About the job
Job Overview:
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.
Essential Functions:
Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
Assist with periodic review of study files and completeness.
Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
Act as a mentor for less experienced Clinical Trial Assistants (CTAs).
Assist with training and onboarding of new CTAs.
May serve as subject matter expert for business processes.
May lead CTA study teams.
May assist with interviewing and screening of potential new team members
May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.
May participate in departmental quality or process improvement initiatives.
Qualifications:
High School Diploma or equivalent Req
5 administrative support experience.
Equivalent combination of education, training and experience.
Minimum two years clinical research experience strongly preferred.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
Effective written and verbal communication skills including good command of English language.
Effective time management and organizational skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
Knowledge of applicable protocol requirements as provided in company training.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |California :
Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
Baltimore | Elkridge | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New York :
Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
Concord |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |Portugal :
Lisbon |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Quebec :
Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Harlow | London | Salt Lake City |Jakarta :
Jakarta |Republic of Ireland :
Limerick | Dublin |Israel :
Kfar Saba | Tel Aviv | Netanya |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Noord Holland :
Haarlem |Remote :
Remote - Europe | Switzerland | Remote, USA | Remote |Makkah :
Riyadh | Jeddah | Rabigh | Khulais | Najran |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |