.
• Develops or contributes to study processes in support of the protocol, develops workflow and resource plans to achieve interim goals; modifies workflow and plans as needed according to study progress.
• Escalates concerns regarding timelines, milestones, resourcing, and any potential study execution issue to the CTM and department leadership.
• Collaborates with CTM and Clinical Quality staff to develop a quality plan, including audit readiness assessments for assigned clinical trials.
• Participates in the development of critical study documents (protocol, informed consent forms, Case Report Forms, SAE forms, templates, site management, and monitoring tools, and other clinical documents as assigned).
• Participates in the oversight and maintenance of internal and CRO maintained Trial Master Files (TMF) to ensure inspection readiness. Assists with periodic TMF reviews and audits.
• Works with outsourced or in-house data management groups to create and implement study-specific tools to ensure clean data, e.g., metrics reports, patient profiles, etc.
• May communicate with chemistry, manufacturing, and controls (CMC) team to forecast and monitor drug supply and expiration to ensure adequate availability throughout the trial. May review site-specific accountability logs to ensure accuracy and report findings to CTM.
• Participates in the evaluation of clinical study reports for accuracy, safety, and/or efficacy trends as necessary for medical monitor review and/or Safety Review Committee or IDMC meetings.
• Participates in or leads in the development and maintenance of essential trial documents.
• Tracks and submits essential documents to regulatory agency for IND updates and amendments per the recommended timelines of the CTM. Maintains a complete and updated regulatory document file and communications file for each assigned site.
• Participates in the recruitment of potential Investigators suitable for assigned clinical trials.
• Participates in the review and negotiation of site budgets and contracts. May oversee site payment process, and initiate site payments.
• Supports the CTM in oversight of monitoring aspects of clinical study. Participates in the development of, and ensures compliance with, the clinical monitoring plan.
• Conducts sponsor oversight visits and may conduct site qualification visits and site initiation visits. Co-monitors as needed for staff training and quality assurance (QA) purposes.
• Assists in the management of study drug and lab supplies at clinical sites to ensure adequate inventory, and research sample shipments from clinical sites to lab vendors.
• Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and drug product related questions, safety, regulatory, and legal questions.
• Works with the CTA to ensure the meeting agendas and meeting minutes are created, tracked, distributed, filed, and are accurate.
• Participates in the recruiting and onboarding process for other clinical operations staff. Provides mentorship for less experienced staff, CRAs and/or CTAs.
• May lead or contribute to development of departmental processes and initiatives; contributes to the development of standard operating procedures (SOPs), templates and forms and processes.

Qualifications:
Must have strong knowledge of clinical drug development processes, clinical study design, study planning and management, and monitoring.

• Bachelor’s degree or equivalent in relevant field, nursing degree, or equivalent experience
• 4+ years of clinical trials experience, including CRA/field monitor in pharmaceutical, biotech or CRO setting; 2 + years with a sponsor organization a plus.
• Previous clinical site level trial management experience is a plus.
• Technical knowledge and experience in the planning, launching, monitoring, and closeout of Phase 1-3 clinical trials. Previous experience on multi-national clinical trials a plus (e.g., Europe, Canada, Asia Pacific regions).
• Strong knowledge of CFR, ICH, GCP and GDPR/data privacy requirements.
• Experience in complicated disease states including oncology, immune-oncology, hematology, or liver disease states.
• Experience operationalizing innovative, complex trial designs preferred (such as basket study, adaptive or continuous review trial designs).
• Strong understanding of the application of SOPs, and medical terminology.
• Ability to read and understand scientific literature.
• Experience with industry standard data management systems, trial master files, clinical trial management system platforms. Previous participation in the successful set-up and management of CROs and associated vendors, (e.g., IRT, central labs, data management, central imaging vendors, eCOA) a plus.
• Ability to review and analyze performance metrics through various systems for assigned areas of responsibility and vendors and drive actions toward improving results.
• Strong problem-solving skills with ability to anticipate issues and outcomes and respond strategically, proposing innovative “outside the box” solutions to challenges, including obtaining input from colleagues to derive solutions.
• Experience and competent at developing and delivering effective presentations in multidisciplinary settings.
• Excellent interpersonal and communications skills with the ability to work collaboratively as a member of a cross-functional team.
• Self-starter, comfortable and effective working in a hybrid work environment with department and cross-functional colleagues, and vendors based in different geographies.
• Strong attention to detail, and organizational and time management skills with ability to prioritize tasks to meet critical deadlines.
• Ability to prioritize urgent and important tasks and take necessary actions to inform/escalate to management and stakeholders as appropriate.
• Ability to utilize a wide range of computer applications and tools. Proficiency with MS Office Suite, Word, Excel, PowerPoint, SharePoint, TEAMs; Smartsheet and MS Project experience a plus.
• This position may require occasional work on weekends to attend scientific meetings or attendance at site/investigator study training meetings.
• This position requires up to 30% domestic travel and may include limited international travel. Has current or able to obtain passport for international travel.

ESSENTIAL TRAITS

• Willingness to “roll-up sleeves” and get work done to meet department and company goals and milestones.
• Leads by example and learns from mistakes
• Effectively pivots to meet changing demands in priorities
• Clearly communicates milestones, risks, mitigations, and essential feedback
• Comfortable communicating to stakeholders
• Values the input of colleagues and is a collaborative team player
• Works efficiently without compromising quality
• Innovates and eliminates redundant, inefficient, and manual processes where feasible

Location: Our offices and labs are located in Bothell Washington, just north of Seattle. This position is a hybrid position with preference of location in greater Seattle area.

COMPENSATION:

This is a management-level position with a compensation range of $100,000 to $135,000 for a Senior Clinical Research Associate.

At PharmaIN we engage equitable workplace strategies to ensure fair compensation. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location, in addition to internal equity, and alignment with current market data. We take care of our employees and offer generous benefit plans, flexible paid time off and competitive pay. We strive to make PharmaIN an environment where all employees can succeed.

The PharmaIN Team shares a passion for meaningful work and is committed to solving complex problems in liver diseases and in oncology to create new therapies for patients suffering with these diseases. We believe in innovative thinking, collaboration, flexibility, action, and healthy debate.

PharmaIN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. PharmaIN is also committed to compliance with all fair employment practices regarding citizenship and immigration status.