Company Description:
___________________________
Job Description:
We perform generic and innovator studies on in-house study subjects in our Phase 1 healthy studies facility.
Award winning benefits package includes Medical, Dental, Vision, Basic Life Insurance paid by company, Optional Life Insurance, Flex Accounts, 401K plan, performance incentive plan and childcare reimbursement.
The Clinical Project Manager, under the guidance of the Associate Director of Clinical Operations, is responsible for managing assigned in-house studies from study placement to completion of final study report. In addition he/she will be responsible for working as a team with other departments in the conduct of clinical trials.
DUTIES AND RESPONSIBILITIES:
The Clinical Project Manager’s responsibilities include, but are not limited to, the following:
• Always represents company in a professional manner (verbal, written and in appearance) when interacts with sponsors, subjects, outside vendors and fellow employees.
• Oversees Investigator schedules for coverage on in-house studies.
• Coordinates and projects scheduling needs for dormitories, housekeeping and meals for
all in-house studies.
• QCs all study related documents such as: IRB documents (Informed Consent, advertisement, etc.) prior to submittal, recruitment and screening forms, subject instructions, AE forms, Case Report Forms (CRF) format, etc.
• Coordinates and acts as liaison with clinical lab for coverage, testing, and turnaround
times for assigned studies as well as reconciliation of lab billing.
• Serves as a primary Sponsor contact for questions and study updates for assigned studies.
• Creates the flowchart of procedures for assigned studies.
• Prepares timelines for clinic portion of projects.
• Works with Corp Project Director in setting and meeting timelines for projects done together (Combo Projects).
• Communicates study information to appropriate internal staff at the clinic as well as the corporate office.
• Writes the clinical portion of the final report and review/QC study tables.
• Works with Sponsor to assure clinical supplies for assigned studies arrive in a timely manner.
• Works with Pharmacist to maintain and prepare paperwork for drug dispensation, retention samples, and dosing.
• Responsible for scheduling dosing procedures for assigned studies.
• Attends all internal study meetings for assigned studies.
• Attends Sponsor initiation meetings for assigned studies.
• Meets with Sponsor during his/her visits for assigned studies.
• Sets up audits as needed for pivotal studies; works with QA to schedule internal audits.
• Works closely with all departments to ensure good study communication and efficiency for assigned studies.
• Reviews costs and budgets to increase efficiency of study conduct.
• Helps train Coordinators as needed.
• Covers procedures as needed.
• Responsible for requesting, scheduling, and attending any training required for this position.
EDUCATION AND EXPERIENCE:
Required Education:
Bachelor degree with at least 5 years of clinical research experience.
Preferred Experience:
Bachelor degree (preferably in the field of Health); 3-4 years of Phase 1 experience; 2 years of supervisory experience.
SKILLS AND KNOWLEDGE:
Required:
Strong interpersonal and communication skills; excellent attention to detail; exceptional organizational and planning skills. Able to project and coordinate study needs in advance. Needs to have good trouble shooting and conflict resolution skills. Master at multi-tasking and handling more than one project simultaneously.
Preferred:
In-depth knowledge of the clinical research process, including Good Clinical Practices and ICH guidelines; able to make good, sound decisions under stress and with time restraints.
Sem comentários:
Enviar um comentário