SR. CLINICAL OPERATIONS SPECIALIST
Reporting to the Associate Director, Clinical Operations or designee within the department of Clinical Pharmacology, the successful candidate will serve as the principal coordinator of activities by various contributing departments for the execution and delivery of multiple Clinical Pharmacology (Phase 1/2a) studies for programs in various therapeutic areas. Specifically, this individual will:
- Serve as operational study lead for assigned Clinical Pharmacology studies, participating in activities during pre-study, start up, conduct phase and close out.
- Ensure timely execution of studies in accordance with GCP and Client's SOPs.
- Assist in development of case report forms in collaboration with clinical team.
- Support site and vendor selection activities.
- Review study monitoring plans.
- Participate in reviewing and testing of specifications and edit checks for the electronic data capture (EDC) system.
- Review eCRF completion guidelines and lab requirements.
- Work with Data Management and Clinical Standards to ensure data collection meets standard.
- Develop and deliver study specific training presentations at study start and provide ongoing training to the sites during study conduct, as needed.
- Review/author informed consent forms and support their submission to IRBs.
- Author/review study procedure manuals, pharmacy manuals and/or laboratory manuals.
- Support enrollment projections and assist with the development and implementation of subject recruitment and retention strategies.
- Conduct study team meetings as appropriate; support the timely execution of milestones and discuss important study related information.
- Work closely with Bioanalytical Sciences department for pharmacokinetic/pharmacodynamic sample collection and processing activities for all clinical study phases (phase 1 through post-marketing).
- Document and track protocol deviations and violations.
- Report high-level issues to Clinical Pharmacologist and Safety Physician with an organized approach Provide viable options for resolution based on prior experience and current study trends.
- Respond to site and vendor issues.
- Generate and resolve data queries in EDC. Participate in SAE reconciliation with clinical team.
- Review and respond to Sponsor site audit findings.
- Work with Contracts Management/Procurement to review and execute site and vendor contracts.
- Coordinate successful transmission of all study data.
- Perform clinical data review of data listings and summary tables; review queries.
- Ensure completion of trial master files.
- Review drug packaging and labeling and oversee the shipment of drug supply to ensure delays do not occur.
- Track and manage study budgets and accruals efficiently and provide timely resolution to financial inquiries.
- Participate in the preparation of clinical trial synopses/outlines and protocols.
- Participate in process improvement activities.
- Create/revise SOPs related to clinical study operation activities.
- Provide support during CSR development, such as review of TFLs and CSR and availability of certain CSR components.
- May perform study monitoring, create/review study monitoring plans, and prepare monitoring visit reports, confirmation letters, and follow up letters.
- B.S. or M.S. degree in life sciences or equivalent, with at least 6 years of clinical research experience (including Phase 1) and at least 2 years of study management experience.
- Experience in developing study outlines and reviewing protocols; experience in data clarification and/or query resolution; knowledge of GCP/ICH guidelines and FDA regulations; knowledge of EDC system; and basic medical and scientific knowledge.
- Flexibility, multi-tasking and capability to take on additional responsibilities are a must.
- Adapt to a diverse work environment.
- Be efficient in Word, PowerPoint and Excel.
- CRA Training from a national clinical research association (e.g., ACRP, Barnett International, and PERI) is desirable.
This 5+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: firstname.lastname@example.org
ALPHA'S REQUIREMENT #18-00968
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE