Senior Clinical Study Associate
Senior Clinical Study AssociateAllakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:Provides support to clinical projects under direction of Clinical Program Managers and/or other designated clinical team members. The position requires a highly-motivated individual to work collaboratively in a cross-functional team environment. This individual will play a key role in ensuring excellence in a fast-paced, start-up biotech environment.
- Assists Clinical Project Managers with successful study start up, maintenance, and study closure activities.
- Contacts clinical study sites by e-mail and/or phone to obtain information and documentation regarding the status of the study (includes enrollment metrics, drug inventory, etc.).
- Inquire and track IRB Submission and Approval status for sites.
- Review IRB Approved Consent form and completion of ICF Approval Form.
- Track Informed Consent Form Approvals.
- Updates and maintains tracking systems and tools with status of documents, key dates, etc.
- Assist with clinical data mining, review, and reconciliation as needed.
- When needed, assists with Clinical Site Study Binder creation, assembly, and shipments if the individual lives less than one-hour travel time of the Redwood City, CA office.
- Assists with equipment shipping and tracking to clinical sites.
- Provide and maintain systems access for EDC and IWRS.
- Assist the Trial Master File team to ensure that all relevant documents are collected and uploaded.
- Participate in on-site meetings with clinical team at Headquarters in Redwood City, CA, as needed after safety concerns with travel and COVID-19 subside.
- Work alongside the Call Center to track referrals for studies receiving referrals.
- Work with other clinical team members as needed on various tasks.
Qualifications and Expertise:
- Minimum of four (4) years of experience in the pharmaceutical/biotechnology industry or other related relevant experience (e.g. study coordinator); BA/BS or equivalent experience preferred.
- Ability to work remotely at home if candidate is not within commuting distance of the Redwood City, CA office. Candidate may live anywhere in the United States.
- Work independently or with small teams in a fast-paced, non-traditional work environment in a start-up, clinical stage biotechnology company.
- Excellent written and oral communication skills.
- Strong general administration skills and experience.
- Proficient in the use of the Microsoft Office suite of products, including Word, Excel, PowerPoint and Outlook and the Internet.
- Excellent interpersonal skills and the ability to work well and flexibly in small teams and with a wide range of varying stakeholders.
- Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
- Strong focus on quality of work.
- Excellent attention to detail.
- Availability to travel for clinical team meetings and/or Investigator Meetings if needed.