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Clinical Research Project Manager - Kelly Clinical Research
Jan 25
Location: San Antonio, TXCategories: Clinical
Website: http://kellyscientific.com
Position Description
Exciting Direct Hire opportunity in San Antonio, TX
Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. KSR is the first and largest scientific staffing company in the world, and we currently have an exciting Clinical Research Project Manager position available in the San Antonio area.
The 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 Project Manager’s responsibilities include, but are not limited to, the following:
Oversee Investigator schedules for coverage on in-house studies.
Coordinate and project scheduling needs for dormitories, housekeeping and meals for all in-house studies.
QC all study related documents such as: IRB documents Informed Consent, advertisement, etc. prior to submittal, recruitment and screening forms, subject instructions, AE forms, CRF format, etc.
Coordinate and act as liaison with clinical lab for coverage, testing, and turnaround times for assigned studies as well as reconciliation of lab billing.
Primary sponsor contact for questions and study updates for assigned studies.
Create the flowchart of procedures for assigned studies.
Prepare timelines for clinic portion of projects.
Work with Project Director in setting and meeting timelines for projects done together Combo Projects.
Communicate study information to appropriate internal staff at the clinic.
Write the clinical portion of the final report and review/QC study tables.
Work with sponsor to assure clinical supplies for assigned studies arrive in a timely manner.
Work with Pharmacist to maintain and prepare paperwork for drug dispensation, retention samples, and dosing.
Responsible for scheduling dosing procedures for assigned studies.
Attend all internal study meetings for assigned studies.
Attend sponsor initiation meetings for assigned studies.
Meet with sponsor during his/her visits for assigned studies.
Set up audits as needed for pivotal studies; work with QA to schedule internal audits.
Work closely with all departments to ensure good study communication and efficiency for assigned studies.
Review costs and budgets to increase efficiency of study conduct.
Help train Coordinators as needed. Cover procedures as needed.
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:
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. 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.
For immediate consideration, click the ‘Apply Now!’ button, or refer a friend by clicking the ‘E-mail this job’ link provided.
Kelly Scientific Resources® has grown into a $270 million global business as the scientific business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food, pharmaceutical, biomedical, consumer products, environmental, medical device, medical laboratory, petrochemical, and clinical research.
We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyscientific.com
Kelly Services is an Equal Opportunity Employer
