FierceBiotech and FiercePharma Jobs
Senior Clinical Research Associate - Global Allied Pharmaceuticals
Jan 12
Location: Various Locations, Categories: Research Associate
Website: http://www.gapsos.com
Position Description
I Pre-Study Period
A. Tasks
Identify potential investigators for studies to be initiated.
Participate in pre-study and study initiation visits.
Ensure completeness and compile regulatory documents (e.g. IRB approval, informed consent, lab certification etc.).
Coordinate study material (e.g. CRFs Clinical Trial Material {CTM}) shipment and receipt by study site.
Report findings at pre-study and initiation visits in site visit report.
B. Knowledge and Skill Required to Complete Tasks
Working knowledge of FDA regulations, ICH Guidelines and HIPAA.
Understanding of corresponding standard operating procedures.
Ability to understand and coordinate multiple study protocols.
Oral and written communication skills.
Planning and organizational skills.
Understanding of clinical research principles and process.
Data collection and editing skills.
II Active Study Period
A. Monitoring Tasks
Assess protocol adherence at study site.
Ensure proper storage of CTM and documentation of CTM accountability.
Check CRFs for accuracy and completeness.
Verify adequate source documentation.
Transmit CRFs to appropriate person/persons.
B. Activities outside Monitoring Visits
Frequent and complete communications with sponsoring company.
Frequent and complete communications with study sites.
Maintain documentation of telephone communications.
Generate written correspondence with study sites.
Prepare reports of monitoring visits.
C. Knowledge and Skill Required to Complete Tasks
Working knowledge of FDA regulations, ICH Guidelines and HIPAA.
Understanding of corresponding standard operating procedures.
Ability to understand and coordinate multiple study protocols.
Knowledge of therapeutic areas.
Oral and written communication skills.
Planning and organizational skills.
Interpersonal skills.
Problem solving/decision making skills.
Attention to details.
Understanding of clinical research principles and process, data collection and editing skills.
III Study Termination Period
A. Study Termination Visit and Tasks
Complete CRF review, retrieve CRFs and transmit to appropriate person/persons.
Resolve data management queries.
Ensure compliance with regulatory requirements for CTM accountability.
Ensure compliance with regulatory requirements for study files.
Complete final study termination visit report.
Knowledge and Skill Required to Complete Tasks
Working knowledge of FDA regulations, ICH Guidelines and HIPAA.
Understanding of corresponding standard operating procedures.
Ability to understand and coordinate multiple study protocols.
Oral and written communication skills.
Planning and organizational skills.
Understanding of clinical research principles and process.
Data collection and editing skills.
OTHER SKILLS AND ABILITIES:
Expected Contacts Purpose of Contacts
CSMG Project Manager (Lead CRA)
Communications concerning all aspects of the study, scheduling of visits and sponsor expectations.
Sponsor Project Manager
Communications concerning all aspects of the study, scheduling of visits and sponsor expectations. Frequency and level of communications are dependent on instructions from the sponsor.
Sponsor CRA
Communications concerning all aspects of the study, scheduling of visits and sponsor expectations. Frequency and level of communications are dependent on direction from the sponsor.
Clinical Data Management
Communications regarding appropriate processing and handling of study data.
Clinical Investigators
Communications regarding conduct of study, timelines and schedules of visits.
Study Coordinator
Communications regarding conduct of study, CTM, regulatory requirements, data clarifications and visit schedules.
Study Pharmacist
CTM accountability, storage, handling and preparation.
REQUIREMENTS:
Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate OR
Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate OR
Eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a pharmaceutical or biotechnology company
